[Congressional Record (Bound Edition), Volume 153 (2007), Part 8]
[Senate]
[Pages 10767-10797]
[From the U.S. Government Publishing Office, www.gpo.gov]




                           TEXT OF AMENDMENTS

                                 ______
                                 
  SA 983. Mr. VITTER submitted an amendment intended to be proposed by 
him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic 
Act to reauthorize and amend the prescription drug user fee provisions, 
and for other purposes; which was ordered to lie on the table; as 
follows:

       At the end of subtitle E of title II, insert the following:

     SEC. __. COUNTERFEIT-RESISTANT TECHNOLOGIES FOR PRESCRIPTION 
                   DRUGS.

       (a) Required Technologies.--The Secretary of Health and 
     Human Services shall require that the packaging of any 
     prescription drug incorporate--
       (1) radio frequency identification (RFID) tagging 
     technology, or similar trace and track technologies that have 
     an equivalent function;
       (2) tamper-indicating technologies; and
       (3) blister security packaging when possible.
       (b) Use of Technologies.--
       (1) Authorized uses.--The Secretary shall require that 
     technologies described in subsection (a)(1) be used 
     exclusively to authenticate the pedigree of prescription 
     drugs, including by--
       (A) implementing inventory control;
       (B) tracking and tracing prescription drugs;
       (C) verifying shipment or receipt of prescription drugs;
       (D) authenticating finished prescription drugs; and
       (E) electronically authenticating the pedigree of 
     prescription drugs.
       (2) Privacy protection.--The Secretary shall prohibit 
     technologies required by subsection (a)(1) from containing or 
     transmitting any information that may be used to identify a 
     health care practitioner or the prescription drug consumer.
       (3) Prohibition against advertising.--The Secretary shall 
     prohibit technologies required by subsection (a)(1) from 
     containing or transmitting any advertisement or information 
     about prescription drug indications or off-label prescription 
     drug uses.
       (c) Recommended Technologies.--The Secretary shall 
     encourage the manufacturers and distributors of prescription 
     drugs to incorporate into the packaging of such drugs, in 
     addition to the technologies required under subsection (a), 
     overt optically variable counterfeit-resistant technologies 
     that--
       (1) are visible to the naked eye, providing for visual 
     identification of prescription drug authenticity without the 
     need for readers, microscopes, lighting devices, or scanners;
       (2) are similar to technologies used by the Bureau of 
     Engraving and Printing to secure United States currency;
       (3) are manufactured and distributed in a highly secure, 
     tightly controlled environment; and
       (4) incorporate additional layers of non-visible covert 
     security features up to and including forensic capability.
       (d) Standards for Packaging.--
       (1) Multiple elements.--For the purpose of making it more 
     difficult to counterfeit the packaging of prescription drugs, 
     the Secretary shall require manufacturers of prescription 
     drugs to incorporate the technologies described in paragraphs 
     (1), (2), and (3) of subsection (a), and shall encourage 
     manufacturers and distributors of prescription drugs to 
     incorporate the technologies described in subsection (c), 
     into multiple elements of the physical packaging of the 
     drugs, including--
       (A) blister packs, shrink wrap, package labels, package 
     seals, bottles, and boxes; and
       (B) at the item level.
       (2) Labeling of shipping container.--Shipments of 
     prescription drugs shall include a label on the shipping 
     container that

[[Page 10768]]

     incorporates the technologies described in subsection (a)(1), 
     so that members of the supply chain inspecting the packages 
     will be able to determine the authenticity of the shipment. 
     Chain of custody procedures shall apply to such labels and 
     shall include procedures applicable to contractual agreements 
     for the use and distribution of the labels, methods to audit 
     the use of the labels, and database access for the relevant 
     governmental agencies for audit or verification of the use 
     and distribution of the labels.
       (e) Penalty.--A prescription drug is deemed to be 
     misbranded for purposes of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 301 et seq.) if the packaging or 
     labeling of the drug is in violation of a requirement or 
     prohibition applicable to the drug under subsection (a), (b), 
     or (d).
       (f) Transitional Provisions; Effective Dates.--
       (1) National specified list of susceptible prescription 
     drugs.--
       (A) Initial publication.--Not later than 180 days after the 
     date of the enactment of this Act, the Secretary shall 
     publish in the Federal Register a list, to be known as the 
     National Specified List of Susceptible Prescription Drugs, 
     consisting of not less than 30 of the prescription drugs that 
     are most frequently subject to counterfeiting in the United 
     States (as determined by the Secretary).
       (B) Revision.--Not less than annually through the end of 
     calendar year 2010, the Secretary shall review and, as 
     appropriate, revise the National Specified List of 
     Susceptible Prescription Drugs. The Secretary may not revise 
     the List to include fewer than 30 prescription drugs.
       (2) Effective dates.--The Secretary shall implement the 
     requirements and prohibitions of subsections (a), (b), and 
     (d)--
       (A) with respect to prescription drugs on the National 
     Specified List of Susceptible Prescription Drugs, beginning 
     not later than the earlier of--
       (i) 1 year after the initial publication of such List; or
       (ii) December 31, 2008; and
       (B) with respect to all prescription drugs, beginning not 
     later than December 31, 2011.
       (3) Authorized uses during transitional period.--In lieu of 
     the requirements specified in subsection (b)(1), for the 
     period beginning on the effective date applicable under 
     paragraph (2)(A) and ending on the commencement of the 
     effective date applicable under paragraph (2)(B), the 
     Secretary shall require that technologies described in 
     subsection (a)(1) be used exclusively to verify the 
     authenticity of prescription drugs.
       (g) Definitions.--In this Act:
       (1) The term ``pedigree''--
       (A) means the history of each prior sale, purchase, or 
     trade of the prescription drug involved to a distributor or 
     retailer of the drug (including the date of the transaction 
     and the names and addresses of all parties to the 
     transaction); and
       (B) excludes information about the sale, purchase, or trade 
     of the drug to the drug consumer.
       (2) The term ``prescription drug'' means a drug subject to 
     section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 353(b)(1)).
       (3) The term ``Secretary'' means the Secretary of Health 
     and Human Services.

                                 ______
                                 
  SA 984. Mr. VITTER submitted an amendment intended to be proposed by 
him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic 
Act to reauthorize and amend the prescription drug user fee provisions, 
and for other purposes; which was ordered to lie on the table; as 
follows:

       At the appropriate place, insert the following:

                TITLE--IMPORTATION OF PRESCRIPTION DRUGS

     SEC. _01. SHORT TITLE.

       This Act may be cited as the ``Pharmaceutical Market Access 
     Act of 2007''.

     SEC. _02. FINDINGS.

       Congress finds as follows:
       (1) Americans unjustly pay up to 1,000 percent more to fill 
     their prescriptions than consumers in other countries.
       (2) The United States is the world's largest market for 
     pharmaceuticals yet consumers still pay the world's highest 
     prices.
       (3) An unaffordable drug is neither safe nor effective. 
     Allowing and structuring the importation of prescription 
     drugs ensures access to affordable drugs, thus providing a 
     level of safety to American consumers they do not currently 
     enjoy.
       (4) Prescription drug costs are a leading cause of the 
     growth in United States health care spending, which reached 
     nearly $2,000,000,0000 in 2005, of which spending on 
     prescription drugs amounted to $200,700,000,000.
       (5) According to the Congressional Budget Office, American 
     seniors alone will spend $1,800,000,000,000 on 
     pharmaceuticals over the next 10 years.
       (6) Allowing open pharmaceutical markets could save 
     American consumers at least $635,000,000,000 of their own 
     money.

     SEC. _03. PURPOSES.

       The purposes of this title are to--
       (1) give all Americans immediate relief from the 
     outrageously high cost of pharmaceuticals;
       (2) reverse the perverse economics of the American 
     pharmaceutical market;
       (3) allow the importation of prescription drugs only if the 
     drugs and facilities where such drugs are manufactured are 
     approved by the Food and Drug Administration, and to exclude 
     pharmaceutical narcotics;
       (4) ensure continued integrity to the prescription drug 
     supply of the United States by--
       (A) requiring that imported prescription drugs be packaged 
     and shipped using counterfeit-resistant technologies;
       (B) requiring Internet pharmacies to register with the 
     United States Government for Americans to verify authenticity 
     before purchases over the Internet;
       (C) requiring all foreign sellers to register with United 
     States Government and submit to facility inspections by the 
     Government without prior notice; and
       (D) limiting the eligible countries from which prescription 
     drugs may be imported to Canada, member countries of the 
     European Union, and other highly industrialized nations with 
     safe pharmaceutical infrastructures.

     SEC. _04. AMENDMENTS TO SECTION 804 OF THE FEDERAL FOOD, 
                   DRUG, AND COSMETIC ACT.

       (a) Definitions.--Section 804(a) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 384(a)) is amended to read as 
     follows:
       ``(a) Definitions.--In this section:
       ``(1) Importer.--The term `importer' means a pharmacy, 
     group of pharmacies, pharmacist, or wholesaler.
       ``(2) Permitted country.--The term `permitted country' 
     means Australia, Canada, Israel, Japan, New Zealand, 
     Switzerland, South Africa, Austria, Belgium, Denmark, 
     Finland, France, Germany, Greece, Ireland, Italy, Luxemburg, 
     Netherlands, Portugal, Spain, Sweden, the United Kingdom, 
     Iceland, Liechtenstein, and Norway, except that the 
     Secretary--
       ``(A) may add a country, union, or economic area as a 
     permitted country for purposes of this section if the 
     Secretary determines that the country, union, or economic 
     area has a pharmaceutical infrastructure that is 
     substantially equivalent or superior to the pharmaceutical 
     infrastructure of the United States, taking into 
     consideration pharmacist qualifications, pharmacy storage 
     procedures, the drug distribution system, the drug dispensing 
     system, and market regulation; and
       ``(B) may remove a country, union, or economic area as a 
     permitted country for purposes of this section if the 
     Secretary determines that the country, union, or economic 
     area does not have such a pharmaceutical infrastructure.
       ``(3) Pharmacist.--The term `pharmacist' means a person 
     licensed by the relevant governmental authority to practice 
     pharmacy, including the dispensing and selling of 
     prescription drugs.
       ``(4) Pharmacy.--The term `pharmacy' means a person that is 
     licensed by the relevant governmental authority to engage in 
     the business of selling prescription drugs that employs 1 or 
     more pharmacists.
       ``(5) Prescription drug.--The term `prescription drug' 
     means a drug subject to section 503(b), other than--
       ``(A) a controlled substance (as defined in section 102 of 
     the Controlled Substances Act (21 U.S.C. 802));
       ``(B) a biological product (as defined in section 351 of 
     the Public Health Service Act (42 U.S.C. 262));
       ``(C) an infused drug (including a peritoneal dialysis 
     solution);
       ``(D) an intravenously injected drug;
       ``(E) a drug that is inhaled during surgery; or
       ``(F) a drug which is a parenteral drug, the importation of 
     which pursuant to subsection (b) is determined by the 
     Secretary to pose a threat to the public health, in which 
     case section 801(d)(1) shall continue to apply.
       ``(6) Qualifying drug.--The term `qualifying drug' means a 
     prescription drug that--
       ``(A) is approved pursuant to an application submitted 
     under section 505(b)(1); and
       ``(B) is not--
       ``(i) a drug manufactured through 1 or more biotechnology 
     processes;
       ``(ii) a drug that is required to be refrigerated; or
       ``(iii) a photoreactive drug.
       ``(7) Qualifying internet pharmacy.--The term `qualifying 
     Internet pharmacy' means a registered exporter that dispenses 
     qualifying drugs to individuals over an Internet website.
       ``(8) Qualifying laboratory.--The term `qualifying 
     laboratory' means a laboratory in the United States that has 
     been approved by the Secretary for the purposes of this 
     section.
       ``(9) Registered exporter.--The term `registered exporter' 
     means a person that is in the business of exporting a drug to 
     persons in the United States (or that seeks to be in such 
     business), for which a registration under this section has 
     been approved and is in effect.
       ``(10) Wholesaler.--
       ``(A) In general.--The term `wholesaler' means a person 
     licensed as a wholesaler or distributor of prescription drugs 
     in the United States under section 503(e)(2)(A).

[[Page 10769]]

       ``(B) Exclusion.--The term `wholesaler' does not include a 
     person authorized to import drugs under section 801(d)(1).''.
       (b) Regulations.--Section 804(b) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 384(b)) is amended to read as 
     follows:
       ``(b) Regulations.--Not later than 180 days after the date 
     of enactment of the Pharmaceutical Market Access Act of 2007, 
     the Secretary, after consultation with the United States 
     Trade Representative and the Commissioner of the Bureau of 
     Customs and Border Protection, shall promulgate regulations 
     permitting pharmacists, pharmacies, and wholesalers to import 
     qualifying drugs from permitted countries into the United 
     States.''.
       (c) Limitation.--Section 804(c) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 384(c)) is amended by striking 
     ``prescription drug'' each place it appears and inserting 
     ``qualifying drug''.
       (d) Information and Records.--Section 804(d)(1) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384(d)(1)) is 
     amended--
       (1) by striking subparagraph (G) and redesignating 
     subparagraphs (H) through (N) as subparagraphs (G) through 
     (M), respectively;
       (2) in subparagraph (H) (as so redesignated), by striking 
     ``telephone number, and professional license number (if 
     any)'' and inserting ``and telephone number''; and
       (3) in subparagraph (L) (as so redesignated), by striking 
     ``(J) and (L)'' and inserting ``(I) and (K)''.
       (e) Testing.--Section 804(e) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 384(e)) is amended to read as 
     follows:
       ``(e) Testing.--The regulations under subsection (b) shall 
     require that the testing described under subparagraphs (I) 
     and (K) of subsection (d)(1) be conducted by the importer of 
     the qualifying drug, unless the qualifying drug is subject to 
     the requirements under section 505C for counterfeit-resistant 
     technologies.''.
       (f) Registration of Exporters; Inspections.--Section 804(f) 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     384(f)) is amended to read as follows:
       ``(f) Registration of Exporters; Inspections.--
       ``(1) In general.--Any person that seeks to be a registered 
     exporter (referred to in this subsection as the `registrant') 
     shall submit to the Secretary a registration that includes 
     the following:
       ``(A) The name of the registrant and identification of all 
     places of business of the registrant that relate to 
     qualifying drugs, including each warehouse or other facility 
     owned or controlled by, or operated for, the registrant;
       ``(B) An agreement by the registrant to--
       ``(i) make its places of business that relate to qualifying 
     drugs (including warehouses and other facilities owned or 
     controlled by, or operated for, the exporter) and records 
     available to the Secretary for on-site inspections, without 
     prior notice, for the purpose of determining whether the 
     registrant is in compliance with this Act's requirements;
       ``(ii) export only qualifying drugs;
       ``(iii) export only to persons authorized to import the 
     drugs;
       ``(iv) notify the Secretary of a recall or withdrawal of a 
     qualifying drug distributed in a permitted country to or from 
     which the registrant has exported or imported, or intends to 
     export or import, to the United States;
       ``(v) monitor compliance with registration conditions and 
     report any noncompliance promptly;
       ``(vi) submit a compliance plan showing how the registrant 
     will correct violations, if any; and
       ``(vii) promptly notify the Secretary of changes in the 
     registration information of the registrant.
       ``(2) Notice of approval or disapproval.--
       ``(A) In general.--Not later than 90 days after receiving a 
     completed registration from a registrant, the Secretary 
     shall--
       ``(i) notify such registrant of receipt of the 
     registration;
       ``(ii) assign such registrant a registration number; and
       ``(iii) approve or disapprove the application.
       ``(B) Disapproval of application.--
       ``(i) In general.--The Secretary shall disapprove a 
     registration, and notify the registrant of such disapproval, 
     if the Secretary has reason to believe that such registrant 
     is not in compliance with a registration condition.
       ``(ii) Subsequent approval.--The Secretary may subsequently 
     approve a registration that was denied under clause (i) if 
     the Secretary finds that the registrant is in compliance with 
     all registration conditions.
       ``(3) List.--The Secretary shall--
       ``(A) maintain an up-to-date list of registered exporters 
     (including qualifying Internet pharmacies that sell 
     qualifying drugs to individuals);
       ``(B) make such list available to the public on the 
     Internet site of the Food and Drug Administration and via a 
     toll-free telephone number; and
       ``(C) update such list promptly after the approval of a 
     registration under this subsection.
       ``(4) Education of consumers.--The Secretary shall carry 
     out activities, by use of the Internet website and toll-free 
     telephone number under paragraph (3), that educate consumers 
     with regard to the availability of qualifying drugs for 
     import for personal use under this section, including 
     information on how to verify whether an exporter is 
     registered.
       ``(5) Inspection of importers and registered exporters.--
     The Secretary shall inspect the warehouses, other facilities, 
     and records of importers and registered exporters as often as 
     the Secretary determines necessary to ensure that such 
     importers and registered exporters are in compliance with 
     this section.''.
       (g) Suspension of Importation.--Section 804(g) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384(g)) is 
     amended by--
       (1) striking ``and the Secretary determines that the public 
     is adequately protected from counterfeit and violative 
     prescription drugs being imported under subsection (b)''; and
       (2) by adding after the period at the end the following: 
     ``The Secretary shall reinstate the importation by a specific 
     importer upon a determination by the Secretary that the 
     violation has been corrected and that the importer has 
     demonstrated that further violations will not occur. This 
     subsection shall not apply to a prescription drug imported by 
     an individual, or to a prescription drug shipped to an 
     individual by a qualifying Internet pharmacy.''.
       (h) Waiver Authority for Individuals.--Section 804(j) of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384(j)) 
     is amended to read as follows:
       ``(j) Importation by Individuals.--
       ``(1) In general.--Not later than 180 days after the 
     enactment of the Pharmaceutical Market Access Act of 2007, 
     the Secretary shall by regulation permit an individual to 
     import a drug from a permitted country to the United States 
     if the drug is--
       ``(A) a qualifying drug;
       ``(B) imported from a licensed pharmacy or qualifying 
     Internet pharmacy;
       ``(C) for personal use by an individual, or family member 
     of the individual, not for resale;
       ``(D) in a quantity that does not exceed a 90-day supply 
     during any 90-day period; and
       ``(E) accompanied by a copy of a prescription for the drug, 
     which--
       ``(i) is valid under applicable Federal and State laws; and
       ``(ii) was issued by a practitioner who is authorized to 
     administer prescription drugs.
       ``(2) Drugs dispensed outside the united states.--An 
     individual may import a drug from a country that is not a 
     permitted country if--
       ``(A) the drug was dispensed to the individual while the 
     individual was in such country, and the drug was dispensed in 
     accordance with the laws and regulations of such country;
       ``(B) the individual is entering the United States and the 
     drug accompanies the individual at the time of entry;
       ``(C) the drug is approved for commercial distribution in 
     the country in which the drug was obtained;
       ``(D) the drug does not appear to be adulterated; and
       ``(E) the quantity of the drug does not exceed a 14-day 
     supply.''.
       (i) Repeal of Certain Provisions.--Section 804 of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384) is 
     amended by striking subsections (l) and (m).

     SEC. _05. REGISTRATION FEES.

       Subchapter C of chapter VII of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 397f et seq.) is amended by adding at 
     the end the following:

        ``PART 5--FEES RELATING TO PRESCRIPTION DRUG IMPORTATION

     ``SEC. 740A. FEES RELATING TO PRESCRIPTION DRUG IMPORTATION.

       ``(a) Registration Fee.--The Secretary shall establish a 
     registration fee program under which a registered exporter 
     under section 804 shall be required to pay an annual fee to 
     the Secretary in accordance with this subsection.
       ``(b) Collection.--
       ``(1) Collection on initial registration.--A fee under this 
     section shall be payable for the fiscal year in which the 
     registered exporter first submits a registration under 
     section 804 (or reregisters under that section if that person 
     has withdrawn its registration and subsequently reregisters) 
     in a amount of $10,000, due on the date the exporter first 
     submits a registration to the Secretary under section 804.
       ``(2) Collection in subsequent years.--After the fee is 
     paid for the first fiscal year, the fee described under this 
     subsection shall be payable on or before October 1 of each 
     year.
       ``(3) One fee per facility.--The fee shall be paid only 
     once for each registered exporter for a fiscal year in which 
     the fee is payable.
       ``(c) Fee Amount.--
       ``(1) In general.--Subject to subsection (b)(1), the amount 
     of the fee shall be determined each year by the Secretary and 
     shall be based on the anticipated costs to the Secretary of 
     enforcing the amendments made by the Pharmaceutical Market 
     Access Act of 2007 in the subsequent fiscal year.
       ``(2) Limitation.--

[[Page 10770]]

       ``(A) In general.--The aggregate total of fees collected 
     under this section shall not exceed 1 percent of the total 
     price of drugs exported annually to the United States by 
     registered exporters under this section.
       ``(B) Reasonable estimate.--Subject to the limitation 
     described in subparagraph (A), a fee under this subsection 
     for an exporter shall be an amount that is a reasonable 
     estimate by the Secretary of the annual share of the exporter 
     of the volume of drugs exported by exporters under this 
     section.
       ``(d) Use of Fees.--The fees collected under this section 
     shall be used for the sole purpose of administering this 
     section with respect to registered exporters, including the 
     costs associated with--
       ``(1) inspecting the facilities of registered exporters, 
     and of other entities in the chain of custody of a qualifying 
     drug;
       ``(2) developing, implementing, and maintaining a system to 
     determine registered exporters' compliance with the 
     registration conditions under the Pharmaceutical Market 
     Access Act of 2007, including when shipments of qualifying 
     drugs are offered for import into the United States; and
       ``(3) inspecting such shipments, as necessary, when offered 
     for import into the United States to determine if any such 
     shipment should be refused admission.
       ``(e) Annual Fee Setting.--The Secretary shall establish, 
     60 days before the beginning of each fiscal year beginning 
     after September 30, 2007, for that fiscal year, registration 
     fees.
       ``(f) Effect of Failure to Pay Fees.--
       ``(1) Due date.--A fee payable under this section shall be 
     paid by the date that is 30 days after the date on which the 
     fee is due.
       ``(2) Failure to pay.--If a registered exporter subject to 
     a fee under this section fails to pay the fee, the Secretary 
     shall not permit the registered exporter to engage in 
     exportation to the United States or offering for exportation 
     prescription drugs under this Act until all such fees owed by 
     that person are paid.
       ``(g) Reports.--
       ``(1) Fee establishment.--Not later than 60 days before the 
     beginning of each fiscal year, the Secretary shall--
       ``(A) publish registration fees under this section for that 
     fiscal year;
       ``(B) hold a meeting at which the public may comment on the 
     recommendations; and
       ``(C) provide for a period of 30 days for the public to 
     provide written comments on the recommendations.
       ``(2) Performance and fiscal report.--Beginning with fiscal 
     year 2007, not later than 60 days after the end of each 
     fiscal year during which fees are collected under this 
     section, the Secretary shall submit to the Committee on 
     Health, Education, Labor, and Pensions of the Senate and the 
     Committee on Energy and Commerce of the House of 
     Representatives a report that describes--
       ``(A) implementation of the registration fee authority 
     during the fiscal year; and
       ``(B) the use by the Secretary of the fees collected during 
     the fiscal year for which the report is made.''.

     SEC. _06. COUNTERFEIT-RESISTANT TECHNOLOGY.

       (a) Misbranding.--Section 502 of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 352; deeming drugs and devices to 
     be misbranded) is amended by adding at the end the following:
       ``(z) If it is a drug subject to section 503(b), unless the 
     packaging of such drug complies with the requirements of 
     section 505C for counterfeit-resistant technologies.''.
       (b) Requirements.--Chapter V of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting 
     after section 505B the following:

     ``SEC. 505C. COUNTERFEIT-RESISTANT TECHNOLOGIES.

       ``(a) Incorporation of Counterfeit-Resistant Technologies 
     Into Prescription Drug Packaging.--The Secretary shall 
     require that the packaging of any drug subject to section 
     503(b) incorporate--
       ``(1) overt optically variable counterfeit-resistant 
     technologies that are described in subsection (b) and comply 
     with the standards of subsection (c); or
       ``(2) technologies that have an equivalent function of 
     security, as determined by the Secretary.
       ``(b) Eligible Technologies.--Technologies described in 
     this subsection--
       ``(1) shall be visible to the naked eye, providing for 
     visual identification of product authenticity without the 
     need for readers, microscopes, lighting devices, or scanners;
       ``(2) shall be similar to that used by the Bureau of 
     Engraving and Printing to secure United States currency;
       ``(3) shall be manufactured and distributed in a highly 
     secure, tightly controlled environment; and
       ``(4) should incorporate additional layers of non-visible 
     covert security features up to and including forensic 
     capability.
       ``(c) Standards for Packaging.--
       ``(1) Multiple elements.--For the purpose of making it more 
     difficult to counterfeit the packaging of drugs subject to 
     section 503(b), manufacturers of the drugs shall incorporate 
     the technologies described in subsection (b) into multiple 
     elements of the physical packaging of the drugs, including 
     blister packs, shrink wrap, package labels, package seals, 
     bottles, and boxes.
       ``(2) Labeling of shipping container.--Shipments of drugs 
     described in subsection (a) shall include a label on the 
     shipping container that incorporates the technologies 
     described in subsection (b), so that officials inspecting the 
     packages will be able to determine the authenticity of the 
     shipment. Chain of custody procedures shall apply to such 
     labels and shall include procedures applicable to contractual 
     agreements for the use and distribution of the labels, 
     methods to audit the use of the labels, and database access 
     for the relevant governmental agencies for audit or 
     verification of the use and distribution of the labels.
       ``(d) Effective Date.--This section shall take effect 180 
     days after the date of enactment of the Pharmaceutical Market 
     Access Act of 2007.''.

     SEC. _07. PROHIBITED ACTS.

       Section 301 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 331) is amended by inserting after subsection (k) the 
     following:
       ``(l) The failure to register in accordance with section 
     804(f) or to import or offer to import a prescription drug in 
     violation of a suspension order under section 804(g).''.

     SEC. _08. PATENTS.

       Section 271 of title 35, United States Code, is amended--
       (1) by redesignating subsections (h) and (i) as subsections 
     (i) and (j), respectively; and
       (2) by inserting after subsection (g) the following:
       ``(h) It shall not be an act of infringement to use, offer 
     to sell, or sell within the United States or to import into 
     the United States any patented invention under section 804 
     (21 U.S.C. 384) of the Federal Food, Drug, and Cosmetic Act 
     that was first sold abroad by or under authority of the owner 
     or licensee of such patent.''.

     SEC. _09. OTHER ENFORCEMENT ACTIONS.

       (a) In General.--Section 804 of the Federal Food, Drug, and 
     Cosmetic Act (as amended in section _04) is amended by adding 
     at the end the following:
       ``(l) Unfair or Discriminatory Acts and Practices.--
       ``(1) In general.--It is unlawful for a manufacturer, 
     directly or indirectly (including by being a party to a 
     licensing or other agreement) to--
       ``(A) discriminate by charging a higher price for a 
     prescription drug sold to a person in a permitted country 
     that exports a prescription drug to the United States under 
     this section than the price that is charged to another person 
     that is in the same country and that does not export a 
     prescription drug into the United States under this section;
       ``(B) discriminate by charging a higher price for a 
     prescription drug sold to a person that distributes, sells, 
     or uses a prescription drug imported into the United States 
     under this section than the price that is charged to another 
     person in the United States that does not import a 
     prescription drug under this section, or that does not 
     distribute, sell, or use such a drug;
       ``(C) discriminate by denying supplies of a prescription 
     drug to a person in a permitted country that exports a 
     prescription drug to the United States under this section or 
     distributes, sells, or uses a prescription drug imported into 
     the United States under this section;
       ``(D) discriminate by publicly, privately, or otherwise 
     refusing to do business with a person in a permitted country 
     that exports a prescription drug to the United States under 
     this section or distributes, sells, or uses a prescription 
     drug imported into the United States under this section;
       ``(E) discriminate by specifically restricting or delaying 
     the supply of a prescription drug to a person in a permitted 
     country that exports a prescription drug to the United States 
     under this section or distributes, sells, or uses a 
     prescription drug imported into the United States under this 
     section;
       ``(F) cause there to be a difference (including a 
     difference in active ingredient, route of administration, 
     dosage form, strength, formulation, manufacturing 
     establishment, manufacturing process, or person that 
     manufactures the drug) between a prescription drug for 
     distribution in the United States and the drug for 
     distribution in a permitted country for the purpose of 
     restricting importation of the drug into the United States 
     under this section;
       ``(G) refuse to allow an inspection authorized under this 
     section of an establishment that manufactures a prescription 
     drug that may be imported or offered for import under this 
     section;
       ``(H) fail to conform to the methods used in, or the 
     facilities used for, the manufacturing, processing, packing, 
     or holding of a prescription drug that may be imported or 
     offered for import under this section to good manufacturing 
     practice under this Act;
       ``(I) become a party to a licensing or other agreement 
     related to a prescription drug that fails to provide for 
     compliance with all requirements of this section with respect 
     to such prescription drug or that has the effect of 
     prohibiting importation of the drug under this section; or
       ``(J) engage in any other action that the Federal Trade 
     Commission determines to discriminate against a person that 
     engages in, or to impede, delay, or block the process for, 
     the importation of a prescription drug under this section.

[[Page 10771]]

       ``(2) Affirmative defense.--It shall be an affirmative 
     defense to a charge that a person has discriminated under 
     subparagraph (A), (B), (C), (D), or (E) of paragraph (1) that 
     the higher price charged for a prescription drug sold to a 
     person, the denial of supplies of a prescription drug to a 
     person, the refusal to do business with a person, or the 
     specific restriction or delay of supplies to a person is not 
     based, in whole or in part, on--
       ``(A) the person exporting or importing a prescription drug 
     into the United States under this section; or
       ``(B) the person distributing, selling, or using a 
     prescription drug imported into the United States under this 
     section.
       ``(3) Presumption and affirmative defense.--
       ``(A) Presumption.--A difference (including a difference in 
     active ingredient, route of administration, dosage form, 
     strength, formulation, manufacturing establishment, 
     manufacturing process, or person that manufactures the drug) 
     created after January 1, 2007, between a prescription drug 
     for distribution in the United States and the drug for 
     distribution in a permitted country shall be presumed under 
     paragraph (1)(H) to be for the purpose of restricting 
     importation of the drug into the United States under this 
     section.
       ``(B) Affirmative defense.--It shall be an affirmative 
     defense to the presumption under subparagraph (A) that--
       ``(i) the difference was required by the country in which 
     the drug is distributed; or
       ``(ii) the Secretary has determined that the difference was 
     necessary to improve the safety or effectiveness of the drug.
       ``(4) Effect of subsection.--
       ``(A) Sales in other countries.--This subsection applies 
     only to the sale or distribution of a prescription drug in a 
     country if the manufacturer of the drug chooses to sell or 
     distribute the drug in the country. Nothing in this 
     subsection shall be construed to compel the manufacturer of a 
     drug to distribute or sell the drug in a country.
       ``(B) Discounts to insurers, health plans, pharmacy benefit 
     managers, and covered entities.--Nothing in this subsection 
     shall be construed to--
       ``(i) prevent or restrict a manufacturer of a prescription 
     drug from providing discounts to an insurer, health plan, 
     pharmacy benefit manager in the United States, or covered 
     entity in the drug discount program under section 340B in 
     return for inclusion of the drug on a formulary;
       ``(ii) require that such discounts be made available to 
     other purchasers of the prescription drug; or
       ``(iii) prevent or restrict any other measures taken by an 
     insurer, health plan, or pharmacy benefit manager to 
     encourage consumption of such prescription drug.
       ``(C) Charitable contributions.--Nothing in this subsection 
     shall be construed to--
       ``(i) prevent a manufacturer from donating a prescription 
     drug, or supplying a prescription drug at nominal cost, to a 
     charitable or humanitarian organization, including the United 
     Nations and affiliates, or to a government of a foreign 
     country; or
       ``(ii) apply to such donations or supplying of a 
     prescription drug.
       ``(5) Enforcement.--
       ``(A) Unfair or deceptive act or practice.--A violation of 
     this subsection shall be treated as a violation of a rule 
     defining an unfair or deceptive act or practice prescribed 
     under section 18(a)(1)(B) of the Federal Trade Commission 
     Act.
       ``(B) Actions by the commission.--The Federal Trade 
     Commission--
       ``(i) shall enforce this subsection in the same manner, by 
     the same means, and with the same jurisdiction, powers, and 
     duties as though all applicable terms and provisions of the 
     Federal Trade Commission Act were incorporated into and made 
     a part of this section; and
       ``(ii) may seek monetary relief threefold the damages 
     sustained.
       ``(6) Actions by states.--
       ``(A) In general.--
       ``(i) Civil actions.--The attorney general of a State may 
     bring a civil action on behalf of the residents of the State, 
     and persons doing business in the State, in a district court 
     of the United States of appropriate jurisdiction for a 
     violation of paragraph (1) to--

       ``(I) enjoin that practice;
       ``(II) enforce compliance with this subsection;
       ``(III) obtain damages, restitution, or other compensation 
     on behalf of residents of the State and persons doing 
     business in the State, including threefold the damages; or
       ``(IV) obtain such other relief as the court may consider 
     to be appropriate.

       ``(ii) Notice.--

       ``(I) In general.--Before filing an action under clause 
     (i), the attorney general of the State involved shall provide 
     to the Federal Trade Commission--

       ``(aa) written notice of that action; and
       ``(bb) a copy of the complaint for that action.

       ``(II) Exemption.--Subclause (I) shall not apply with 
     respect to the filing of an action by an attorney general of 
     a State under this paragraph, if the attorney general 
     determines that it is not feasible to provide the notice 
     described in that subclause before filing of the action. In 
     such case, the attorney general of a State shall provide 
     notice and a copy of the complaint to the Federal Trade 
     Commission at the same time as the attorney general files the 
     action.

       ``(B) Intervention.--
       ``(i) In general.--On receiving notice under subparagraph 
     (A)(ii), the Commission shall have the right to intervene in 
     the action that is the subject of the notice.
       ``(ii) Effect of intervention.--If the Commission 
     intervenes in an action under subparagraph (A), it shall have 
     the right--

       ``(I) to be heard with respect to any matter that arises in 
     that action; and
       ``(II) to file a petition for appeal.

       ``(C) Construction.--For purposes of bringing any civil 
     action under subparagraph (A), nothing in this subsection 
     shall be construed to prevent an attorney general of a State 
     from exercising the powers conferred on the attorney general 
     by the laws of that State to--
       ``(i) conduct investigations;
       ``(ii) administer oaths or affirmations; or
       ``(iii) compel the attendance of witnesses or the 
     production of documentary and other evidence.
       ``(D) Actions by the commission.--
       ``(i) In general.--In any case in which an action is 
     instituted by or on behalf of the Commission for a violation 
     of paragraph (1), a State may not, during the pendency of 
     that action, institute an action under subparagraph (A) for 
     the same violation against any defendant named in the 
     complaint in that action.
       ``(ii) Intervention.--An attorney general of a State may 
     intervene, on behalf of the residents of that State, in an 
     action instituted by the Commission.
       ``(iii) Effect of intervention.--If an attorney general of 
     a State intervenes in an action instituted by the Commission, 
     such attorney general shall have the right--

       ``(I) to be heard with respect to any matter that arises in 
     that action; and
       ``(II) to file a petition for appeal.

       ``(E) Venue.--Any action brought under subparagraph (A) may 
     be brought in the district court of the United States that 
     meets applicable requirements relating to venue under section 
     1391 of title 28, United States Code.
       ``(F) Service of process.--In an action brought under 
     subparagraph (A), process may be served in any district in 
     which the defendant--
       ``(i) is an inhabitant; or
       ``(ii) may be found.
       ``(G) Limitation of actions.--Any action under this 
     paragraph to enforce a cause of action under this subsection 
     by the Federal Trade Commission or the attorney general of a 
     State shall be forever barred unless commenced within 5 years 
     after the Federal Trade Commission, or the attorney general, 
     as the case may be, knew or should have known that the cause 
     of action accrued. No cause of action barred under existing 
     law on the effective date of the Pharmaceutical Market Access 
     Act of 2007 shall be revived by such Act.
       ``(H) Measurement of damages.--In any action under this 
     paragraph to enforce a cause of action under this subsection 
     in which there has been a determination that a defendant has 
     violated a provision of this subsection, damages may be 
     proved and assessed in the aggregate by statistical or 
     sampling methods, by the computation of illegal overcharges 
     or by such other reasonable system of estimating aggregate 
     damages as the court in its discretion may permit without the 
     necessity of separately proving the individual claim of, or 
     amount of damage to, persons on whose behalf the suit was 
     brought.
       ``(I) Exclusion on duplicative relief.--The district court 
     shall exclude from the amount of monetary relief awarded in 
     an action under this paragraph brought by the attorney 
     general of a State any amount of monetary relief which 
     duplicates amounts which have been awarded for the same 
     injury.
       ``(7) Effect on antitrust laws.--Nothing in this subsection 
     shall be construed to modify, impair, or supersede the 
     operation of the antitrust laws. For the purpose of this 
     subsection, the term `antitrust laws' has the meaning given 
     it in the first section of the Clayton Act, except that it 
     includes section 5 of the Federal Trade Commission Act to the 
     extent that such section 5 applies to unfair methods of 
     competition.
       ``(8) Manufacturer.--In this subsection, the term 
     `manufacturer' means any entity, including any affiliate or 
     licensee of that entity, that is engaged in--
       ``(A) the production, preparation, propagation, 
     compounding, conversion, or processing of a prescription 
     drug, either directly or indirectly by extraction from 
     substances of natural origin, or independently by means of 
     chemical synthesis, or by a combination of extraction and 
     chemical synthesis; or
       ``(B) the packaging, repackaging, labeling, relabeling, or 
     distribution of a prescription drug.''.
       (b) Regulations.--The Federal Trade Commission shall 
     promulgate regulations to carry out the enforcement program 
     under section 804(l) of the Federal Food, Drug, and Cosmetic 
     Act (as added by subsection (a)).
       (c) Suspension and Termination of Exporters.--Section 
     804(g) of the Federal Food, Drug, and Cosmetic Act (as 
     amended

[[Page 10772]]

     by section _04(g)) (21 U.S.C. 384(g)) is amended by--
       (1) striking ``Suspension of Importation.--The Secretary'' 
     and inserting ``Suspension of Importation.--
       ``(1) In general.--The Secretary''; and
       (2) adding at the end the following:
       ``(2) Suspension and termination of exporters.--
       ``(A) Suspension.--With respect to the effectiveness of a 
     registration submitted under subsection (f) by a registered 
     exporter:
       ``(i) Subject to clause (ii), if the Secretary determines, 
     after notice and opportunity for a hearing, that the 
     registered exporter has failed to maintain substantial 
     compliance with all registration conditions, the Secretary 
     may suspend the registration.
       ``(ii) If the Secretary determines that, under color of the 
     registration, the registered exporter has exported a drug 
     that is not a qualifying drug, or a drug that does not meet 
     the criteria under this section, or has exported a qualifying 
     drug to an individual in violation of this section, the 
     Secretary shall immediately suspend the registration. A 
     suspension under the preceding sentence is not subject to the 
     provision by the Secretary of prior notice, and the Secretary 
     shall provide to the registered exporter involved an 
     opportunity for a hearing not later than 10 days after the 
     date on which the registration is suspended.
       ``(iii) The Secretary may reinstate the registration, 
     whether suspended under clause (i) or (ii), if the Secretary 
     determines that the registered exporter has demonstrated that 
     further violations of registration conditions will not occur.
       ``(B) Termination.--The Secretary, after notice and 
     opportunity for a hearing, may terminate the registration 
     under subsection (f) of a registered exporter if the 
     Secretary determines that the registered exporter has engaged 
     in a pattern or practice of violating 1 or more registration 
     conditions, or if on 1 or more occasions the Secretary has 
     under subparagraph (A)(ii) suspended the registration of the 
     registered exporter. The Secretary may make the termination 
     permanent, or for a fixed period of not less than 1 year. 
     During the period in which the registration of a registered 
     exporter is terminated, any registration submitted under 
     subsection (f) by such exporter or a person who is a partner 
     in the export enterprise or a principal officer in such 
     enterprise, and any registration prepared with the assistance 
     of such exporter or such a person, has no legal effect under 
     this section.''.

     SEC. _10. AUTHORIZATION OF APPROPRIATIONS.

       There are authorized to be appropriated such sums as may be 
     necessary to carry out this title (and the amendments made by 
     this title).

                                 ______
                                 
  SA 985. Mr. BROWNBACK (for himself and Mr. Brown) submitted an 
amendment intended to be proposed by him to the bill S. 1082, to amend 
the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the 
prescription drug user fee provisions, and for other purposes; which 
was ordered to lie on the table; as follows:

       At the appropriate place, insert the following:

     SEC. __. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR TROPICAL 
                   DISEASES.

       Subchapter A of chapter V of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at 
     the end the following:

     ``SEC. 524. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR 
                   TROPICAL DISEASES.

       ``(a) Definitions.--In this section:
       ``(1) AIDS.--The term `AIDS' means the acquired immune 
     deficiency syndrome.
       ``(2) AIDS drug.--The term `AIDS drug' means a drug 
     indicated for treating HIV.
       ``(3) HIV.--The term `HIV' means the human immunodeficiency 
     virus, the pathogen that causes AIDS.
       ``(4) Neglected or tropical disease.--The term `neglected 
     or tropical disease' means--
       ``(A) HIV, malaria, tuberculosis, and related diseases; or
       ``(B) any other infectious disease that disproportionately 
     affects poor and marginalized populations, including those 
     diseases targeted by the Special Programme for Research and 
     Training in Tropical Diseases cosponsored by the United 
     Nations Development Program, UNICEF, the World Bank, and the 
     World Health Organization.
       ``(5) Priority review.--The term `priority review', with 
     respect to a new drug application described in paragraph (6), 
     means review and action by the Secretary on such application 
     not later than 180 days after receipt by the Secretary of 
     such application, pursuant to the Manual of Policies and 
     Procedures of the Food and Drug Administration.
       ``(6) Priority review voucher.--The term `priority review 
     voucher' means a voucher issued by the Secretary to the 
     sponsor of a tropical disease product that entitles such 
     sponsor, or a person described under subsection (b)(2), to 
     priority review of a new drug application submitted under 
     section 505(b)(1) after the date of approval of the tropical 
     disease product.
       ``(7) Tropical disease product.--The term `tropical disease 
     product' means a product that--
       ``(A) is a new drug, antibiotic drug, biological product, 
     vaccine, device, diagnostic, or other tool for treatment of a 
     neglected or tropical disease; and
       ``(B) is approved by the Secretary for use in the treatment 
     of a neglected or tropical disease.
       ``(b) Priority Review Voucher.--
       ``(1) In general.--The Secretary shall award a priority 
     review voucher to the sponsor of a tropical disease product 
     upon approval by the Secretary of such tropical disease 
     product.
       ``(2) Transferability.--The sponsor of a tropical disease 
     product that receives a priority review voucher under this 
     section may transfer (including by sale) the entitlement to 
     such voucher to a sponsor of a new drug for which an 
     application under section 505(b)(1) will be submitted after 
     the date of the approval of the tropical disease product.
       ``(3) Limitation.--A sponsor of a tropical disease product 
     may not receive a priority review voucher under this section 
     if the tropical disease product was approved by the Secretary 
     prior to the date of enactment of this section.
       ``(c) Priority Review User Fee.--
       ``(1) In general.--The Secretary shall establish a user fee 
     program under which a sponsor of a drug that is the subject 
     of a priority review voucher shall pay to the Secretary a fee 
     determined under paragraph (2). Such fee shall be in addition 
     to any fee required to be submitted by the sponsor under 
     chapter VII.
       ``(2) Fee amount.--The amount of the priority review user 
     fee shall be determined each fiscal year by the Secretary and 
     based on the anticipated costs to the Secretary of 
     implementing this section.
       ``(3) Annual fee setting.--The Secretary shall establish, 
     before the beginning of each fiscal year beginning after 
     September 30, 2007, for that fiscal year, the amount of the 
     priority review user fee.
       ``(4) Payment.--
       ``(A) In general.--The fee required by this subsection 
     shall be due upon the filing of the new drug application 
     under section 505(b)(1) for which the voucher is used.
       ``(B) Complete application.--An application described under 
     subparagraph (A) for which the sponsor requests the use of a 
     priority review voucher shall be considered incomplete if the 
     fee required by this subsection is not included in such 
     application.''.
                                 ______
                                 
  SA 986. Ms. LANDRIEU submitted an amendment intended to be proposed 
by her to the bill S. 1082, to amend the Federal Food, Drug, and 
Cosmetic Act to reauthorize and amend the prescription drug user fee 
provisions, and for other purposes; which was ordered to lie on the 
table; as follows:

       At the end of the bill, add the following:

                TITLE--DOMESTIC PET TURTLE MARKET ACCESS

     SEC. __. SHORT TITLE.

       This title may be cited as the ``Domestic Pet Turtle Market 
     Access Act of 2007''.

     SEC. __. FINDINGS.

       Congress makes the following findings:
       (1) Pet turtles less than 10.2 centimeters in diameter have 
     been banned for sale in the United States by the Food and 
     Drug Administration since 1975 due to health concerns.
       (2) The Food and Drug Administration does not ban the sale 
     of iguanas or other lizards, snakes, frogs, or other 
     amphibians or reptiles that are sold as pets in the United 
     States that also carry salmonella bacteria. The Food and Drug 
     Administration also does not require that these animals be 
     treated for salmonella bacteria before being sold as pets.
       (3) The technology to treat turtles for salmonella, and 
     make them safe for sale, has greatly advanced since 1975. 
     Treatments exist that can nearly eradicate salmonella from 
     turtles, and individuals are more aware of the causes of 
     salmonella, how to treat salmonella poisoning, and the 
     seriousness associated with salmonella poisoning.
       (4) University research has shown that these turtles can be 
     treated in such a way that they can be raised, shipped, and 
     distributed without having a recolonization of salmonella.
       (5) University research has also shown that pet owners can 
     be equipped with a treatment regiment that allows the turtle 
     to be maintained safe from salmonella.
       (6) The Food and Drug Administration should allow the sale 
     of turtles less than 10.2 centimeters in diameter as pets as 
     long as the sellers are required to use proven methods to 
     treat the turtles for salmonella and maintain a safe pet.

     SEC. __. SALE OF BABY TURTLES.

       (a) In General.--Notwithstanding any other provision of 
     law, the Food and Drug Administration shall not restrict the 
     sale by a turtle farmer or other commercial retail seller of 
     a turtle that is less than 10.2 centimeters in diameter as a 
     pet if--
       (1) the turtle is raised, shipped, and sold using methods 
     that are proven to keep the turtle free of salmonella, using 
     salmonella safety standards that are comparable to such 
     standards relating to other animals, including reptiles and 
     amphibians, that are allowed for sale as pets, or animal 
     products that are allowed for sale as food products;

[[Page 10773]]

       (2) the Administration has approved a plan submitted by the 
     turtle farmer or commercial retail seller involved relating 
     to compliance with paragraph (1); and
       (3) the farmer or other commercial retail seller includes, 
     with the sale of such a turtle, a disclosure to the buyer 
     that includes--
       (A) information regarding--
       (i) the dangers, including possible severe illness or 
     death, especially for at-risk people who may be susceptible 
     to salmonella poisoning, such as children, pregnant women, 
     and others who may have weak immune systems, that could 
     result if the turtle is not properly handled and safely 
     maintained;
       (ii) the proper handling of the turtle, including an 
     explanation of proper hygiene such as handwashing after 
     handling a turtle; and
       (iii) the proven methods of treatment that, if properly 
     applied, keep the turtle safe from salmonella;
       (B) a detailed explanation of how to properly treat the 
     turtle to keep it safe from salmonella, using the proven 
     methods of treatment referred to under subparagraph (A), and 
     how the buyer can continue to purchase the tools, treatments, 
     or any other required item to continually treat the turtle; 
     and
       (C) a statement that buyers of pet turtles should not 
     abandon the turtle or abandon it outside, as the turtle may 
     become an invasive species to the local community, but should 
     instead return them to a commercial retail pet seller or 
     other organization that would accept turtles no longer wanted 
     as pets.
       (b) Plan.--
       (1) In general.--A turtle farmer or other commercial seller 
     that desires to sell a turtle as provided for under 
     subsection (a) shall submit a plan to the Food and Drug 
     Administration that details the manner in which the farmer or 
     seller will ensure compliance with the requirements of 
     subsection (a)(1) with respect to the turtles involved. The 
     plan shall include use of non-antibiotic compounds that 
     suppress or eliminate the presence of salmonella in turtle 
     hatchlings.
       (2) Action by fda.--Not later 30 days after the date on 
     which the Food and Drug Administration receives a plan under 
     paragraph (1), the Administration shall accept or reject such 
     plan. If such plan is rejected, the Administration shall 
     provide clear, specific guidance on the reasons for such 
     rejection. The Administration may only reject such a plan if 
     it is determined that the plan fails to achieve the same 
     salmonella safety standards as such standards relating to 
     other animals, including reptiles and amphibians, that are 
     allowed for sale as pets, or animal products that are allowed 
     for sale as food products.
       (c) Rule of Construction.--Nothing in this section shall be 
     construed to permit the Food and Drug Administration to hold 
     the sale of turtles less than 10.2 centimeters in diameter as 
     a pet to any greater salmonella safety standard applicable to 
     other reptiles or amphibians sold as pets, animals sold as 
     pets, or food products regulated by such Administration.
                                 ______
                                 
  SA 987. Mr. INHOFE submitted an amendment intended to be proposed by 
him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic 
Act to reauthorize and amend the prescription drug user fee provisions, 
and for other purposes; which was ordered to lie on the table; as 
follows:

       At the appropriate place, insert the following:

     SEC. __. HEAD START ACT AMENDMENT IMPOSING PARENTAL CONSENT 
                   REQUIREMENT FOR NONEMERGENCY INTRUSIVE PHYSICAL 
                   EXAMINATIONS.

       The Head Start Act (42 U.S.C. 9831 et seq.) is amended by 
     adding at the end the following:

     ``SEC. 657A. PARENTAL CONSENT REQUIREMENT FOR NONEMERGENCY 
                   INTRUSIVE PHYSICAL EXAMINATIONS.

       ``(a) In General.--A Head Start agency shall obtain written 
     parental consent before administration of any nonemergency 
     intrusive physical examination of a child in connection with 
     participation in a program under this subchapter.
       ``(b) Definition.--The term `nonemergency intrusive 
     physical examination' means, with respect to a child, a 
     physical examination that--
       ``(1) is not immediately necessary to protect the health or 
     safety of the child involved or the health or safety of 
     another individual; and
       ``(2) requires incision or is otherwise invasive, or 
     involves exposure of private body parts.''.
                                 ______
                                 
  SA 988. Mr. INHOFE submitted an amendment intended to be proposed by 
him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic 
Act to reauthorize and amend the prescription drug user fee provisions, 
and for other purposes; which was ordered to lie on the table; as 
follows:

       At the appropriate place, insert the following:

     SEC. __. CHILD MEDICATION SAFETY.

       (a) Required Policies and Procedures.--
       (1) In general.--As a condition of receiving funds under 
     any program or activity administered by the Secretary of 
     Education, not later than 1 year after the date of enactment 
     of this section, each State shall develop and implement 
     policies and procedures prohibiting school personnel from 
     requiring a child to obtain a prescription for substances 
     covered by section 202(c) of the Controlled Substances Act 
     (21 U.S.C. 812(c)) or a psychotropic drug as a condition of 
     attending school or receiving services.
       (2) Rule of construction.--Nothing in paragraph (1) shall 
     be construed to create a Federal prohibition against teachers 
     and other school personnel consulting or sharing classroom-
     based observations with parents or guardians regarding a 
     student's academic performance or behavior in the classroom 
     or school, or regarding the need for evaluation for special 
     education or related services under section 612(a)(3) of the 
     Individuals with Disabilities Education Act (20 U.S.C. 
     1412(a)(3)).
       (3) Prohibition of payment of funds.--No Federal education 
     funds may be paid to any local educational agency or other 
     instrument of government that uses the refusal of a parent or 
     legal guardian to provide a substance covered by section 
     202(c) of the Controlled Substances Act (21 U.S.C. 812(c)) or 
     a psychotropic drug for such individual's child as the basis 
     of a charge of child abuse, child neglect, education neglect, 
     or medical neglect until the agency or instrument 
     demonstrates that it is no longer using such refusal as a 
     basis of a child abuse, child neglect, education neglect, or 
     medical neglect charge.
       (b) Definitions.--In this section:
       (1) Child.--The term ``child'' means any person within the 
     age limits for which the State provides free public 
     education.
       (2) Psychotropic drug.--The term ``psychotropic drug'' 
     means a drug subject to section 505 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 355) that is not a 
     substance covered by section 202(c) of the Controlled 
     Substances Act (21 U.S.C. 812(c)) but is--
       (A) used in the diagnosis, treatment, or prevention of a 
     disease; and
       (B) intended to have an altering effect on perception, 
     emotion, or behavior.
       (3) State.--The term ``State'' means each of the 50 States, 
     the District of Columbia, and the Commonwealth of Puerto 
     Rico.
       (c) GAO Study and Review.--
       (1) Review.--The Comptroller General of the United States 
     shall conduct a review of--
       (A) the variation among States in definitions of 
     psychotropic medications as used in regard to State 
     jurisdiction over public education;
       (B) the prescription rates of medications used in public 
     schools to treat children diagnosed with attention deficit 
     disorder, attention deficit hyperactivity disorder, and other 
     disorders or illnesses;
       (C) which medications used to treat such children in public 
     schools are listed under the Controlled Substances Act; and
       (D) which medications used to treat such children in public 
     schools are not listed under the Controlled Substances Act, 
     including the properties and effects of any such medications, 
     including the incidence of hallucinations, psychosis, 
     violence, suicide, heart problems, significant weight gain, 
     or diabetes that students may experience while on these 
     medications.
       (2) Report.--Not later than 1 year after the date of 
     enactment of this section, the Comptroller General of the 
     United States shall prepare and submit a report that contains 
     the results of the review under paragraph (1).
                                 ______
                                 
  SA 989. Mr. HARKIN submitted an amendment intended to be proposed by 
him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic 
Act to reauthorize and amend the prescription drug user fee provisions, 
and for other purposes; which was ordered to lie on the table; as 
follows:

       At the appropriate place, insert the following:

     SEC. __. REQUIRED INFORMATION IN DIRECT-TO-CONSUMER 
                   TELEVISION AND RADIO ADVERTISEMENTS.

       Section 502(n) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 352(n)) is amended by inserting after the first 
     sentence the following: ``In addition to the requirements 
     under the preceding sentence, in the case of an advertisement 
     of a prescription drug presented directly to consumers in 
     television or radio format that states the name of the drug 
     and its medical indications, unless the audio portion of such 
     advertisement includes a listing of all information in full 
     about adverse reactions, contraindications, and precautions 
     listed in the patient or professional labeling of the drug 
     approved under this Act.''.
                                 ______
                                 
  SA 990. Mr. DORGAN (for himself, Ms. Snowe, Mr. Grassley, Mr. McCain, 
Ms. Stabenow, Mr. Nelson of Florida, Mr. Pryor, Mr. Sanders, Mr. 
Whitehouse, and Mrs. McCaskill) submitted an amendment intended to be 
proposed by him to the bill S. 1082, to amend the Federal Food, Drug, 
and

[[Page 10774]]

Cosmetic Act to reauthorize and amend the prescription drug user fee 
provisions, and for other purposes; as follows:

       At the appropriate place, insert the following:

              TITLE __--IMPORTATION OF PRESCRIPTION DRUGS

     SEC. _01. SHORT TITLE.

       This title may be cited as the ``Pharmaceutical Market 
     Access and Drug Safety Act of 2007''.

     SEC. _02. FINDINGS.

       Congress finds that--
       (1) Americans unjustly pay up to 5 times more to fill their 
     prescriptions than consumers in other countries;
       (2) the United States is the largest market for 
     pharmaceuticals in the world, yet American consumers pay the 
     highest prices for brand pharmaceuticals in the world;
       (3) a prescription drug is neither safe nor effective to an 
     individual who cannot afford it;
       (4) allowing and structuring the importation of 
     prescription drugs to ensure access to safe and affordable 
     drugs approved by the Food and Drug Administration will 
     provide a level of safety to American consumers that they do 
     not currently enjoy;
       (5) American spend more than $200,000,000,000 on 
     prescription drugs every year;
       (6) the Congressional Budget Office has found that the cost 
     of prescription drugs are between 35 to 55 percent less in 
     other highly-developed countries than in the United States; 
     and
       (7) promoting competitive market pricing would both 
     contribute to health care savings and allow greater access to 
     therapy, improving health and saving lives.

     SEC. _03. REPEAL OF CERTAIN SECTION REGARDING IMPORTATION OF 
                   PRESCRIPTION DRUGS.

       Chapter VIII of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 381 et seq.) is amended by striking section 804.

     SEC. _04. IMPORTATION OF PRESCRIPTION DRUGS; WAIVER OF 
                   CERTAIN IMPORT RESTRICTIONS.

       (a) In General.--Chapter VIII of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 381 et seq.), as amended by 
     section _03, is further amended by inserting after section 
     803 the following:

     ``SEC. 804. COMMERCIAL AND PERSONAL IMPORTATION OF 
                   PRESCRIPTION DRUGS.

       ``(a) Importation of Prescription Drugs.--
       ``(1) In general.--In the case of qualifying drugs imported 
     or offered for import into the United States from registered 
     exporters or by registered importers--
       ``(A) the limitation on importation that is established in 
     section 801(d)(1) is waived; and
       ``(B) the standards referred to in section 801(a) regarding 
     admission of the drugs are subject to subsection (g) of this 
     section (including with respect to qualifying drugs to which 
     section 801(d)(1) does not apply).
       ``(2) Importers.--A qualifying drug may not be imported 
     under paragraph (1) unless--
       ``(A) the drug is imported by a pharmacy, group of 
     pharmacies, or a wholesaler that is a registered importer; or
       ``(B) the drug is imported by an individual for personal 
     use or for the use of a family member of the individual (not 
     for resale) from a registered exporter.
       ``(3) Rule of construction.--This section shall apply only 
     with respect to a drug that is imported or offered for import 
     into the United States--
       ``(A) by a registered importer; or
       ``(B) from a registered exporter to an individual.
       ``(4) Definitions.--
       ``(A) Registered exporter; registered importer.--For 
     purposes of this section:
       ``(i) The term `registered exporter' means an exporter for 
     which a registration under subsection (b) has been approved 
     and is in effect.
       ``(ii) The term `registered importer' means a pharmacy, 
     group of pharmacies, or a wholesaler for which a registration 
     under subsection (b) has been approved and is in effect.
       ``(iii) The term `registration condition' means a condition 
     that must exist for a registration under subsection (b) to be 
     approved.
       ``(B) Qualifying drug.--For purposes of this section, the 
     term `qualifying drug' means a drug for which there is a 
     corresponding U.S. label drug.
       ``(C) U.S. label drug.--For purposes of this section, the 
     term `U.S. label drug' means a prescription drug that--
       ``(i) with respect to a qualifying drug, has the same 
     active ingredient or ingredients, route of administration, 
     dosage form, and strength as the qualifying drug;
       ``(ii) with respect to the qualifying drug, is manufactured 
     by or for the person that manufactures the qualifying drug;
       ``(iii) is approved under section 505(c); and
       ``(iv) is not--

       ``(I) a controlled substance, as defined in section 102 of 
     the Controlled Substances Act (21 U.S.C. 802);
       ``(II) a biological product, as defined in section 351 of 
     the Public Health Service Act (42 U.S.C. 262), including--

       ``(aa) a therapeutic DNA plasmid product;
       ``(bb) a therapeutic synthetic peptide product;
       ``(cc) a monoclonal antibody product for in vivo use; and
       ``(dd) a therapeutic recombinant DNA-derived product;

       ``(III) an infused drug, including a peritoneal dialysis 
     solution;
       ``(IV) an injected drug;
       ``(V) a drug that is inhaled during surgery;
       ``(VI) a drug that is the listed drug referred to in 2 or 
     more abbreviated new drug applications under which the drug 
     is commercially marketed; or
       ``(VII) a sterile opthlamic drug intended for topical use 
     on or in the eye.

       ``(D) Other definitions.--For purposes of this section:
       ``(i)(I) The term `exporter' means a person that is in the 
     business of exporting a drug to individuals in the United 
     States from Canada or from a permitted country designated by 
     the Secretary under subclause (II), or that, pursuant to 
     submitting a registration under subsection (b), seeks to be 
     in such business.
       ``(II) The Secretary shall designate a permitted country 
     under subparagraph (E) (other than Canada) as a country from 
     which an exporter may export a drug to individuals in the 
     United States if the Secretary determines that--

       ``(aa) the country has statutory or regulatory standards 
     that are equivalent to the standards in the United States and 
     Canada with respect to--

       ``(AA) the training of pharmacists;
       ``(BB) the practice of pharmacy; and
       ``(CC) the protection of the privacy of personal medical 
     information; and

       ``(bb) the importation of drugs to individuals in the 
     United States from the country will not adversely affect 
     public health.

       ``(ii) The term `importer' means a pharmacy, a group of 
     pharmacies, or a wholesaler that is in the business of 
     importing a drug into the United States or that, pursuant to 
     submitting a registration under subsection (b), seeks to be 
     in such business.
       ``(iii) The term `pharmacist' means a person licensed by a 
     State to practice pharmacy, including the dispensing and 
     selling of prescription drugs.
       ``(iv) The term `pharmacy' means a person that--

       ``(I) is licensed by a State to engage in the business of 
     selling prescription drugs at retail; and
       ``(II) employs 1 or more pharmacists.

       ``(v) The term `prescription drug' means a drug that is 
     described in section 503(b)(1).
       ``(vi) The term `wholesaler'--

       ``(I) means a person licensed as a wholesaler or 
     distributor of prescription drugs in the United States under 
     section 503(e)(2)(A); and
       ``(II) does not include a person authorized to import drugs 
     under section 801(d)(1).

       ``(E) Permitted country.--The term `permitted country' 
     means--
       ``(i) Australia;
       ``(ii) Canada;
       ``(iii) a member country of the European Union, but does 
     not include a member country with respect to which--

       ``(I) the country's Annex to the Treaty of Accession to the 
     European Union 2003 includes a transitional measure for the 
     regulation of human pharmaceutical products that has not 
     expired; or
       ``(II) the Secretary determines that the requirements 
     described in subclauses (I) and (II) of clause (vii) will not 
     be met by the date on which such transitional measure for the 
     regulation of human pharmaceutical products expires;

       ``(iv) Japan;
       ``(v) New Zealand;
       ``(vi) Switzerland; and
       ``(vii) a country in which the Secretary determines the 
     following requirements are met:

       ``(I) The country has statutory or regulatory 
     requirements--

       ``(aa) that require the review of drugs for safety and 
     effectiveness by an entity of the government of the country;
       ``(bb) that authorize the approval of only those drugs that 
     have been determined to be safe and effective by experts 
     employed by or acting on behalf of such entity and qualified 
     by scientific training and experience to evaluate the safety 
     and effectiveness of drugs on the basis of adequate and well-
     controlled investigations, including clinical investigations, 
     conducted by experts qualified by scientific training and 
     experience to evaluate the safety and effectiveness of drugs;
       ``(cc) that require the methods used in, and the facilities 
     and controls used for the manufacture, processing, and 
     packing of drugs in the country to be adequate to preserve 
     their identity, quality, purity, and strength;
       ``(dd) for the reporting of adverse reactions to drugs and 
     procedures to withdraw approval and remove drugs found not to 
     be safe or effective; and
       ``(ee) that require the labeling and promotion of drugs to 
     be in accordance with the approval of the drug.

       ``(II) The valid marketing authorization system in the 
     country is equivalent to the systems in the countries 
     described in clauses (i) through (vi).
       ``(III) The importation of drugs to the United States from 
     the country will not adversely affect public health.

[[Page 10775]]

       ``(b) Registration of Importers and Exporters.--
       ``(1) Registration of importers and exporters.--A 
     registration condition is that the importer or exporter 
     involved (referred to in this subsection as a `registrant') 
     submits to the Secretary a registration containing the 
     following:
       ``(A)(i) In the case of an exporter, the name of the 
     exporter and an identification of all places of business of 
     the exporter that relate to qualifying drugs, including each 
     warehouse or other facility owned or controlled by, or 
     operated for, the exporter.
       ``(ii) In the case of an importer, the name of the importer 
     and an identification of the places of business of the 
     importer at which the importer initially receives a 
     qualifying drug after importation (which shall not exceed 3 
     places of business except by permission of the Secretary).
       ``(B) Such information as the Secretary determines to be 
     necessary to demonstrate that the registrant is in compliance 
     with registration conditions under--
       ``(i) in the case of an importer, subsections (c), (d), 
     (e), (g), and (j) (relating to the sources of imported 
     qualifying drugs; the inspection of facilities of the 
     importer; the payment of fees; compliance with the standards 
     referred to in section 801(a); and maintenance of records and 
     samples); or
       ``(ii) in the case of an exporter, subsections (c), (d), 
     (f), (g), (h), (i), and (j) (relating to the sources of 
     exported qualifying drugs; the inspection of facilities of 
     the exporter and the marking of compliant shipments; the 
     payment of fees; and compliance with the standards referred 
     to in section 801(a); being licensed as a pharmacist; 
     conditions for individual importation; and maintenance of 
     records and samples).
       ``(C) An agreement by the registrant that the registrant 
     will not under subsection (a) import or export any drug that 
     is not a qualifying drug.
       ``(D) An agreement by the registrant to--
       ``(i) notify the Secretary of a recall or withdrawal of a 
     qualifying drug distributed in a permitted country that the 
     registrant has exported or imported, or intends to export or 
     import, to the United States under subsection (a);
       ``(ii) provide for the return to the registrant of such 
     drug; and
       ``(iii) cease, or not begin, the exportation or importation 
     of such drug unless the Secretary has notified the registrant 
     that exportation or importation of such drug may proceed.
       ``(E) An agreement by the registrant to ensure and monitor 
     compliance with each registration condition, to promptly 
     correct any noncompliance with such a condition, and to 
     promptly report to the Secretary any such noncompliance.
       ``(F) A plan describing the manner in which the registrant 
     will comply with the agreement under subparagraph (E).
       ``(G) An agreement by the registrant to enforce a contract 
     under subsection (c)(3)(B) against a party in the chain of 
     custody of a qualifying drug with respect to the authority of 
     the Secretary under clauses (ii) and (iii) of that 
     subsection.
       ``(H) An agreement by the registrant to notify the 
     Secretary not more than 30 days before the registrant intends 
     to make the change, of--
       ``(i) any change that the registrant intends to make 
     regarding information provided under subparagraph (A) or (B); 
     and
       ``(ii) any change that the registrant intends to make in 
     the compliance plan under subparagraph (F).
       ``(I) In the case of an exporter--
       ``(i) An agreement by the exporter that a qualifying drug 
     will not under subsection (a) be exported to any individual 
     not authorized pursuant to subsection (a)(2)(B) to be an 
     importer of such drug.
       ``(ii) An agreement to post a bond, payable to the Treasury 
     of the United States that is equal in value to the lesser 
     of--

       ``(I) the value of drugs exported by the exporter to the 
     United States in a typical 4-week period over the course of a 
     year under this section; or
       ``(II) $1,000,000;

       ``(iii) An agreement by the exporter to comply with 
     applicable provisions of Canadian law, or the law of the 
     permitted country designated under subsection 
     (a)(4)(D)(i)(II) in which the exporter is located, that 
     protect the privacy of personal information with respect to 
     each individual importing a prescription drug from the 
     exporter under subsection (a)(2)(B).
       ``(iv) An agreement by the exporter to report to the 
     Secretary--

       ``(I) not later than August 1 of each fiscal year, the 
     total price and the total volume of drugs exported to the 
     United States by the exporter during the 6-month period from 
     January 1 through June 30 of that year; and
       ``(II) not later than January 1 of each fiscal year, the 
     total price and the total volume of drugs exported to the 
     United States by the exporter during the previous fiscal 
     year.

       ``(J) In the case of an importer, an agreement by the 
     importer to report to the Secretary--
       ``(i) not later than August 1 of each fiscal year, the 
     total price and the total volume of drugs imported to the 
     United States by the importer during the 6-month period from 
     January 1 through June 30 of that fiscal year; and
       ``(ii) not later than January 1 of each fiscal year, the 
     total price and the total volume of drugs imported to the 
     United States by the importer during the previous fiscal 
     year.
       ``(K) Such other provisions as the Secretary may require by 
     regulation to protect the public health while permitting--
       ``(i) the importation by pharmacies, groups of pharmacies, 
     and wholesalers as registered importers of qualifying drugs 
     under subsection (a); and
       ``(ii) importation by individuals of qualifying drugs under 
     subsection (a).
       ``(2) Approval or disapproval of registration.--
       ``(A) In general.--Not later than 90 days after the date on 
     which a registrant submits to the Secretary a registration 
     under paragraph (1), the Secretary shall notify the 
     registrant whether the registration is approved or is 
     disapproved. The Secretary shall disapprove a registration if 
     there is reason to believe that the registrant is not in 
     compliance with one or more registration conditions, and 
     shall notify the registrant of such reason. In the case of a 
     disapproved registration, the Secretary shall subsequently 
     notify the registrant that the registration is approved if 
     the Secretary determines that the registrant is in compliance 
     with such conditions.
       ``(B) Changes in registration information.--Not later than 
     30 days after receiving a notice under paragraph (1)(H) from 
     a registrant, the Secretary shall determine whether the 
     change involved affects the approval of the registration of 
     the registrant under paragraph (1), and shall inform the 
     registrant of the determination.
       ``(3) Publication of contact information for registered 
     exporters.--Through the Internet website of the Food and Drug 
     Administration and a toll-free telephone number, the 
     Secretary shall make readily available to the public a list 
     of registered exporters, including contact information for 
     the exporters. Promptly after the approval of a registration 
     submitted under paragraph (1), the Secretary shall update the 
     Internet website and the information provided through the 
     toll-free telephone number accordingly.
       ``(4) Suspension and termination.--
       ``(A) Suspension.--With respect to the effectiveness of a 
     registration submitted under paragraph (1):
       ``(i) Subject to clause (ii), the Secretary may suspend the 
     registration if the Secretary determines, after notice and 
     opportunity for a hearing, that the registrant has failed to 
     maintain substantial compliance with a registration 
     condition.
       ``(ii) If the Secretary determines that, under color of the 
     registration, the exporter has exported a drug or the 
     importer has imported a drug that is not a qualifying drug, 
     or a drug that does not comply with subsection (g)(2)(A) or 
     (g)(4), or has exported a qualifying drug to an individual in 
     violation of subsection (i)(2)(F), the Secretary shall 
     immediately suspend the registration. A suspension under the 
     preceding sentence is not subject to the provision by the 
     Secretary of prior notice, and the Secretary shall provide to 
     the registrant an opportunity for a hearing not later than 10 
     days after the date on which the registration is suspended.
       ``(iii) The Secretary may reinstate the registration, 
     whether suspended under clause (i) or (ii), if the Secretary 
     determines that the registrant has demonstrated that further 
     violations of registration conditions will not occur.
       ``(B) Termination.--The Secretary, after notice and 
     opportunity for a hearing, may terminate the registration 
     under paragraph (1) of a registrant if the Secretary 
     determines that the registrant has engaged in a pattern or 
     practice of violating 1 or more registration conditions, or 
     if on 1 or more occasions the Secretary has under 
     subparagraph (A)(ii) suspended the registration of the 
     registrant. The Secretary may make the termination permanent, 
     or for a fixed period of not less than 1 year. During the 
     period in which the registration is terminated, any 
     registration submitted under paragraph (1) by the registrant, 
     or a person that is a partner in the export or import 
     enterprise, or a principal officer in such enterprise, and 
     any registration prepared with the assistance of the 
     registrant or such a person, has no legal effect under this 
     section.
       ``(5) Default of bond.--A bond required to be posted by an 
     exporter under paragraph (1)(I)(ii) shall be defaulted and 
     paid to the Treasury of the United States if, after 
     opportunity for an informal hearing, the Secretary determines 
     that the exporter has--
       ``(A) exported a drug to the United States that is not a 
     qualifying drug or that is not in compliance with subsection 
     (g)(2)(A), (g)(4), or (i); or
       ``(B) failed to permit the Secretary to conduct an 
     inspection described under subsection (d).
       ``(c) Sources of Qualifying Drugs.--A registration 
     condition is that the exporter or importer involved agrees 
     that a qualifying drug will under subsection (a) be exported 
     or imported into the United States only if there is 
     compliance with the following:
       ``(1) The drug was manufactured in an establishment--
       ``(A) required to register under subsection (h) or (i) of 
     section 510; and

[[Page 10776]]

       ``(B)(i) inspected by the Secretary; or
       ``(ii) for which the Secretary has elected to rely on a 
     satisfactory report of a good manufacturing practice 
     inspection of the establishment from a permitted country 
     whose regulatory system the Secretary recognizes as 
     equivalent under a mutual recognition agreement, as provided 
     for under section 510(i)(3), section 803, or part 26 of title 
     21, Code of Federal Regulations (or any corresponding 
     successor rule or regulation).
       ``(2) The establishment is located in any country, and the 
     establishment manufactured the drug for distribution in the 
     United States or for distribution in 1 or more of the 
     permitted countries (without regard to whether in addition 
     the drug is manufactured for distribution in a foreign 
     country that is not a permitted country).
       ``(3) The exporter or importer obtained the drug--
       ``(A) directly from the establishment; or
       ``(B) directly from an entity that, by contract with the 
     exporter or importer--
       ``(i) provides to the exporter or importer a statement (in 
     such form and containing such information as the Secretary 
     may require) that, for the chain of custody from the 
     establishment, identifies each prior sale, purchase, or trade 
     of the drug (including the date of the transaction and the 
     names and addresses of all parties to the transaction);
       ``(ii) agrees to permit the Secretary to inspect such 
     statements and related records to determine their accuracy;
       ``(iii) agrees, with respect to the qualifying drugs 
     involved, to permit the Secretary to inspect warehouses and 
     other facilities, including records, of the entity for 
     purposes of determining whether the facilities are in 
     compliance with any standards under this Act that are 
     applicable to facilities of that type in the United States; 
     and
       ``(iv) has ensured, through such contractual relationships 
     as may be necessary, that the Secretary has the same 
     authority regarding other parties in the chain of custody 
     from the establishment that the Secretary has under clauses 
     (ii) and (iii) regarding such entity.
       ``(4)(A) The foreign country from which the importer will 
     import the drug is a permitted country; or
       ``(B) The foreign country from which the exporter will 
     export the drug is the permitted country in which the 
     exporter is located.
       ``(5) During any period in which the drug was not in the 
     control of the manufacturer of the drug, the drug did not 
     enter any country that is not a permitted country.
       ``(6) The exporter or importer retains a sample of each lot 
     of the drug for testing by the Secretary.
       ``(d) Inspection of Facilities; Marking of Shipments.--
       ``(1) Inspection of facilities.--A registration condition 
     is that, for the purpose of assisting the Secretary in 
     determining whether the exporter involved is in compliance 
     with all other registration conditions--
       ``(A) the exporter agrees to permit the Secretary--
       ``(i) to conduct onsite inspections, including monitoring 
     on a day-to-day basis, of places of business of the exporter 
     that relate to qualifying drugs, including each warehouse or 
     other facility owned or controlled by, or operated for, the 
     exporter;
       ``(ii) to have access, including on a day-to-day basis, 
     to--

       ``(I) records of the exporter that relate to the export of 
     such drugs, including financial records; and
       ``(II) samples of such drugs;

       ``(iii) to carry out the duties described in paragraph (3); 
     and
       ``(iv) to carry out any other functions determined by the 
     Secretary to be necessary regarding the compliance of the 
     exporter; and
       ``(B) the Secretary has assigned 1 or more employees of the 
     Secretary to carry out the functions described in this 
     subsection for the Secretary randomly, but not less than 12 
     times annually, on the premises of places of businesses 
     referred to in subparagraph (A)(i), and such an assignment 
     remains in effect on a continuous basis.
       ``(2) Marking of compliant shipments.--A registration 
     condition is that the exporter involved agrees to affix to 
     each shipping container of qualifying drugs exported under 
     subsection (a) such markings as the Secretary determines to 
     be necessary to identify the shipment as being in compliance 
     with all registration conditions. Markings under the 
     preceding sentence shall--
       ``(A) be designed to prevent affixation of the markings to 
     any shipping container that is not authorized to bear the 
     markings; and
       ``(B) include anticounterfeiting or track-and-trace 
     technologies, taking into account the economic and technical 
     feasibility of those technologies.
       ``(3) Certain duties relating to exporters.--Duties of the 
     Secretary with respect to an exporter include the following:
       ``(A) Inspecting, randomly, but not less than 12 times 
     annually, the places of business of the exporter at which 
     qualifying drugs are stored and from which qualifying drugs 
     are shipped.
       ``(B) During the inspections under subparagraph (A), 
     verifying the chain of custody of a statistically significant 
     sample of qualifying drugs from the establishment in which 
     the drug was manufactured to the exporter, which shall be 
     accomplished or supplemented by the use of anticounterfeiting 
     or track-and-trace technologies, taking into account the 
     economic and technical feasibility of those technologies, 
     except that a drug that lacks such technologies from the 
     point of manufacture shall not for that reason be excluded 
     from importation by an exporter.
       ``(C) Randomly reviewing records of exports to individuals 
     for the purpose of determining whether the drugs are being 
     imported by the individuals in accordance with the conditions 
     under subsection (i). Such reviews shall be conducted in a 
     manner that will result in a statistically significant 
     determination of compliance with all such conditions.
       ``(D) Monitoring the affixing of markings under paragraph 
     (2).
       ``(E) Inspecting as the Secretary determines is necessary 
     the warehouses and other facilities, including records, of 
     other parties in the chain of custody of qualifying drugs.
       ``(F) Determining whether the exporter is in compliance 
     with all other registration conditions.
       ``(4) Prior notice of shipments.--A registration condition 
     is that, not less than 8 hours and not more than 5 days in 
     advance of the time of the importation of a shipment of 
     qualifying drugs, the importer involved agrees to submit to 
     the Secretary a notice with respect to the shipment of drugs 
     to be imported or offered for import into the United States 
     under subsection (a). A notice under the preceding sentence 
     shall include--
       ``(A) the name and complete contact information of the 
     person submitting the notice;
       ``(B) the name and complete contact information of the 
     importer involved;
       ``(C) the identity of the drug, including the established 
     name of the drug, the quantity of the drug, and the lot 
     number assigned by the manufacturer;
       ``(D) the identity of the manufacturer of the drug, 
     including the identity of the establishment at which the drug 
     was manufactured;
       ``(E) the country from which the drug is shipped;
       ``(F) the name and complete contact information for the 
     shipper of the drug;
       ``(G) anticipated arrival information, including the port 
     of arrival and crossing location within that port, and the 
     date and time;
       ``(H) a summary of the chain of custody of the drug from 
     the establishment in which the drug was manufactured to the 
     importer;
       ``(I) a declaration as to whether the Secretary has ordered 
     that importation of the drug from the permitted country cease 
     under subsection (g)(2)(C) or (D); and
       ``(J) such other information as the Secretary may require 
     by regulation.
       ``(5) Marking of compliant shipments.--A registration 
     condition is that the importer involved agrees, before 
     wholesale distribution (as defined in section 503(e)) of a 
     qualifying drug that has been imported under subsection (a), 
     to affix to each container of such drug such markings or 
     other technology as the Secretary determines necessary to 
     identify the shipment as being in compliance with all 
     registration conditions, except that the markings or other 
     technology shall not be required on a drug that bears 
     comparable, compatible markings or technology from the 
     manufacturer of the drug. Markings or other technology under 
     the preceding sentence shall--
       ``(A) be designed to prevent affixation of the markings or 
     other technology to any container that is not authorized to 
     bear the markings; and
       ``(B) shall include anticounterfeiting or track-and-trace 
     technologies, taking into account the economic and technical 
     feasibility of such technologies.
       ``(6) Certain duties relating to importers.--Duties of the 
     Secretary with respect to an importer include the following:
       ``(A) Inspecting, randomly, but not less than 12 times 
     annually, the places of business of the importer at which a 
     qualifying drug is initially received after importation.
       ``(B) During the inspections under subparagraph (A), 
     verifying the chain of custody of a statistically significant 
     sample of qualifying drugs from the establishment in which 
     the drug was manufactured to the importer, which shall be 
     accomplished or supplemented by the use of anticounterfeiting 
     or track-and-trace technologies, taking into account the 
     economic and technical feasibility of those technologies, 
     except that a drug that lacks such technologies from the 
     point of manufacture shall not for that reason be excluded 
     from importation by an importer.
       ``(C) Reviewing notices under paragraph (4).
       ``(D) Inspecting as the Secretary determines is necessary 
     the warehouses and other facilities, including records of 
     other parties in the chain of custody of qualifying drugs.
       ``(E) Determining whether the importer is in compliance 
     with all other registration conditions.
       ``(e) Importer Fees.--
       ``(1) Registration fee.--A registration condition is that 
     the importer involved pays to the Secretary a fee of $10,000 
     due on the date on which the importer first submits the 
     registration to the Secretary under subsection (b).
       ``(2) Inspection fee.--A registration condition is that the 
     importer involved pays a fee

[[Page 10777]]

     to the Secretary in accordance with this subsection. Such fee 
     shall be paid not later than October 1 and April 1 of each 
     fiscal year in the amount provided for under paragraph (3).
       ``(3) Amount of inspection fee.--
       ``(A) Aggregate total of fees.--Not later than 30 days 
     before the start of each fiscal year, the Secretary, in 
     consultation with the Secretary of Homeland Security and the 
     Secretary of the Treasury, shall establish an aggregate total 
     of fees to be collected under paragraph (2) for importers for 
     that fiscal year that is sufficient, and not more than 
     necessary, to pay the costs for that fiscal year of 
     administering this section with respect to registered 
     importers, including the costs associated with--
       ``(i) inspecting the facilities of registered importers, 
     and of other entities in the chain of custody of a qualifying 
     drug as necessary, under subsection (d)(6);
       ``(ii) developing, implementing, and operating under such 
     subsection an electronic system for submission and review of 
     the notices required under subsection (d)(4) with respect to 
     shipments of qualifying drugs under subsection (a) to assess 
     compliance with all registration conditions when such 
     shipments are offered for import into the United States; and
       ``(iii) inspecting such shipments as necessary, when 
     offered for import into the United States to determine if 
     such a shipment should be refused admission under subsection 
     (g)(5).
       ``(B) Limitation.--Subject to subparagraph (C), the 
     aggregate total of fees collected under paragraph (2) for a 
     fiscal year shall not exceed 2.5 percent of the total price 
     of qualifying drugs imported during that fiscal year into the 
     United States by registered importers under subsection (a).
       ``(C) Total price of drugs.--
       ``(i) Estimate.--For the purposes of complying with the 
     limitation described in subparagraph (B) when establishing 
     under subparagraph (A) the aggregate total of fees to be 
     collected under paragraph (2) for a fiscal year, the 
     Secretary shall estimate the total price of qualifying drugs 
     imported into the United States by registered importers 
     during that fiscal year by adding the total price of 
     qualifying drugs imported by each registered importer during 
     the 6-month period from January 1 through June 30 of the 
     previous fiscal year, as reported to the Secretary by each 
     registered importer under subsection (b)(1)(J).
       ``(ii) Calculation.--Not later than March 1 of the fiscal 
     year that follows the fiscal year for which the estimate 
     under clause (i) is made, the Secretary shall calculate the 
     total price of qualifying drugs imported into the United 
     States by registered importers during that fiscal year by 
     adding the total price of qualifying drugs imported by each 
     registered importer during that fiscal year, as reported to 
     the Secretary by each registered importer under subsection 
     (b)(1)(J).
       ``(iii) Adjustment.--If the total price of qualifying drugs 
     imported into the United States by registered importers 
     during a fiscal year as calculated under clause (ii) is less 
     than the aggregate total of fees collected under paragraph 
     (2) for that fiscal year, the Secretary shall provide for a 
     pro-rata reduction in the fee due from each registered 
     importer on April 1 of the subsequent fiscal year so that the 
     limitation described in subparagraph (B) is observed.
       ``(D) Individual importer fee.--Subject to the limitation 
     described in subparagraph (B), the fee under paragraph (2) to 
     be paid on October 1 and April 1 by an importer shall be an 
     amount that is proportional to a reasonable estimate by the 
     Secretary of the semiannual share of the importer of the 
     volume of qualifying drugs imported by importers under 
     subsection (a).
       ``(4) Use of fees.--
       ``(A) In general.--Subject to appropriations Acts, fees 
     collected by the Secretary under paragraphs (1) and (2) shall 
     be credited to the appropriation account for salaries and 
     expenses of the Food and Drug Administration until expended 
     (without fiscal year limitation), and the Secretary may, in 
     consultation with the Secretary of Homeland Security and the 
     Secretary of the Treasury, transfer some proportion of such 
     fees to the appropriation account for salaries and expenses 
     of the Bureau of Customs and Border Protection until expended 
     (without fiscal year limitation).
       ``(B) Sole purpose.--Fees collected by the Secretary under 
     paragraphs (1) and (2) are only available to the Secretary 
     and, if transferred, to the Secretary of Homeland Security, 
     and are for the sole purpose of paying the costs referred to 
     in paragraph (3)(A).
       ``(5) Collection of fees.--In any case where the Secretary 
     does not receive payment of a fee assessed under paragraph 
     (1) or (2) within 30 days after it is due, such fee shall be 
     treated as a claim of the United States Government subject to 
     subchapter II of chapter 37 of title 31, United States Code.
       ``(f) Exporter Fees.--
       ``(1) Registration fee.--A registration condition is that 
     the exporter involved pays to the Secretary a fee of $10,000 
     due on the date on which the exporter first submits that 
     registration to the Secretary under subsection (b).
       ``(2) Inspection fee.--A registration condition is that the 
     exporter involved pays a fee to the Secretary in accordance 
     with this subsection. Such fee shall be paid not later than 
     October 1 and April 1 of each fiscal year in the amount 
     provided for under paragraph (3).
       ``(3) Amount of inspection fee.--
       ``(A) Aggregate total of fees.--Not later than 30 days 
     before the start of each fiscal year, the Secretary, in 
     consultation with the Secretary of Homeland Security and the 
     Secretary of the Treasury, shall establish an aggregate total 
     of fees to be collected under paragraph (2) for exporters for 
     that fiscal year that is sufficient, and not more than 
     necessary, to pay the costs for that fiscal year of 
     administering this section with respect to registered 
     exporters, including the costs associated with--
       ``(i) inspecting the facilities of registered exporters, 
     and of other entities in the chain of custody of a qualifying 
     drug as necessary, under subsection (d)(3);
       ``(ii) developing, implementing, and operating under such 
     subsection a system to screen marks on shipments of 
     qualifying drugs under subsection (a) that indicate 
     compliance with all registration conditions, when such 
     shipments are offered for import into the United States; and
       ``(iii) screening such markings, and inspecting such 
     shipments as necessary, when offered for import into the 
     United States to determine if such a shipment should be 
     refused admission under subsection (g)(5).
       ``(B) Limitation.--Subject to subparagraph (C), the 
     aggregate total of fees collected under paragraph (2) for a 
     fiscal year shall not exceed 2.5 percent of the total price 
     of qualifying drugs imported during that fiscal year into the 
     United States by registered exporters under subsection (a).
       ``(C) Total price of drugs.--
       ``(i) Estimate.--For the purposes of complying with the 
     limitation described in subparagraph (B) when establishing 
     under subparagraph (A) the aggregate total of fees to be 
     collected under paragraph (2) for a fiscal year, the 
     Secretary shall estimate the total price of qualifying drugs 
     imported into the United States by registered exporters 
     during that fiscal year by adding the total price of 
     qualifying drugs exported by each registered exporter during 
     the 6-month period from January 1 through June 30 of the 
     previous fiscal year, as reported to the Secretary by each 
     registered exporter under subsection (b)(1)(I)(iv).
       ``(ii) Calculation.--Not later than March 1 of the fiscal 
     year that follows the fiscal year for which the estimate 
     under clause (i) is made, the Secretary shall calculate the 
     total price of qualifying drugs imported into the United 
     States by registered exporters during that fiscal year by 
     adding the total price of qualifying drugs exported by each 
     registered exporter during that fiscal year, as reported to 
     the Secretary by each registered exporter under subsection 
     (b)(1)(I)(iv).
       ``(iii) Adjustment.--If the total price of qualifying drugs 
     imported into the United States by registered exporters 
     during a fiscal year as calculated under clause (ii) is less 
     than the aggregate total of fees collected under paragraph 
     (2) for that fiscal year, the Secretary shall provide for a 
     pro-rata reduction in the fee due from each registered 
     exporter on April 1 of the subsequent fiscal year so that the 
     limitation described in subparagraph (B) is observed.
       ``(D) Individual exporter fee.--Subject to the limitation 
     described in subparagraph (B), the fee under paragraph (2) to 
     be paid on October 1 and April 1 by an exporter shall be an 
     amount that is proportional to a reasonable estimate by the 
     Secretary of the semiannual share of the exporter of the 
     volume of qualifying drugs exported by exporters under 
     subsection (a).
       ``(4) Use of fees.--
       ``(A) In general.--Subject to appropriations Acts, fees 
     collected by the Secretary under paragraphs (1) and (2) shall 
     be credited to the appropriation account for salaries and 
     expenses of the Food and Drug Administration until expended 
     (without fiscal year limitation), and the Secretary may, in 
     consultation with the Secretary of Homeland Security and the 
     Secretary of the Treasury, transfer some proportion of such 
     fees to the appropriation account for salaries and expenses 
     of the Bureau of Customs and Border Protection until expended 
     (without fiscal year limitation).
       ``(B) Sole purpose.--Fees collected by the Secretary under 
     paragraphs (1) and (2) are only available to the Secretary 
     and, if transferred, to the Secretary of Homeland Security, 
     and are for the sole purpose of paying the costs referred to 
     in paragraph (3)(A).
       ``(5) Collection of fees.--In any case where the Secretary 
     does not receive payment of a fee assessed under paragraph 
     (1) or (2) within 30 days after it is due, such fee shall be 
     treated as a claim of the United States Government subject to 
     subchapter II of chapter 37 of title 31, United States Code.
       ``(g) Compliance With Section 801(a).--
       ``(1) In general.--A registration condition is that each 
     qualifying drug exported under subsection (a) by the 
     registered exporter involved or imported under subsection (a) 
     by the registered importer involved is in compliance with the 
     standards referred to in section 801(a) regarding admission 
     of the drug into the United States, subject to paragraphs 
     (2), (3), and (4).
       ``(2) Section 505; approval status.--

[[Page 10778]]

       ``(A) In general.--A qualifying drug that is imported or 
     offered for import under subsection (a) shall comply with the 
     conditions established in the approved application under 
     section 505(b) for the U.S. label drug as described under 
     this subsection.
       ``(B) Notice by manufacturer; general provisions.--
       ``(i) In general.--The person that manufactures a 
     qualifying drug that is, or will be, introduced for 
     commercial distribution in a permitted country shall in 
     accordance with this paragraph submit to the Secretary a 
     notice that--

       ``(I) includes each difference in the qualifying drug from 
     a condition established in the approved application for the 
     U.S. label drug beyond--

       ``(aa) the variations provided for in the application; and
       ``(bb) any difference in labeling (except ingredient 
     labeling); or

       ``(II) states that there is no difference in the qualifying 
     drug from a condition established in the approved application 
     for the U.S. label drug beyond--

       ``(aa) the variations provided for in the application; and
       ``(bb) any difference in labeling (except ingredient 
     labeling).
       ``(ii) Information in notice.--A notice under clause (i)(I) 
     shall include the information that the Secretary may require 
     under section 506A, any additional information the Secretary 
     may require (which may include data on bioequivalence if such 
     data are not required under section 506A), and, with respect 
     to the permitted country that approved the qualifying drug 
     for commercial distribution, or with respect to which such 
     approval is sought, include the following:

       ``(I) The date on which the qualifying drug with such 
     difference was, or will be, introduced for commercial 
     distribution in the permitted country.
       ``(II) Information demonstrating that the person submitting 
     the notice has also notified the government of the permitted 
     country in writing that the person is submitting to the 
     Secretary a notice under clause (i)(I), which notice 
     describes the difference in the qualifying drug from a 
     condition established in the approved application for the 
     U.S. label drug.
       ``(III) The information that the person submitted or will 
     submit to the government of the permitted country for 
     purposes of obtaining approval for commercial distribution of 
     the drug in the country which, if in a language other than 
     English, shall be accompanied by an English translation 
     verified to be complete and accurate, with the name, address, 
     and a brief statement of the qualifications of the person 
     that made the translation.

       ``(iii) Certifications.--The chief executive officer and 
     the chief medical officer of the manufacturer involved shall 
     each certify in the notice under clause (i) that--

       ``(I) the information provided in the notice is complete 
     and true; and
       ``(II) a copy of the notice has been provided to the 
     Federal Trade Commission and to the State attorneys general.

       ``(iv) Fee.--If a notice submitted under clause (i) 
     includes a difference that would, under section 506A, require 
     the submission of a supplemental application if made as a 
     change to the U.S. label drug, the person that submits the 
     notice shall pay to the Secretary a fee in the same amount as 
     would apply if the person were paying a fee pursuant to 
     section 736(a)(1)(A)(ii). Subject to appropriations Acts, 
     fees collected by the Secretary under the preceding sentence 
     are available only to the Secretary and are for the sole 
     purpose of paying the costs of reviewing notices submitted 
     under clause (i).
       ``(v) Timing of submission of notices.--

       ``(I) Prior approval notices.--A notice under clause (i) to 
     which subparagraph (C) applies shall be submitted to the 
     Secretary not later than 120 days before the qualifying drug 
     with the difference is introduced for commercial distribution 
     in a permitted country, unless the country requires that 
     distribution of the qualifying drug with the difference begin 
     less than 120 days after the country requires the difference.
       ``(II) Other approval notices.--A notice under clause (i) 
     to which subparagraph (D) applies shall be submitted to the 
     Secretary not later than the day on which the qualifying drug 
     with the difference is introduced for commercial distribution 
     in a permitted country.
       ``(III) Other notices.--A notice under clause (i) to which 
     subparagraph (E) applies shall be submitted to the Secretary 
     on the date that the qualifying drug is first introduced for 
     commercial distribution in a permitted country and annually 
     thereafter.

       ``(vi) Review by secretary.--

       ``(I) In general.--In this paragraph, the difference in a 
     qualifying drug that is submitted in a notice under clause 
     (i) from the U.S. label drug shall be treated by the 
     Secretary as if it were a manufacturing change to the U.S. 
     label drug under section 506A.
       ``(II) Standard of review.--Except as provided in subclause 
     (III), the Secretary shall review and approve or disapprove 
     the difference in a notice submitted under clause (i), if 
     required under section 506A, using the safe and effective 
     standard for approving or disapproving a manufacturing change 
     under section 506A.
       ``(III) Bioequivalence.--If the Secretary would approve the 
     difference in a notice submitted under clause (i) using the 
     safe and effective standard under section 506A and if the 
     Secretary determines that the qualifying drug is not 
     bioequivalent to the U.S. label drug, the Secretary shall--

       ``(aa) include in the labeling provided under paragraph (3) 
     a prominent advisory that the qualifying drug is safe and 
     effective but is not bioequivalent to the U.S. label drug if 
     the Secretary determines that such an advisory is necessary 
     for health care practitioners and patients to use the 
     qualifying drug safely and effectively; or
       ``(bb) decline to approve the difference if the Secretary 
     determines that the availability of both the qualifying drug 
     and the U.S. label drug would pose a threat to the public 
     health.

       ``(IV) Review by the secretary.--The Secretary shall review 
     and approve or disapprove the difference in a notice 
     submitted under clause (i), if required under section 506A, 
     not later than 120 days after the date on which the notice is 
     submitted.
       ``(V) Establishment inspection.--If review of such 
     difference would require an inspection of the establishment 
     in which the qualifying drug is manufactured--

       ``(aa) such inspection by the Secretary shall be 
     authorized; and
       ``(bb) the Secretary may rely on a satisfactory report of a 
     good manufacturing practice inspection of the establishment 
     from a permitted country whose regulatory system the 
     Secretary recognizes as equivalent under a mutual recognition 
     agreement, as provided under section 510(i)(3), section 803, 
     or part 26 of title 21, Code of Federal Regulations (or any 
     corresponding successor rule or regulation).
       ``(vii) Publication of information on notices.--

       ``(I) In general.--Through the Internet website of the Food 
     and Drug Administration and a toll-free telephone number, the 
     Secretary shall readily make available to the public a list 
     of notices submitted under clause (i).
       ``(II) Contents.--The list under subclause (I) shall 
     include the date on which a notice is submitted and whether--

       ``(aa) a notice is under review;
       ``(bb) the Secretary has ordered that importation of the 
     qualifying drug from a permitted country cease; or
       ``(cc) the importation of the drug is permitted under 
     subsection (a).

       ``(III) Update.--The Secretary shall promptly update the 
     Internet website with any changes to the list.

       ``(C) Notice; drug difference requiring prior approval.--In 
     the case of a notice under subparagraph (B)(i) that includes 
     a difference that would, under section 506A(c) or 
     (d)(3)(B)(i), require the approval of a supplemental 
     application before the difference could be made to the U.S. 
     label drug the following shall occur:
       ``(i) Promptly after the notice is submitted, the Secretary 
     shall notify registered exporters, registered importers, the 
     Federal Trade Commission, and the State attorneys general 
     that the notice has been submitted with respect to the 
     qualifying drug involved.
       ``(ii) If the Secretary has not made a determination 
     whether such a supplemental application regarding the U.S. 
     label drug would be approved or disapproved by the date on 
     which the qualifying drug involved is to be introduced for 
     commercial distribution in a permitted country, the Secretary 
     shall--

       ``(I) order that the importation of the qualifying drug 
     involved from the permitted country not begin until the 
     Secretary completes review of the notice; and
       ``(II) promptly notify registered exporters, registered 
     importers, the Federal Trade Commission, and the State 
     attorneys general of the order.

       ``(iii) If the Secretary determines that such a 
     supplemental application regarding the U.S. label drug would 
     not be approved, the Secretary shall--

       ``(I) order that the importation of the qualifying drug 
     involved from the permitted country cease, or provide that an 
     order under clause (ii), if any, remains in effect;
       ``(II) notify the permitted country that approved the 
     qualifying drug for commercial distribution of the 
     determination; and
       ``(III) promptly notify registered exporters, registered 
     importers, the Federal Trade Commission, and the State 
     attorneys general of the determination.

       ``(iv) If the Secretary determines that such a supplemental 
     application regarding the U.S. label drug would be approved, 
     the Secretary shall--

       ``(I) vacate the order under clause (ii), if any;
       ``(II) consider the difference to be a variation provided 
     for in the approved application for the U.S. label drug;
       ``(III) permit importation of the qualifying drug under 
     subsection (a); and
       ``(IV) promptly notify registered exporters, registered 
     importers, the Federal Trade Commission, and the State 
     attorneys general of the determination.

       ``(D) Notice; drug difference not requiring prior 
     approval.--In the case of a notice under subparagraph (B)(i) 
     that includes a difference that would, under section 
     506A(d)(3)(B)(ii), not require the approval of

[[Page 10779]]

     a supplemental application before the difference could be 
     made to the U.S. label drug the following shall occur:
       ``(i) During the period in which the notice is being 
     reviewed by the Secretary, the authority under this 
     subsection to import the qualifying drug involved continues 
     in effect.
       ``(ii) If the Secretary determines that such a supplemental 
     application regarding the U.S. label drug would not be 
     approved, the Secretary shall--

       ``(I) order that the importation of the qualifying drug 
     involved from the permitted country cease;
       ``(II) notify the permitted country that approved the 
     qualifying drug for commercial distribution of the 
     determination; and
       ``(III) promptly notify registered exporters, registered 
     importers, the Federal Trade Commission, and the State 
     attorneys general of the determination.

       ``(iii) If the Secretary determines that such a 
     supplemental application regarding the U.S. label drug would 
     be approved, the difference shall be considered to be a 
     variation provided for in the approved application for the 
     U.S. label drug.
       ``(E) Notice; drug difference not requiring approval; no 
     difference.--In the case of a notice under subparagraph 
     (B)(i) that includes a difference for which, under section 
     506A(d)(1)(A), a supplemental application would not be 
     required for the difference to be made to the U.S. label 
     drug, or that states that there is no difference, the 
     Secretary--
       ``(i) shall consider such difference to be a variation 
     provided for in the approved application for the U.S. label 
     drug;
       ``(ii) may not order that the importation of the qualifying 
     drug involved cease; and
       ``(iii) shall promptly notify registered exporters and 
     registered importers.
       ``(F) Differences in active ingredient, route of 
     administration, dosage form, or strength.--
       ``(i) In general.--A person who manufactures a drug 
     approved under section 505(b) shall submit an application 
     under section 505(b) for approval of another drug that is 
     manufactured for distribution in a permitted country by or 
     for the person that manufactures the drug approved under 
     section 505(b) if--

       ``(I) there is no qualifying drug in commercial 
     distribution in permitted countries whose combined population 
     represents at least 50 percent of the total population of all 
     permitted countries with the same active ingredient or 
     ingredients, route of administration, dosage form, and 
     strength as the drug approved under section 505(b); and
       ``(II) each active ingredient of the other drug is related 
     to an active ingredient of the drug approved under section 
     505(b), as defined in clause (v).

       ``(ii) Application under section 505(b).--The application 
     under section 505(b) required under clause (i) shall--

       ``(I) request approval of the other drug for the indication 
     or indications for which the drug approved under section 
     505(b) is labeled;
       ``(II) include the information that the person submitted to 
     the government of the permitted country for purposes of 
     obtaining approval for commercial distribution of the other 
     drug in that country, which if in a language other than 
     English, shall be accompanied by an English translation 
     verified to be complete and accurate, with the name, address, 
     and a brief statement of the qualifications of the person 
     that made the translation;
       ``(III) include a right of reference to the application for 
     the drug approved under section 505(b); and
       ``(IV) include such additional information as the Secretary 
     may require.

       ``(iii) Timing of submission of application.--An 
     application under section 505(b) required under clause (i) 
     shall be submitted to the Secretary not later than the day on 
     which the information referred to in clause (ii)(II) is 
     submitted to the government of the permitted country.
       ``(iv) Notice of decision on application.--The Secretary 
     shall promptly notify registered exporters, registered 
     importers, the Federal Trade Commission, and the State 
     attorneys general of a determination to approve or to 
     disapprove an application under section 505(b) required under 
     clause (i).
       ``(v) Related active ingredients.--For purposes of clause 
     (i)(II), 2 active ingredients are related if they are--

       ``(I) the same; or
       ``(II) different salts, esters, or complexes of the same 
     moiety.

       ``(3) Section 502; labeling.--
       ``(A) Importation by registered importer.--
       ``(i) In general.--In the case of a qualifying drug that is 
     imported or offered for import by a registered importer, such 
     drug shall be considered to be in compliance with section 502 
     and the labeling requirements under the approved application 
     for the U.S. label drug if the qualifying drug bears--

       ``(I) a copy of the labeling approved for the U.S. label 
     drug under section 505, without regard to whether the copy 
     bears any trademark involved;
       ``(II) the name of the manufacturer and location of the 
     manufacturer;
       ``(III) the lot number assigned by the manufacturer;
       ``(IV) the name, location, and registration number of the 
     importer; and
       ``(V) the National Drug Code number assigned to the 
     qualifying drug by the Secretary.

       ``(ii) Request for copy of the labeling.--The Secretary 
     shall provide such copy to the registered importer involved, 
     upon request of the importer.
       ``(iii) Requested labeling.--The labeling provided by the 
     Secretary under clause (ii) shall--

       ``(I) include the established name, as defined in section 
     502(e)(3), for each active ingredient in the qualifying drug;
       ``(II) not include the proprietary name of the U.S. label 
     drug or any active ingredient thereof;
       ``(III) if required under paragraph (2)(B)(vi)(III), a 
     prominent advisory that the qualifying drug is safe and 
     effective but not bioequivalent to the U.S. label drug; and
       ``(IV) if the inactive ingredients of the qualifying drug 
     are different from the inactive ingredients for the U.S. 
     label drug, include--

       ``(aa) a prominent notice that the ingredients of the 
     qualifying drug differ from the ingredients of the U.S. label 
     drug and that the qualifying drug must be dispensed with an 
     advisory to people with allergies about this difference and a 
     list of ingredients; and
       ``(bb) a list of the ingredients of the qualifying drug as 
     would be required under section 502(e).
       ``(B) Importation by individual.--
       ``(i) In general.--In the case of a qualifying drug that is 
     imported or offered for import by a registered exporter to an 
     individual, such drug shall be considered to be in compliance 
     with section 502 and the labeling requirements under the 
     approved application for the U.S. label drug if the packaging 
     and labeling of the qualifying drug complies with all 
     applicable regulations promulgated under sections 3 and 4 of 
     the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 
     et seq.) and the labeling of the qualifying drug includes--

       ``(I) directions for use by the consumer;
       ``(II) the lot number assigned by the manufacturer;
       ``(III) the name and registration number of the exporter;
       ``(IV) if required under paragraph (2)(B)(vi)(III), a 
     prominent advisory that the drug is safe and effective but 
     not bioequivalent to the U.S. label drug;
       ``(V) if the inactive ingredients of the drug are different 
     from the inactive ingredients for the U.S. label drug--

       ``(aa) a prominent advisory that persons with an allergy 
     should check the ingredient list of the drug because the 
     ingredients of the drug differ from the ingredients of the 
     U.S. label drug; and
       ``(bb) a list of the ingredients of the drug as would be 
     required under section 502(e); and

       ``(VI) a copy of any special labeling that would be 
     required by the Secretary had the U.S. label drug been 
     dispensed by a pharmacist in the United States, without 
     regard to whether the special labeling bears any trademark 
     involved.

       ``(ii) Packaging.--A qualifying drug offered for import to 
     an individual by an exporter under this section that is 
     packaged in a unit-of-use container (as those items are 
     defined in the United States Pharmacopeia and National 
     Formulary) shall not be repackaged, provided that--

       ``(I) the packaging complies with all applicable 
     regulations under sections 3 and 4 of the Poison Prevention 
     Packaging Act of 1970 (15 U.S.C. 1471 et seq.); or
       ``(II) the consumer consents to waive the requirements of 
     such Act, after being informed that the packaging does not 
     comply with such Act and that the exporter will provide the 
     drug in packaging that is compliant at no additional cost.

       ``(iii) Request for copy of special labeling and ingredient 
     list.--The Secretary shall provide to the registered exporter 
     involved a copy of the special labeling, the advisory, and 
     the ingredient list described under clause (i), upon request 
     of the exporter.
       ``(iv) Requested labeling and ingredient list.--The 
     labeling and ingredient list provided by the Secretary under 
     clause (iii) shall--

       ``(I) include the established name, as defined in section 
     502(e)(3), for each active ingredient in the drug; and
       ``(II) not include the proprietary name of the U.S. label 
     drug or any active ingredient thereof.

       ``(4) Section 501; adulteration.--A qualifying drug that is 
     imported or offered for import under subsection (a) shall be 
     considered to be in compliance with section 501 if the drug 
     is in compliance with subsection (c).
       ``(5) Standards for refusing admission.--A drug exported 
     under subsection (a) from a registered exporter or imported 
     by a registered importer may be refused admission into the 
     United States if 1 or more of the following applies:
       ``(A) The drug is not a qualifying drug.
       ``(B) A notice for the drug required under paragraph (2)(B) 
     has not been submitted to the Secretary.
       ``(C) The Secretary has ordered that importation of the 
     drug from the permitted country cease under paragraph (2) (C) 
     or (D).
       ``(D) The drug does not comply with paragraph (3) or (4).

[[Page 10780]]

       ``(E) The shipping container appears damaged in a way that 
     may affect the strength, quality, or purity of the drug.
       ``(F) The Secretary becomes aware that--
       ``(i) the drug may be counterfeit;
       ``(ii) the drug may have been prepared, packed, or held 
     under insanitary conditions; or
       ``(iii) the methods used in, or the facilities or controls 
     used for, the manufacturing, processing, packing, or holding 
     of the drug do not conform to good manufacturing practice.
       ``(G) The Secretary has obtained an injunction under 
     section 302 that prohibits the distribution of the drug in 
     interstate commerce.
       ``(H) The Secretary has under section 505(e) withdrawn 
     approval of the drug.
       ``(I) The manufacturer of the drug has instituted a recall 
     of the drug.
       ``(J) If the drug is imported or offered for import by a 
     registered importer without submission of a notice in 
     accordance with subsection (d)(4).
       ``(K) If the drug is imported or offered for import from a 
     registered exporter to an individual and 1 or more of the 
     following applies:
       ``(i) The shipping container for such drug does not bear 
     the markings required under subsection (d)(2).
       ``(ii) The markings on the shipping container appear to be 
     counterfeit.
       ``(iii) The shipping container or markings appear to have 
     been tampered with.
       ``(h) Exporter Licensure in Permitted Country.--A 
     registration condition is that the exporter involved agrees 
     that a qualifying drug will be exported to an individual only 
     if the Secretary has verified that--
       ``(1) the exporter is authorized under the law of the 
     permitted country in which the exporter is located to 
     dispense prescription drugs; and
       ``(2) the exporter employs persons that are licensed under 
     the law of the permitted country in which the exporter is 
     located to dispense prescription drugs in sufficient number 
     to dispense safely the drugs exported by the exporter to 
     individuals, and the exporter assigns to those persons 
     responsibility for dispensing such drugs to individuals.
       ``(i) Individuals; Conditions for Importation.--
       ``(1) In general.--For purposes of subsection (a)(2)(B), 
     the importation of a qualifying drug by an individual is in 
     accordance with this subsection if the following conditions 
     are met:
       ``(A) The drug is accompanied by a copy of a prescription 
     for the drug, which prescription--
       ``(i) is valid under applicable Federal and State laws; and
       ``(ii) was issued by a practitioner who, under the law of a 
     State of which the individual is a resident, or in which the 
     individual receives care from the practitioner who issues the 
     prescription, is authorized to administer prescription drugs.
       ``(B) The drug is accompanied by a copy of the 
     documentation that was required under the law or regulations 
     of the permitted country in which the exporter is located, as 
     a condition of dispensing the drug to the individual.
       ``(C) The copies referred to in subparagraphs (A)(i) and 
     (B) are marked in a manner sufficient--
       ``(i) to indicate that the prescription, and the equivalent 
     document in the permitted country in which the exporter is 
     located, have been filled; and
       ``(ii) to prevent a duplicative filling by another 
     pharmacist.
       ``(D) The individual has provided to the registered 
     exporter a complete list of all drugs used by the individual 
     for review by the individuals who dispense the drug.
       ``(E) The quantity of the drug does not exceed a 90-day 
     supply.
       ``(F) The drug is not an ineligible subpart H drug. For 
     purposes of this section, a prescription drug is an 
     `ineligible subpart H drug' if the drug was approved by the 
     Secretary under subpart H of part 314 of title 21, Code of 
     Federal Regulations (relating to accelerated approval), with 
     restrictions under section 520 of such part to assure safe 
     use, and the Secretary has published in the Federal Register 
     a notice that the Secretary has determined that good cause 
     exists to prohibit the drug from being imported pursuant to 
     this subsection.
       ``(2) Notice regarding drug refused admission.--If a 
     registered exporter ships a drug to an individual pursuant to 
     subsection (a)(2)(B) and the drug is refused admission to the 
     United States, a written notice shall be sent to the 
     individual and to the exporter that informs the individual 
     and the exporter of such refusal and the reason for the 
     refusal.
       ``(j) Maintenance of Records and Samples.--
       ``(1) In general.--A registration condition is that the 
     importer or exporter involved shall--
       ``(A) maintain records required under this section for not 
     less than 2 years; and
       ``(B) maintain samples of each lot of a qualifying drug 
     required under this section for not more than 2 years.
       ``(2) Place of record maintenance.--The records described 
     under paragraph (1) shall be maintained--
       ``(A) in the case of an importer, at the place of business 
     of the importer at which the importer initially receives the 
     qualifying drug after importation; or
       ``(B) in the case of an exporter, at the facility from 
     which the exporter ships the qualifying drug to the United 
     States.
       ``(k) Drug Recalls.--
       ``(1) Manufacturers.--A person that manufactures a 
     qualifying drug imported from a permitted country under this 
     section shall promptly inform the Secretary--
       ``(A) if the drug is recalled or withdrawn from the market 
     in a permitted country;
       ``(B) how the drug may be identified, including lot number; 
     and
       ``(C) the reason for the recall or withdrawal.
       ``(2) Secretary.--With respect to each permitted country, 
     the Secretary shall--
       ``(A) enter into an agreement with the government of the 
     country to receive information about recalls and withdrawals 
     of qualifying drugs in the country; or
       ``(B) monitor recalls and withdrawals of qualifying drugs 
     in the country using any information that is available to the 
     public in any media.
       ``(3) Notice.--The Secretary may notify, as appropriate, 
     registered exporters, registered importers, wholesalers, 
     pharmacies, or the public of a recall or withdrawal of a 
     qualifying drug in a permitted country.
       ``(l) Drug Labeling and Packaging.--
       ``(1) In general.--When a qualifying drug that is imported 
     into the United States by an importer under subsection (a) is 
     dispensed by a pharmacist to an individual, the pharmacist 
     shall provide that the packaging and labeling of the drug 
     complies with all applicable regulations promulgated under 
     sections 3 and 4 of the Poison Prevention Packaging Act of 
     1970 (15 U.S.C. 1471 et seq.) and shall include with any 
     other labeling provided to the individual the following:
       ``(A) The lot number assigned by the manufacturer.
       ``(B) The name and registration number of the importer.
       ``(C) If required under paragraph (2)(B)(vi)(III) of 
     subsection (g), a prominent advisory that the drug is safe 
     and effective but not bioequivalent to the U.S. label drug.
       ``(D) If the inactive ingredients of the drug are different 
     from the inactive ingredients for the U.S. label drug--
       ``(i) a prominent advisory that persons with allergies 
     should check the ingredient list of the drug because the 
     ingredients of the drug differ from the ingredients of the 
     U.S. label drug; and
       ``(ii) a list of the ingredients of the drug as would be 
     required under section 502(e).
       ``(2) Packaging.--A qualifying drug that is packaged in a 
     unit-of-use container (as those terms are defined in the 
     United States Pharmacopeia and National Formulary) shall not 
     be repackaged, provided that--
       ``(A) the packaging complies with all applicable 
     regulations under sections 3 and 4 of the Poison Prevention 
     Packaging Act of 1970 (15 U.S.C. 1471 et seq.); or
       ``(B) the consumer consents to waive the requirements of 
     such Act, after being informed that the packaging does not 
     comply with such Act and that the pharmacist will provide the 
     drug in packaging that is compliant at no additional cost.
       ``(m) Charitable Contributions.--Notwithstanding any other 
     provision of this section, this section does not authorize 
     the importation into the United States of a qualifying drug 
     donated or otherwise supplied for free or at nominal cost by 
     the manufacturer of the drug to a charitable or humanitarian 
     organization, including the United Nations and affiliates, or 
     to a government of a foreign country.
       ``(n) Unfair and Discriminatory Acts and Practices.--
       ``(1) In general.--It is unlawful for a manufacturer, 
     directly or indirectly (including by being a party to a 
     licensing agreement or other agreement), to--
       ``(A) discriminate by charging a higher price for a 
     prescription drug sold to a registered exporter or other 
     person in a permitted country that exports a qualifying drug 
     to the United States under this section than the price that 
     is charged, inclusive of rebates or other incentives to the 
     permitted country or other person, to another person that is 
     in the same country and that does not export a qualifying 
     drug into the United States under this section;
       ``(B) discriminate by charging a higher price for a 
     prescription drug sold to a registered importer or other 
     person that distributes, sells, or uses a qualifying drug 
     imported into the United States under this section than the 
     price that is charged to another person in the United States 
     that does not import a qualifying drug under this section, or 
     that does not distribute, sell, or use such a drug;
       ``(C) discriminate by denying, restricting, or delaying 
     supplies of a prescription drug to a registered exporter or 
     other person in a permitted country that exports a qualifying 
     drug to the United States under this section or to a 
     registered importer or other person that distributes, sells, 
     or uses a qualifying drug imported into the United States 
     under this section;
       ``(D) discriminate by publicly, privately, or otherwise 
     refusing to do business with a registered exporter or other 
     person in a permitted country that exports a qualifying drug 
     to the United States under this section

[[Page 10781]]

     or with a registered importer or other person that 
     distributes, sells, or uses a qualifying drug imported into 
     the United States under this section;
       ``(E) knowingly fail to submit a notice under subsection 
     (g)(2)(B)(i), knowingly fail to submit such a notice on or 
     before the date specified in subsection (g)(2)(B)(v) or as 
     otherwise required under subsection (e) (3), (4), and (5) of 
     section 4 of the Pharmaceutical Market Access and Drug Safety 
     Act of 2007, knowingly submit such a notice that makes a 
     materially false, fictitious, or fraudulent statement, or 
     knowingly fail to provide promptly any information requested 
     by the Secretary to review such a notice;
       ``(F) knowingly fail to submit an application required 
     under subsection (g)(2)(F), knowingly fail to submit such an 
     application on or before the date specified in subsection 
     (g)(2)(F)(ii), knowingly submit such an application that 
     makes a materially false, fictitious, or fraudulent 
     statement, or knowingly fail to provide promptly any 
     information requested by the Secretary to review such an 
     application;
       ``(G) cause there to be a difference (including a 
     difference in active ingredient, route of administration, 
     dosage form, strength, formulation, manufacturing 
     establishment, manufacturing process, or person that 
     manufactures the drug) between a prescription drug for 
     distribution in the United States and the drug for 
     distribution in a permitted country;
       ``(H) refuse to allow an inspection authorized under this 
     section of an establishment that manufactures a qualifying 
     drug that is, or will be, introduced for commercial 
     distribution in a permitted country;
       ``(I) fail to conform to the methods used in, or the 
     facilities used for, the manufacturing, processing, packing, 
     or holding of a qualifying drug that is, or will be, 
     introduced for commercial distribution in a permitted country 
     to good manufacturing practice under this Act;
       ``(J) become a party to a licensing agreement or other 
     agreement related to a qualifying drug that fails to provide 
     for compliance with all requirements of this section with 
     respect to such drug;
       ``(K) enter into a contract that restricts, prohibits, or 
     delays the importation of a qualifying drug under this 
     section;
       ``(L) engage in any other action to restrict, prohibit, or 
     delay the importation of a qualifying drug under this 
     section; or
       ``(M) engage in any other action that the Federal Trade 
     Commission determines to discriminate against a person that 
     engages or attempts to engage in the importation of a 
     qualifying drug under this section.
       ``(2) Referral of potential violations.--The Secretary 
     shall promptly refer to the Federal Trade Commission each 
     potential violation of subparagraph (E), (F), (G), (H), or 
     (I) of paragraph (1) that becomes known to the Secretary.
       ``(3) Affirmative defense.--
       ``(A) Discrimination.--It shall be an affirmative defense 
     to a charge that a manufacturer has discriminated under 
     subparagraph (A), (B), (C), (D), or (M) of paragraph (1) that 
     the higher price charged for a prescription drug sold to a 
     person, the denial, restriction, or delay of supplies of a 
     prescription drug to a person, the refusal to do business 
     with a person, or other discriminatory activity against a 
     person, is not based, in whole or in part, on--
       ``(i) the person exporting or importing a qualifying drug 
     into the United States under this section; or
       ``(ii) the person distributing, selling, or using a 
     qualifying drug imported into the United States under this 
     section.
       ``(B) Drug differences.--It shall be an affirmative defense 
     to a charge that a manufacturer has caused there to be a 
     difference described in subparagraph (G) of paragraph (1) 
     that--
       ``(i) the difference was required by the country in which 
     the drug is distributed;
       ``(ii) the Secretary has determined that the difference was 
     necessary to improve the safety or effectiveness of the drug;
       ``(iii) the person manufacturing the drug for distribution 
     in the United States has given notice to the Secretary under 
     subsection (g)(2)(B)(i) that the drug for distribution in the 
     United States is not different from a drug for distribution 
     in permitted countries whose combined population represents 
     at least 50 percent of the total population of all permitted 
     countries; or
       ``(iv) the difference was not caused, in whole or in part, 
     for the purpose of restricting importation of the drug into 
     the United States under this section.
       ``(4) Effect of subsection.--
       ``(A) Sales in other countries.--This subsection applies 
     only to the sale or distribution of a prescription drug in a 
     country if the manufacturer of the drug chooses to sell or 
     distribute the drug in the country. Nothing in this 
     subsection shall be construed to compel the manufacturer of a 
     drug to distribute or sell the drug in a country.
       ``(B) Discounts to insurers, health plans, pharmacy benefit 
     managers, and covered entities.--Nothing in this subsection 
     shall be construed to--
       ``(i) prevent or restrict a manufacturer of a prescription 
     drug from providing discounts to an insurer, health plan, 
     pharmacy benefit manager in the United States, or covered 
     entity in the drug discount program under section 340B of the 
     Public Health Service Act (42 U.S.C. 256b) in return for 
     inclusion of the drug on a formulary;
       ``(ii) require that such discounts be made available to 
     other purchasers of the prescription drug; or
       ``(iii) prevent or restrict any other measures taken by an 
     insurer, health plan, or pharmacy benefit manager to 
     encourage consumption of such prescription drug.
       ``(C) Charitable contributions.--Nothing in this subsection 
     shall be construed to--
       ``(i) prevent a manufacturer from donating a prescription 
     drug, or supplying a prescription drug at nominal cost, to a 
     charitable or humanitarian organization, including the United 
     Nations and affiliates, or to a government of a foreign 
     country; or
       ``(ii) apply to such donations or supplying of a 
     prescription drug.
       ``(5) Enforcement.--
       ``(A) Unfair or deceptive act or practice.--A violation of 
     this subsection shall be treated as a violation of a rule 
     defining an unfair or deceptive act or practice prescribed 
     under section 18(a)(1)(B) of the Federal Trade Commission Act 
     (15 U.S.C. 57a(a)(1)(B)).
       ``(B) Actions by the commission.--The Federal Trade 
     Commission--
       ``(i) shall enforce this subsection in the same manner, by 
     the same means, and with the same jurisdiction, powers, and 
     duties as though all applicable terms and provisions of the 
     Federal Trade Commission Act (15 U.S.C. 41 et seq.) were 
     incorporated into and made a part of this section; and
       ``(ii) may seek monetary relief threefold the damages 
     sustained, in addition to any other remedy available to the 
     Federal Trade Commission under the Federal Trade Commission 
     Act (15 U.S.C. 41 et seq.).
       ``(6) Actions by states.--
       ``(A) In general.--
       ``(i) Civil actions.--In any case in which the attorney 
     general of a State has reason to believe that an interest of 
     the residents of that State have been adversely affected by 
     any manufacturer that violates paragraph (1), the attorney 
     general of a State may bring a civil action on behalf of the 
     residents of the State, and persons doing business in the 
     State, in a district court of the United States of 
     appropriate jurisdiction to--

       ``(I) enjoin that practice;
       ``(II) enforce compliance with this subsection;
       ``(III) obtain damages, restitution, or other compensation 
     on behalf of residents of the State and persons doing 
     business in the State, including threefold the damages; or
       ``(IV) obtain such other relief as the court may consider 
     to be appropriate.

       ``(ii) Notice.--

       ``(I) In general.--Before filing an action under clause 
     (i), the attorney general of the State involved shall provide 
     to the Federal Trade Commission--

       ``(aa) written notice of that action; and
       ``(bb) a copy of the complaint for that action.

       ``(II) Exemption.--Subclause (I) shall not apply with 
     respect to the filing of an action by an attorney general of 
     a State under this paragraph, if the attorney general 
     determines that it is not feasible to provide the notice 
     described in that subclause before filing of the action. In 
     such case, the attorney general of a State shall provide 
     notice and a copy of the complaint to the Federal Trade 
     Commission at the same time as the attorney general files the 
     action.

       ``(B) Intervention.--
       ``(i) In general.--On receiving notice under subparagraph 
     (A)(ii), the Federal Trade Commission shall have the right to 
     intervene in the action that is the subject of the notice.
       ``(ii) Effect of intervention.--If the Federal Trade 
     Commission intervenes in an action under subparagraph (A), it 
     shall have the right--

       ``(I) to be heard with respect to any matter that arises in 
     that action; and
       ``(II) to file a petition for appeal.

       ``(C) Construction.--For purposes of bringing any civil 
     action under subparagraph (A), nothing in this subsection 
     shall be construed to prevent an attorney general of a State 
     from exercising the powers conferred on the attorney general 
     by the laws of that State to--
       ``(i) conduct investigations;
       ``(ii) administer oaths or affirmations; or
       ``(iii) compel the attendance of witnesses or the 
     production of documentary and other evidence.
       ``(D) Actions by the commission.--In any case in which an 
     action is instituted by or on behalf of the Federal Trade 
     Commission for a violation of paragraph (1), a State may not, 
     during the pendency of that action, institute an action under 
     subparagraph (A) for the same violation against any defendant 
     named in the complaint in that action.
       ``(E) Venue.--Any action brought under subparagraph (A) may 
     be brought in the district court of the United States that 
     meets applicable requirements relating to venue under section 
     1391 of title 28, United States Code.
       ``(F) Service of process.--In an action brought under 
     subparagraph (A), process may be served in any district in 
     which the defendant--
       ``(i) is an inhabitant; or

[[Page 10782]]

       ``(ii) may be found.
       ``(G) Measurement of damages.--In any action under this 
     paragraph to enforce a cause of action under this subsection 
     in which there has been a determination that a defendant has 
     violated a provision of this subsection, damages may be 
     proved and assessed in the aggregate by statistical or 
     sampling methods, by the computation of illegal overcharges 
     or by such other reasonable system of estimating aggregate 
     damages as the court in its discretion may permit without the 
     necessity of separately proving the individual claim of, or 
     amount of damage to, persons on whose behalf the suit was 
     brought.
       ``(H) Exclusion on duplicative relief.--The district court 
     shall exclude from the amount of monetary relief awarded in 
     an action under this paragraph brought by the attorney 
     general of a State any amount of monetary relief which 
     duplicates amounts which have been awarded for the same 
     injury.
       ``(7) Effect on antitrust laws.--Nothing in this subsection 
     shall be construed to modify, impair, or supersede the 
     operation of the antitrust laws. For the purpose of this 
     subsection, the term `antitrust laws' has the meaning given 
     it in the first section of the Clayton Act, except that it 
     includes section 5 of the Federal Trade Commission Act to the 
     extent that such section 5 applies to unfair methods of 
     competition.
       ``(8) Manufacturer.--In this subsection, the term 
     `manufacturer' means any entity, including any affiliate or 
     licensee of that entity, that is engaged in--
       ``(A) the production, preparation, propagation, 
     compounding, conversion, or processing of a prescription 
     drug, either directly or indirectly by extraction from 
     substances of natural origin, or independently by means of 
     chemical synthesis, or by a combination of extraction and 
     chemical synthesis; or
       ``(B) the packaging, repackaging, labeling, relabeling, or 
     distribution of a prescription drug.''.
       (b) Prohibited Acts.--The Federal Food, Drug, and Cosmetic 
     Act is amended--
       (1) in section 301 (21 U.S.C. 331), by striking paragraph 
     (aa) and inserting the following:
       ``(aa)(1) The sale or trade by a pharmacist, or by a 
     business organization of which the pharmacist is a part, of a 
     qualifying drug that under section 804(a)(2)(A) was imported 
     by the pharmacist, other than--
       ``(A) a sale at retail made pursuant to dispensing the drug 
     to a customer of the pharmacist or organization; or
       ``(B) a sale or trade of the drug to a pharmacy or a 
     wholesaler registered to import drugs under section 804.
       ``(2) The sale or trade by an individual of a qualifying 
     drug that under section 804(a)(2)(B) was imported by the 
     individual.
       ``(3) The making of a materially false, fictitious, or 
     fraudulent statement or representation, or a material 
     omission, in a notice under clause (i) of section 
     804(g)(2)(B) or in an application required under section 
     804(g)(2)(F), or the failure to submit such a notice or 
     application.
       ``(4) The importation of a drug in violation of a 
     registration condition or other requirement under section 
     804, the falsification of any record required to be 
     maintained, or provided to the Secretary, under such section, 
     or the violation of any registration condition or other 
     requirement under such section.''; and
       (2) in section 303(a) (21 U.S.C. 333(a)), by striking 
     paragraph (6) and inserting the following:
       ``(6) Notwithstanding subsection (a), any person that 
     knowingly violates section 301(i) (2) or (3) or section 
     301(aa)(4) shall be imprisoned not more than 10 years, or 
     fined in accordance with title 18, United States Code, or 
     both.''.
       (c) Amendment of Certain Provisions.--
       (1) In general.--Section 801 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 381) is amended by striking 
     subsection (g) and inserting the following:
       ``(g) With respect to a prescription drug that is imported 
     or offered for import into the United States by an individual 
     who is not in the business of such importation, that is not 
     shipped by a registered exporter under section 804, and that 
     is refused admission under subsection (a), the Secretary 
     shall notify the individual that--
       ``(1) the drug has been refused admission because the drug 
     was not a lawful import under section 804;
       ``(2) the drug is not otherwise subject to a waiver of the 
     requirements of subsection (a);
       ``(3) the individual may under section 804 lawfully import 
     certain prescription drugs from exporters registered with the 
     Secretary under section 804; and
       ``(4) the individual can find information about such 
     importation, including a list of registered exporters, on the 
     Internet website of the Food and Drug Administration or 
     through a toll-free telephone number required under section 
     804.''.
       (2) Establishment registration.--Section 510(i) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(i)) is 
     amended in paragraph (1) by inserting after ``import into the 
     United States'' the following: ``, including a drug that is, 
     or may be, imported or offered for import into the United 
     States under section 804,''.
       (3) Effective date.--The amendments made by this subsection 
     shall take effect on the date that is 90 days after the date 
     of enactment of this title.
       (d) Exhaustion.--
       (1) In general.--Section 271 of title 35, United States 
     Code, is amended--
       (A) by redesignating subsections (h) and (i) as (i) and 
     (j), respectively; and
       (B) by inserting after subsection (g) the following:
       ``(h) It shall not be an act of infringement to use, offer 
     to sell, or sell within the United States or to import into 
     the United States any patented invention under section 804 of 
     the Federal Food, Drug, and Cosmetic Act that was first sold 
     abroad by or under authority of the owner or licensee of such 
     patent.''.
       (2) Rule of construction.--Nothing in the amendment made by 
     paragraph (1) shall be construed to affect the ability of a 
     patent owner or licensee to enforce their patent, subject to 
     such amendment.
       (e) Effect of Section 804.--
       (1) In general.--Section 804 of the Federal Food, Drug, and 
     Cosmetic Act, as added by subsection (a), shall permit the 
     importation of qualifying drugs (as defined in such section 
     804) into the United States without regard to the status of 
     the issuance of implementing regulations--
       (A) from exporters registered under such section 804 on the 
     date that is 90 days after the date of enactment of this 
     title; and
       (B) from permitted countries, as defined in such section 
     804, by importers registered under such section 804 on the 
     date that is 1 year after the date of enactment of this 
     title.
       (2) Review of registration by certain exporters.--
       (A) Review priority.--In the review of registrations 
     submitted under subsection (b) of such section 804, 
     registrations submitted by entities in Canada that are 
     significant exporters of prescription drugs to individuals in 
     the United States as of the date of enactment of this title 
     will have priority during the 90 day period that begins on 
     such date of enactment.
       (B) Period for review.--During such 90-day period, the 
     reference in subsection (b)(2)(A) of such section 804 to 90 
     days (relating to approval or disapproval of registrations) 
     is, as applied to such entities, deemed to be 30 days.
       (C) Limitation.--That an exporter in Canada exports, or has 
     exported, prescription drugs to individuals in the United 
     States on or before the date that is 90 days after the date 
     of enactment of this title shall not serve as a basis, in 
     whole or in part, for disapproving a registration under such 
     section 804 from the exporter.
       (D) First year limit on number of exporters.--During the 1-
     year period beginning on the date of enactment of this title, 
     the Secretary of Health and Human Services (referred to in 
     this section as the ``Secretary'') may limit the number of 
     registered exporters under such section 804 to not less than 
     50, so long as the Secretary gives priority to those 
     exporters with demonstrated ability to process a high volume 
     of shipments of drugs to individuals in the United States.
       (E) Second year limit on number of exporters.--During the 
     1-year period beginning on the date that is 1 year after the 
     date of enactment of this title, the Secretary may limit the 
     number of registered exporters under such section 804 to not 
     less than 100, so long as the Secretary gives priority to 
     those exporters with demonstrated ability to process a high 
     volume of shipments of drugs to individuals in the United 
     States.
       (F) Further limit on number of exporters.--During any 1-
     year period beginning on a date that is 2 or more years after 
     the date of enactment of this title, the Secretary may limit 
     the number of registered exporters under such section 804 to 
     not less than 25 more than the number of such exporters 
     during the previous 1-year period, so long as the Secretary 
     gives priority to those exporters with demonstrated ability 
     to process a high volume of shipments of drugs to individuals 
     in the United States.
       (3) Limits on number of importers.--
       (A) First year limit on number of importers.--During the 1-
     year period beginning on the date that is 1 year after the 
     date of enactment of this title, the Secretary may limit the 
     number of registered importers under such section 804 to not 
     less than 100 (of which at least a significant number shall 
     be groups of pharmacies, to the extent feasible given the 
     applications submitted by such groups), so long as the 
     Secretary gives priority to those importers with demonstrated 
     ability to process a high volume of shipments of drugs 
     imported into the United States.
       (B) Second year limit on number of importers.--During the 
     1-year period beginning on the date that is 2 years after the 
     date of enactment of this title, the Secretary may limit the 
     number of registered importers under such section 804 to not 
     less than 200 (of which at least a significant number shall 
     be groups of pharmacies, to the extent feasible given the 
     applications submitted by such groups), so long as the 
     Secretary gives priority to those importers with demonstrated 
     ability to process a high volume of shipments of drugs into 
     the United States.
       (C) Further limit on number of importers.--During any 1-
     year period beginning on

[[Page 10783]]

     a date that is 3 or more years after the date of enactment of 
     this title, the Secretary may limit the number of registered 
     importers under such section 804 to not less than 50 more (of 
     which at least a significant number shall be groups of 
     pharmacies, to the extent feasible given the applications 
     submitted by such groups) than the number of such importers 
     during the previous 1-year period, so long as the Secretary 
     gives priority to those importers with demonstrated ability 
     to process a high volume of shipments of drugs to the United 
     States.
       (4) Notices for drugs for import from canada.--The notice 
     with respect to a qualifying drug introduced for commercial 
     distribution in Canada as of the date of enactment of this 
     title that is required under subsection (g)(2)(B)(i) of such 
     section 804 shall be submitted to the Secretary not later 
     than 30 days after the date of enactment of this title if--
       (A) the U.S. label drug (as defined in such section 804) 
     for the qualifying drug is 1 of the 100 prescription drugs 
     with the highest dollar volume of sales in the United States 
     based on the 12 calendar month period most recently completed 
     before the date of enactment of this Act; or
       (B) the notice is a notice under subsection 
     (g)(2)(B)(i)(II) of such section 804.
       (5) Notice for drugs for import from other countries.--The 
     notice with respect to a qualifying drug introduced for 
     commercial distribution in a permitted country other than 
     Canada as of the date of enactment of this title that is 
     required under subsection (g)(2)(B)(i) of such section 804 
     shall be submitted to the Secretary not later than 180 days 
     after the date of enactment of this title if--
       (A) the U.S. label drug for the qualifying drug is 1 of the 
     100 prescription drugs with the highest dollar volume of 
     sales in the United States based on the 12 calendar month 
     period that is first completed on the date that is 120 days 
     after the date of enactment of this title; or
       (B) the notice is a notice under subsection 
     (g)(2)(B)(i)(II) of such section 804.
       (6) Notice for other drugs for import.--
       (A) Guidance on submission dates.--The Secretary shall by 
     guidance establish a series of submission dates for the 
     notices under subsection (g)(2)(B)(i) of such section 804 
     with respect to qualifying drugs introduced for commercial 
     distribution as of the date of enactment of this title and 
     that are not required to be submitted under paragraph (4) or 
     (5).
       (B) Consistent and efficient use of resources.--The 
     Secretary shall establish the dates described under 
     subparagraph (A) so that such notices described under 
     subparagraph (A) are submitted and reviewed at a rate that 
     allows consistent and efficient use of the resources and 
     staff available to the Secretary for such reviews. The 
     Secretary may condition the requirement to submit such a 
     notice, and the review of such a notice, on the submission by 
     a registered exporter or a registered importer to the 
     Secretary of a notice that such exporter or importer intends 
     to import such qualifying drug to the United States under 
     such section 804.
       (C) Priority for drugs with higher sales.--The Secretary 
     shall establish the dates described under subparagraph (A) so 
     that the Secretary reviews the notices described under such 
     subparagraph with respect to qualifying drugs with higher 
     dollar volume of sales in the United States before the 
     notices with respect to drugs with lower sales in the United 
     States.
       (7) Notices for drugs approved after effective date.--The 
     notice required under subsection (g)(2)(B)(i) of such section 
     804 for a qualifying drug first introduced for commercial 
     distribution in a permitted country (as defined in such 
     section 804) after the date of enactment of this title shall 
     be submitted to and reviewed by the Secretary as provided 
     under subsection (g)(2)(B) of such section 804, without 
     regard to paragraph (4), (5), or (6).
       (8) Report.--Beginning with the first full fiscal year 
     after the date of enactment of this title, not later than 90 
     days after the end of each fiscal year during which the 
     Secretary reviews a notice referred to in paragraph (4), (5), 
     or (6), the Secretary shall submit a report to Congress 
     concerning the progress of the Food and Drug Administration 
     in reviewing the notices referred to in paragraphs (4), (5), 
     and (6).
       (9) User fees.--
       (A) Exporters.--When establishing an aggregate total of 
     fees to be collected from exporters under subsection (f)(2) 
     of such section 804, the Secretary shall, under subsection 
     (f)(3)(C)(i) of such section 804, estimate the total price of 
     drugs imported under subsection (a) of such section 804 into 
     the United States by registered exporters during the first 
     fiscal year in which this title takes effect to be an amount 
     equal to the amount which bears the same ratio to 
     $1,000,000,000 as the number of days in such fiscal year 
     during which this title is effective bears to 365.
       (B) Importers.--When establishing an aggregate total of 
     fees to be collected from importers under subsection (e)(2) 
     of such section 804, the Secretary shall, under subsection 
     (e)(3)(C)(i) of such section 804, estimate the total price of 
     drugs imported under subsection (a) of such section 804 into 
     the United States by registered importers during--
       (i) the first fiscal year in which this title takes effect 
     to be an amount equal to the amount which bears the same 
     ratio to $1,000,000,000 as the number of days in such fiscal 
     year during which this title is effective bears to 365; and
       (ii) the second fiscal year in which this title is in 
     effect to be $3,000,000,000.
       (C) Second year adjustment.--
       (i) Reports.--Not later than February 20 of the second 
     fiscal year in which this title is in effect, registered 
     importers shall report to the Secretary the total price and 
     the total volume of drugs imported to the United States by 
     the importer during the 4-month period from October 1 through 
     January 31 of such fiscal year.
       (ii) Reestimate.--Notwithstanding subsection (e)(3)(C)(ii) 
     of such section 804 or subparagraph (B), the Secretary shall 
     reestimate the total price of qualifying drugs imported under 
     subsection (a) of such section 804 into the United States by 
     registered importers during the second fiscal year in which 
     this title is in effect. Such reestimate shall be equal to--

       (I) the total price of qualifying drugs imported by each 
     importer as reported under clause (i); multiplied by
       (II) 3.

       (iii) Adjustment.--The Secretary shall adjust the fee due 
     on April 1 of the second fiscal year in which this title is 
     in effect, from each importer so that the aggregate total of 
     fees collected under subsection (e)(2) for such fiscal year 
     does not exceed the total price of qualifying drugs imported 
     under subsection (a) of such section 804 into the United 
     States by registered importers during such fiscal year as 
     reestimated under clause (ii).
       (D) Failure to pay fees.--Notwithstanding any other 
     provision of this section, the Secretary may prohibit a 
     registered importer or exporter that is required to pay user 
     fees under subsection (e) or (f) of such section 804 and that 
     fails to pay such fees within 30 days after the date on which 
     it is due, from importing or offering for importation a 
     qualifying drug under such section 804 until such fee is 
     paid.
       (E) Annual report.--
       (i) Food and drug administration.--Not later than 180 days 
     after the end of each fiscal year during which fees are 
     collected under subsection (e), (f), or (g)(2)(B)(iv) of such 
     section 804, the Secretary shall prepare and submit to the 
     House of Representatives and the Senate a report on the 
     implementation of the authority for such fees during such 
     fiscal year and the use, by the Food and Drug Administration, 
     of the fees collected for the fiscal year for which the 
     report is made and credited to the Food and Drug 
     Administration.
       (ii) Customs and border control.--Not later than 180 days 
     after the end of each fiscal year during which fees are 
     collected under subsection (e) or (f) of such section 804, 
     the Secretary of Homeland Security, in consultation with the 
     Secretary of the Treasury, shall prepare and submit to the 
     House of Representatives and the Senate a report on the use, 
     by the Bureau of Customs and Border Protection, of the fees, 
     if any, transferred by the Secretary to the Bureau of Customs 
     and Border Protection for the fiscal year for which the 
     report is made.
       (10) Special rule regarding importation by individuals.--
       (A) In general.--Notwithstanding any provision of this 
     title (or an amendment made by this title), the Secretary 
     shall expedite the designation of any additional countries 
     from which an individual may import a qualifying drug into 
     the United States under such section 804 if any action 
     implemented by the Government of Canada has the effect of 
     limiting or prohibiting the importation of qualifying drugs 
     into the United States from Canada.
       (B) Timing and criteria.--The Secretary shall designate 
     such additional countries under subparagraph (A)--
       (i) not later than 6 months after the date of the action by 
     the Government of Canada described under such subparagraph; 
     and
       (ii) using the criteria described under subsection 
     (a)(4)(D)(i)(II) of such section 804.
       (f) Implementation of Section 804.--
       (1) Interim rule.--The Secretary may promulgate an interim 
     rule for implementing section 804 of the Federal Food, Drug, 
     and Cosmetic Act, as added by subsection (a) of this section.
       (2) No notice of proposed rulemaking.--The interim rule 
     described under paragraph (1) may be developed and 
     promulgated by the Secretary without providing general notice 
     of proposed rulemaking.
       (3) Final rule.--Not later than 1 year after the date on 
     which the Secretary promulgates an interim rule under 
     paragraph (1), the Secretary shall, in accordance with 
     procedures under section 553 of title 5, United States Code, 
     promulgate a final rule for implementing such section 804, 
     which may incorporate by reference provisions of the interim 
     rule provided for under paragraph (1), to the extent that 
     such provisions are not modified.
       (g) Consumer Education.--The Secretary shall carry out 
     activities that educate consumers--
       (1) with regard to the availability of qualifying drugs for 
     import for personal use from an exporter registered with and 
     approved by the Food and Drug Administration under

[[Page 10784]]

     section 804 of the Federal Food, Drug, and Cosmetic Act, as 
     added by this section, including information on how to verify 
     whether an exporter is registered and approved by use of the 
     Internet website of the Food and Drug Administration and the 
     toll-free telephone number required by this title;
       (2) that drugs that consumers attempt to import from an 
     exporter that is not registered with and approved by the Food 
     and Drug Administration can be seized by the United States 
     Customs Service and destroyed, and that such drugs may be 
     counterfeit, unapproved, unsafe, or ineffective;
       (3) with regard to the suspension and termination of any 
     registration of a registered importer or exporter under such 
     section 804; and
       (4) with regard to the availability at domestic retail 
     pharmacies of qualifying drugs imported under such section 
     804 by domestic wholesalers and pharmacies registered with 
     and approved by the Food and Drug Administration.
       (h) Effect on Administration Practices.--Notwithstanding 
     any provision of this title (and the amendments made by this 
     title), the practices and policies of the Food and Drug 
     Administration and Bureau of Customs and Border Protection, 
     in effect on January 1, 2004, with respect to the importation 
     of prescription drugs into the United States by an 
     individual, on the person of such individual, for personal 
     use, shall remain in effect.
       (i) Report to Congress.--The Federal Trade Commission 
     shall, on an annual basis, submit to Congress a report that 
     describes any action taken during the period for which the 
     report is being prepared to enforce the provisions of section 
     804(n) of the Federal Food, Drug, and Cosmetic Act (as added 
     by this title), including any pending investigations or civil 
     actions under such section.

     SEC. _05. DISPOSITION OF CERTAIN DRUGS DENIED ADMISSION INTO 
                   UNITED STATES.

       (a) In General.--Chapter VIII of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 381 et seq.), as amended by 
     section _04, is further amended by adding at the end the 
     following section:

     ``SEC. 805. DISPOSITION OF CERTAIN DRUGS DENIED ADMISSION.

       ``(a) In General.--The Secretary of Homeland Security shall 
     deliver to the Secretary a shipment of drugs that is imported 
     or offered for import into the United States if--
       ``(1) the shipment has a declared value of less than 
     $10,000; and
       ``(2)(A) the shipping container for such drugs does not 
     bear the markings required under section 804(d)(2); or
       ``(B) the Secretary has requested delivery of such shipment 
     of drugs.
       ``(b) No Bond or Export.--Section 801(b) does not authorize 
     the delivery to the owner or consignee of drugs delivered to 
     the Secretary under subsection (a) pursuant to the execution 
     of a bond, and such drugs may not be exported.
       ``(c) Destruction of Violative Shipment.--The Secretary 
     shall destroy a shipment of drugs delivered by the Secretary 
     of Homeland Security to the Secretary under subsection (a) 
     if--
       ``(1) in the case of drugs that are imported or offered for 
     import from a registered exporter under section 804, the 
     drugs are in violation of any standard described in section 
     804(g)(5); or
       ``(2) in the case of drugs that are not imported or offered 
     for import from a registered exporter under section 804, the 
     drugs are in violation of a standard referred to in section 
     801(a) or 801(d)(1).
       ``(d) Certain Procedures.--
       ``(1) In general.--The delivery and destruction of drugs 
     under this section may be carried out without notice to the 
     importer, owner, or consignee of the drugs except as required 
     by section 801(g) or section 804(i)(2). The issuance of 
     receipts for the drugs, and recordkeeping activities 
     regarding the drugs, may be carried out on a summary basis.
       ``(2) Objective of procedures.--Procedures promulgated 
     under paragraph (1) shall be designed toward the objective of 
     ensuring that, with respect to efficiently utilizing Federal 
     resources available for carrying out this section, a 
     substantial majority of shipments of drugs subject to 
     described in subsection (c) are identified and destroyed.
       ``(e) Evidence Exception.--Drugs may not be destroyed under 
     subsection (c) to the extent that the Attorney General of the 
     United States determines that the drugs should be preserved 
     as evidence or potential evidence with respect to an offense 
     against the United States.
       ``(f) Rule of Construction.--This section may not be 
     construed as having any legal effect on applicable law with 
     respect to a shipment of drugs that is imported or offered 
     for import into the United States and has a declared value 
     equal to or greater than $10,000.''.
       (b) Procedures.--Procedures for carrying out section 805 of 
     the Federal Food, Drug, and Cosmetic Act, as added by 
     subsection (a), shall be established not later than 90 days 
     after the date of the enactment of this title.
       (c) Effective Date.--The amendments made by this section 
     shall take effect on the date that is 90 days after the date 
     of enactment of this title.

     SEC. _06. WHOLESALE DISTRIBUTION OF DRUGS; STATEMENTS 
                   REGARDING PRIOR SALE, PURCHASE, OR TRADE.

       (a) Striking of Exemptions; Applicability to Registered 
     Exporters.--Section 503(e) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 353(e)) is amended--
       (1) in paragraph (1)--
       (A) by striking ``and who is not the manufacturer or an 
     authorized distributor of record of such drug'';
       (B) by striking ``to an authorized distributor of record 
     or''; and
       (C) by striking subparagraph (B) and inserting the 
     following:
       ``(B) The fact that a drug subject to subsection (b) is 
     exported from the United States does not with respect to such 
     drug exempt any person that is engaged in the business of the 
     wholesale distribution of the drug from providing the 
     statement described in subparagraph (A) to the person that 
     receives the drug pursuant to the export of the drug.
       ``(C)(i) The Secretary shall by regulation establish 
     requirements that supersede subparagraph (A) (referred to in 
     this subparagraph as `alternative requirements') to identify 
     the chain of custody of a drug subject to subsection (b) from 
     the manufacturer of the drug throughout the wholesale 
     distribution of the drug to a pharmacist who intends to sell 
     the drug at retail if the Secretary determines that the 
     alternative requirements, which may include standardized 
     anti-counterfeiting or track-and-trace technologies, will 
     identify such chain of custody or the identity of the 
     discrete package of the drug from which the drug is dispensed 
     with equal or greater certainty to the requirements of 
     subparagraph (A), and that the alternative requirements are 
     economically and technically feasible.
       ``(ii) When the Secretary promulgates a final rule to 
     establish such alternative requirements, the final rule in 
     addition shall, with respect to the registration condition 
     established in clause (i) of section 804(c)(3)(B), establish 
     a condition equivalent to the alternative requirements, and 
     such equivalent condition may be met in lieu of the 
     registration condition established in such clause (i).'';
       (2) in paragraph (2)(A), by adding at the end the 
     following: ``The preceding sentence may not be construed as 
     having any applicability with respect to a registered 
     exporter under section 804.''; and
       (3) in paragraph (3), by striking ``and subsection (d)--'' 
     in the matter preceding subparagraph (A) and all that follows 
     through ``the term `wholesale distribution' means'' in 
     subparagraph (B) and inserting the following: ``and 
     subsection (d), the term `wholesale distribution' means''.
       (b) Conforming Amendment.--Section 503(d) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 353(d)) is amended by 
     adding at the end the following:
       ``(4) Each manufacturer of a drug subject to subsection (b) 
     shall maintain at its corporate offices a current list of the 
     authorized distributors of record of such drug.
       ``(5) For purposes of this subsection, the term `authorized 
     distributors of record' means those distributors with whom a 
     manufacturer has established an ongoing relationship to 
     distribute such manufacturer's products.''.
       (c) Effective Date.--
       (1) In general.--The amendments made by paragraphs (1) and 
     (3) of subsection (a) and by subsection (b) shall take effect 
     on January 1, 2010.
       (2) Drugs imported by registered importers under section 
     804.--Notwithstanding paragraph (1), the amendments made by 
     paragraphs (1) and (3) of subsection (a) and by subsection 
     (b) shall take effect on the date that is 90 days after the 
     date of enactment of this title with respect to qualifying 
     drugs imported under section 804 of the Federal Food, Drug, 
     and Cosmetic Act, as added by section _04.
       (3) Effect with respect to registered exporters.--The 
     amendment made by subsection (a)(2) shall take effect on the 
     date that is 90 days after the date of enactment of this 
     title.
       (4) Alternative requirements.--The Secretary shall issue 
     regulations to establish the alternative requirements, 
     referred to in the amendment made by subsection (a)(1), that 
     take effect not later than January 1, 2010.
       (5) Intermediate requirements.--The Secretary shall by 
     regulation require the use of standardized anti-
     counterfeiting or track-and-trace technologies on 
     prescription drugs at the case and pallet level effective not 
     later than 1 year after the date of enactment of this title.
       (6) Additional requirements.--
       (A) In general.--Notwithstanding any other provision of 
     this section, the Secretary shall, not later than 18 months 
     after the date of enactment of this title, require that the 
     packaging of any prescription drug incorporates--
       (i) a standardized numerical identifier unique to each 
     package of such drug, applied at the point of manufacturing 
     and repackaging (in which case the numerical identifier shall 
     be linked to the numerical identifier applied at the point of 
     manufacturing); and
       (ii)(I) overt optically variable counterfeit-resistant 
     technologies that--

[[Page 10785]]

       (aa) are visible to the naked eye, providing for visual 
     identification of product authenticity without the need for 
     readers, microscopes, lighting devices, or scanners;
       (bb) are similar to that used by the Bureau of Engraving 
     and Printing to secure United States currency;
       (cc) are manufactured and distributed in a highly secure, 
     tightly controlled environment; and
       (dd) incorporate additional layers of nonvisible convert 
     security features up to and including forensic capability, as 
     described in subparagraph (B); or

       (II) technologies that have a function of security 
     comparable to that described in subclause (I), as determined 
     by the Secretary.
       (B) Standards for packaging.--For the purpose of making it 
     more difficult to counterfeit the packaging of drugs subject 
     to this paragraph, the manufacturers of such drugs shall 
     incorporate the technologies described in subparagraph (A) 
     into at least 1 additional element of the physical packaging 
     of the drugs, including blister packs, shrink wrap, package 
     labels, package seals, bottles, and boxes.

     SEC. _07. INTERNET SALES OF PRESCRIPTION DRUGS.

       (a) In General.--Chapter V of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting 
     after section 503A the following:

     ``SEC. 503B. INTERNET SALES OF PRESCRIPTION DRUGS.

       ``(a) Requirements Regarding Information on Internet 
     Site.--
       ``(1) In general.--A person may not dispense a prescription 
     drug pursuant to a sale of the drug by such person if--
       ``(A) the purchaser of the drug submitted the purchase 
     order for the drug, or conducted any other part of the sales 
     transaction for the drug, through an Internet site;
       ``(B) the person dispenses the drug to the purchaser by 
     mailing or shipping the drug to the purchaser; and
       ``(C) such site, or any other Internet site used by such 
     person for purposes of sales of a prescription drug, fails to 
     meet each of the requirements specified in paragraph (2), 
     other than a site or pages on a site that--
       ``(i) are not intended to be accessed by purchasers or 
     prospective purchasers; or
       ``(ii) provide an Internet information location tool within 
     the meaning of section 231(e)(5) of the Communications Act of 
     1934 (47 U.S.C. 231(e)(5)).
       ``(2) Requirements.--With respect to an Internet site, the 
     requirements referred to in subparagraph (C) of paragraph (1) 
     for a person to whom such paragraph applies are as follows:
       ``(A) Each page of the site shall include either the 
     following information or a link to a page that provides the 
     following information:
       ``(i) The name of such person.
       ``(ii) Each State in which the person is authorized by law 
     to dispense prescription drugs.
       ``(iii) The address and telephone number of each place of 
     business of the person with respect to sales of prescription 
     drugs through the Internet, other than a place of business 
     that does not mail or ship prescription drugs to purchasers.
       ``(iv) The name of each individual who serves as a 
     pharmacist for prescription drugs that are mailed or shipped 
     pursuant to the site, and each State in which the individual 
     is authorized by law to dispense prescription drugs.
       ``(v) If the person provides for medical consultations 
     through the site for purposes of providing prescriptions, the 
     name of each individual who provides such consultations; each 
     State in which the individual is licensed or otherwise 
     authorized by law to provide such consultations or practice 
     medicine; and the type or types of health professions for 
     which the individual holds such licenses or other 
     authorizations.
       ``(B) A link to which paragraph (1) applies shall be 
     displayed in a clear and prominent place and manner, and 
     shall include in the caption for the link the words 
     `licensing and contact information'.
       ``(b) Internet Sales Without Appropriate Medical 
     Relationships.--
       ``(1) In general.--Except as provided in paragraph (2), a 
     person may not dispense a prescription drug, or sell such a 
     drug, if--
       ``(A) for purposes of such dispensing or sale, the 
     purchaser communicated with the person through the Internet;
       ``(B) the patient for whom the drug was dispensed or 
     purchased did not, when such communications began, have a 
     prescription for the drug that is valid in the United States;
       ``(C) pursuant to such communications, the person provided 
     for the involvement of a practitioner, or an individual 
     represented by the person as a practitioner, and the 
     practitioner or such individual issued a prescription for the 
     drug that was purchased;
       ``(D) the person knew, or had reason to know, that the 
     practitioner or the individual referred to in subparagraph 
     (C) did not, when issuing the prescription, have a qualifying 
     medical relationship with the patient; and
       ``(E) the person received payment for the dispensing or 
     sale of the drug.
     For purposes of subparagraph (E), payment is received if 
     money or other valuable consideration is received.
       ``(2) Exceptions.--Paragraph (1) does not apply to--
       ``(A) the dispensing or selling of a prescription drug 
     pursuant to telemedicine practices sponsored by--
       ``(i) a hospital that has in effect a provider agreement 
     under title XVIII of the Social Security Act (relating to the 
     Medicare program); or
       ``(ii) a group practice that has not fewer than 100 
     physicians who have in effect provider agreements under such 
     title; or
       ``(B) the dispensing or selling of a prescription drug 
     pursuant to practices that promote the public health, as 
     determined by the Secretary by regulation.
       ``(3) Qualifying medical relationship.--
       ``(A) In general.--With respect to issuing a prescription 
     for a drug for a patient, a practitioner has a qualifying 
     medical relationship with the patient for purposes of this 
     section if--
       ``(i) at least one in-person medical evaluation of the 
     patient has been conducted by the practitioner; or
       ``(ii) the practitioner conducts a medical evaluation of 
     the patient as a covering practitioner.
       ``(B) In-person medical evaluation.--A medical evaluation 
     by a practitioner is an in-person medical evaluation for 
     purposes of this section if the practitioner is in the 
     physical presence of the patient as part of conducting the 
     evaluation, without regard to whether portions of the 
     evaluation are conducted by other health professionals.
       ``(C) Covering practitioner.--With respect to a patient, a 
     practitioner is a covering practitioner for purposes of this 
     section if the practitioner conducts a medical evaluation of 
     the patient at the request of a practitioner who has 
     conducted at least one in-person medical evaluation of the 
     patient and is temporarily unavailable to conduct the 
     evaluation of the patient. A practitioner is a covering 
     practitioner without regard to whether the practitioner has 
     conducted any in-person medical evaluation of the patient 
     involved.
       ``(4) Rules of construction.--
       ``(A) Individuals represented as practitioners.--A person 
     who is not a practitioner (as defined in subsection (e)(1)) 
     lacks legal capacity under this section to have a qualifying 
     medical relationship with any patient.
       ``(B) Standard practice of pharmacy.--Paragraph (1) may not 
     be construed as prohibiting any conduct that is a standard 
     practice in the practice of pharmacy.
       ``(C) Applicability of requirements.--Paragraph (3) may not 
     be construed as having any applicability beyond this section, 
     and does not affect any State law, or interpretation of State 
     law, concerning the practice of medicine.
       ``(c) Actions by States.--
       ``(1) In general.--Whenever an attorney general of any 
     State has reason to believe that the interests of the 
     residents of that State have been or are being threatened or 
     adversely affected because any person has engaged or is 
     engaging in a pattern or practice that violates section 
     301(l), the State may bring a civil action on behalf of its 
     residents in an appropriate district court of the United 
     States to enjoin such practice, to enforce compliance with 
     such section (including a nationwide injunction), to obtain 
     damages, restitution, or other compensation on behalf of 
     residents of such State, to obtain reasonable attorneys fees 
     and costs if the State prevails in the civil action, or to 
     obtain such further and other relief as the court may deem 
     appropriate.
       ``(2) Notice.--The State shall serve prior written notice 
     of any civil action under paragraph (1) or (5)(B) upon the 
     Secretary and provide the Secretary with a copy of its 
     complaint, except that if it is not feasible for the State to 
     provide such prior notice, the State shall serve such notice 
     immediately upon instituting such action. Upon receiving a 
     notice respecting a civil action, the Secretary shall have 
     the right--
       ``(A) to intervene in such action;
       ``(B) upon so intervening, to be heard on all matters 
     arising therein; and
       ``(C) to file petitions for appeal.
       ``(3) Construction.--For purposes of bringing any civil 
     action under paragraph (1), nothing in this chapter shall 
     prevent an attorney general of a State from exercising the 
     powers conferred on the attorney general by the laws of such 
     State to conduct investigations or to administer oaths or 
     affirmations or to compel the attendance of witnesses or the 
     production of documentary and other evidence.
       ``(4) Venue; service of process.--Any civil action brought 
     under paragraph (1) in a district court of the United States 
     may be brought in the district in which the defendant is 
     found, is an inhabitant, or transacts business or wherever 
     venue is proper under section 1391 of title 28, United States 
     Code. Process in such an action may be served in any district 
     in which the defendant is an inhabitant or in which the 
     defendant may be found.
       ``(5) Actions by other state officials.--
       ``(A) Nothing contained in this section shall prohibit an 
     authorized State official from proceeding in State court on 
     the basis of an alleged violation of any civil or criminal 
     statute of such State.
       ``(B) In addition to actions brought by an attorney general 
     of a State under paragraph

[[Page 10786]]

     (1), such an action may be brought by officers of such State 
     who are authorized by the State to bring actions in such 
     State on behalf of its residents.
       ``(d) Effect of Section.--This section shall not apply to a 
     person that is a registered exporter under section 804.
       ``(e) General Definitions.--For purposes of this section:
       ``(1) The term `practitioner' means a practitioner referred 
     to in section 503(b)(1) with respect to issuing a written or 
     oral prescription.
       ``(2) The term `prescription drug' means a drug that is 
     described in section 503(b)(1).
       ``(3) The term `qualifying medical relationship', with 
     respect to a practitioner and a patient, has the meaning 
     indicated for such term in subsection (b).
       ``(f) Internet-Related Definitions.--
       ``(1) In general.--For purposes of this section:
       ``(A) The term `Internet' means collectively the myriad of 
     computer and telecommunications facilities, including 
     equipment and operating software, which comprise the 
     interconnected world-wide network of networks that employ the 
     transmission control protocol/internet protocol, or any 
     predecessor or successor protocols to such protocol, to 
     communicate information of all kinds by wire or radio.
       ``(B) The term `link', with respect to the Internet, means 
     one or more letters, words, numbers, symbols, or graphic 
     items that appear on a page of an Internet site for the 
     purpose of serving, when activated, as a method for executing 
     an electronic command--
       ``(i) to move from viewing one portion of a page on such 
     site to another portion of the page;
       ``(ii) to move from viewing one page on such site to 
     another page on such site; or
       ``(iii) to move from viewing a page on one Internet site to 
     a page on another Internet site.
       ``(C) The term `page', with respect to the Internet, means 
     a document or other file accessed at an Internet site.
       ``(D)(i) The terms `site' and `address', with respect to 
     the Internet, mean a specific location on the Internet that 
     is determined by Internet Protocol numbers. Such term 
     includes the domain name, if any.
       ``(ii) The term `domain name' means a method of 
     representing an Internet address without direct reference to 
     the Internet Protocol numbers for the address, including 
     methods that use designations such as `.com', `.edu', `.gov', 
     `.net', or `.org'.
       ``(iii) The term `Internet Protocol numbers' includes any 
     successor protocol for determining a specific location on the 
     Internet.
       ``(2) Authority of secretary.--The Secretary may by 
     regulation modify any definition under paragraph (1) to take 
     into account changes in technology.
       ``(g) Interactive Computer Service; Advertising.--No 
     provider of an interactive computer service, as defined in 
     section 230(f)(2) of the Communications Act of 1934 (47 
     U.S.C. 230(f)(2)), or of advertising services shall be liable 
     under this section for dispensing or selling prescription 
     drugs in violation of this section on account of another 
     person's selling or dispensing such drugs, provided that the 
     provider of the interactive computer service or of 
     advertising services does not own or exercise corporate 
     control over such person.''.
       (b) Inclusion as Prohibited Act.--Section 301 of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is 
     amended by inserting after paragraph (k) the following:
       ``(l) The dispensing or selling of a prescription drug in 
     violation of section 503B.''.
       (c) Internet Sales of Prescription Drugs; Consideration by 
     Secretary of Practices and Procedures for Certification of 
     Legitimate Businesses.--In carrying out section 503B of the 
     Federal Food, Drug, and Cosmetic Act (as added by subsection 
     (a) of this section), the Secretary of Health and Human 
     Services shall take into consideration the practices and 
     procedures of public or private entities that certify that 
     businesses selling prescription drugs through Internet sites 
     are legitimate businesses, including practices and procedures 
     regarding disclosure formats and verification programs.
       (d) Reports Regarding Internet-Related Violations of 
     Federal and State Laws on Dispensing of Drugs.--
       (1) In general.--The Secretary of Health and Human Services 
     (referred to in this subsection as the ``Secretary'') shall, 
     pursuant to the submission of an application meeting the 
     criteria of the Secretary, make an award of a grant or 
     contract to the National Clearinghouse on Internet 
     Prescribing (operated by the Federation of State Medical 
     Boards) for the purpose of--
       (A) identifying Internet sites that appear to be in 
     violation of Federal or State laws concerning the dispensing 
     of drugs;
       (B) reporting such sites to State medical licensing boards 
     and State pharmacy licensing boards, and to the Attorney 
     General and the Secretary, for further investigation; and
       (C) submitting, for each fiscal year for which the award 
     under this subsection is made, a report to the Secretary 
     describing investigations undertaken with respect to 
     violations described in subparagraph (A).
       (2) Authorization of appropriations.--For the purpose of 
     carrying out paragraph (1), there is authorized to be 
     appropriated $100,000 for each of the first 3 fiscal years in 
     which this section is in effect.
       (e) Effective Date.--The amendments made by subsections (a) 
     and (b) take effect 90 days after the date of enactment of 
     this title, without regard to whether a final rule to 
     implement such amendments has been promulgated by the 
     Secretary of Health and Human Services under section 701(a) 
     of the Federal Food, Drug, and Cosmetic Act. The preceding 
     sentence may not be construed as affecting the authority of 
     such Secretary to promulgate such a final rule.

     SEC. _08. PROHIBITING PAYMENTS TO UNREGISTERED FOREIGN 
                   PHARMACIES.

       (a) In General.--Section 303 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 333) is amended by adding at the end 
     the following:
       ``(g) Restricted Transactions.--
       ``(1) In general.--The introduction of restricted 
     transactions into a payment system or the completion of 
     restricted transactions using a payment system is prohibited.
       ``(2) Payment system.--
       ``(A) In general.--The term `payment system' means a system 
     used by a person described in subparagraph (B) to effect a 
     credit transaction, electronic fund transfer, or money 
     transmitting service that may be used in connection with, or 
     to facilitate, a restricted transaction, and includes--
       ``(i) a credit card system;
       ``(ii) an international, national, regional, or local 
     network used to effect a credit transaction, an electronic 
     fund transfer, or a money transmitting service; and
       ``(iii) any other system that is centrally managed and is 
     primarily engaged in the transmission and settlement of 
     credit transactions, electronic fund transfers, or money 
     transmitting services.
       ``(B) Persons described.--A person referred to in 
     subparagraph (A) is--
       ``(i) a creditor;
       ``(ii) a credit card issuer;
       ``(iii) a financial institution;
       ``(iv) an operator of a terminal at which an electronic 
     fund transfer may be initiated;
       ``(v) a money transmitting business; or
       ``(vi) a participant in an international, national, 
     regional, or local network used to effect a credit 
     transaction, electronic fund transfer, or money transmitting 
     service.
       ``(3) Restricted transaction.--The term `restricted 
     transaction' means a transaction or transmittal, on behalf of 
     an individual who places an unlawful drug importation request 
     to any person engaged in the operation of an unregistered 
     foreign pharmacy, of--
       ``(A) credit, or the proceeds of credit, extended to or on 
     behalf of the individual for the purpose of the unlawful drug 
     importation request (including credit extended through the 
     use of a credit card);
       ``(B) an electronic fund transfer or funds transmitted by 
     or through a money transmitting business, or the proceeds of 
     an electronic fund transfer or money transmitting service, 
     from or on behalf of the individual for the purpose of the 
     unlawful drug importation request;
       ``(C) a check, draft, or similar instrument which is drawn 
     by or on behalf of the individual for the purpose of the 
     unlawful drug importation request and is drawn on or payable 
     at or through any financial institution; or
       ``(D) the proceeds of any other form of financial 
     transaction (identified by the Board by regulation) that 
     involves a financial institution as a payor or financial 
     intermediary on behalf of or for the benefit of the 
     individual for the purpose of the unlawful drug importation 
     request.
       ``(4) Unlawful drug importation request.--The term 
     `unlawful drug importation request' means the request, or 
     transmittal of a request, made to an unregistered foreign 
     pharmacy for a prescription drug by mail (including a private 
     carrier), facsimile, phone, or electronic mail, or by a means 
     that involves the use, in whole or in part, of the Internet.
       ``(5) Unregistered foreign pharmacy.--The term 
     `unregistered foreign pharmacy' means a person in a country 
     other than the United States that is not a registered 
     exporter under section 804.
       ``(6) Other definitions.--
       ``(A) Credit; creditor; credit card.--The terms `credit', 
     `creditor', and `credit card' have the meanings given the 
     terms in section 103 of the Truth in Lending Act (15 U.S.C. 
     1602).
       ``(B) Access device; electronic fund transfer.--The terms 
     `access device' and `electronic fund transfer'--
       ``(i) have the meaning given the term in section 903 of the 
     Electronic Fund Transfer Act (15 U.S.C. 1693a); and
       ``(ii) the term `electronic fund transfer' also includes 
     any fund transfer covered under Article 4A of the Uniform 
     Commercial Code, as in effect in any State.
       ``(C) Financial institution.--The term `financial 
     institution'--
       ``(i) has the meaning given the term in section 903 of the 
     Electronic Transfer Fund Act (15 U.S.C. 1693a); and
       ``(ii) includes a financial institution (as defined in 
     section 509 of the Gramm-Leach-Bliley Act (15 U.S.C. 6809)).
       ``(D) Money transmitting business; money transmitting 
     service.--The terms `money

[[Page 10787]]

     transmitting business' and `money transmitting service' have 
     the meaning given the terms in section 5330(d) of title 31, 
     United States Code.
       ``(E) Board.--The term `Board' means the Board of Governors 
     of the Federal Reserve System.
       ``(7) Policies and procedures required to prevent 
     restricted transactions.--
       ``(A) Regulations.--The Board shall promulgate regulations 
     requiring--
       ``(i) an operator of a credit card system;
       ``(ii) an operator of an international, national, regional, 
     or local network used to effect a credit transaction, an 
     electronic fund transfer, or a money transmitting service;
       ``(iii) an operator of any other payment system that is 
     centrally managed and is primarily engaged in the 
     transmission and settlement of credit transactions, 
     electronic transfers or money transmitting services where at 
     least one party to the transaction or transfer is an 
     individual; and
       ``(iv) any other person described in paragraph (2)(B) and 
     specified by the Board in such regulations,

     to establish policies and procedures that are reasonably 
     designed to prevent the introduction of a restricted 
     transaction into a payment system or the completion of a 
     restricted transaction using a payment system
       ``(B) Requirements for policies and procedures.--In 
     promulgating regulations under subparagraph (A), the Board 
     shall--
       ``(i) identify types of policies and procedures, including 
     nonexclusive examples, that shall be considered to be 
     reasonably designed to prevent the introduction of restricted 
     transactions into a payment system or the completion of 
     restricted transactions using a payment system; and
       ``(ii) to the extent practicable, permit any payment 
     system, or person described in paragraph (2)(B), as 
     applicable, to choose among alternative means of preventing 
     the introduction or completion of restricted transactions.
       ``(C) No liability for blocking or refusing to honor 
     restricted transaction.--
       ``(i) In general.--A payment system, or a person described 
     in paragraph (2)(B) that is subject to a regulation issued 
     under this subsection, and any participant in such payment 
     system that prevents or otherwise refuses to honor 
     transactions in an effort to implement the policies and 
     procedures required under this subsection or to otherwise 
     comply with this subsection shall not be liable to any party 
     for such action.
       ``(ii) Compliance.--A person described in paragraph (2)(B) 
     meets the requirements of this subsection if the person 
     relies on and complies with the policies and procedures of a 
     payment system of which the person is a member or in which 
     the person is a participant, and such policies and procedures 
     of the payment system comply with the requirements of the 
     regulations promulgated under subparagraph (A).
       ``(D) Enforcement.--
       ``(i) In general.--This section shall be enforced by the 
     Federal functional regulators and the Federal Trade 
     Commission under applicable law in the manner provided in 
     section 505(a) of the Gramm-Leach-Bliley Act (15 U.S.C. 
     6805(a)).
       ``(ii) Factors to be considered.--In considering any 
     enforcement action under this subsection against a payment 
     system or person described in paragraph (2)(B), the Federal 
     functional regulators and the Federal Trade Commission shall 
     consider the following factors:

       ``(I) The extent to which the payment system or person 
     knowingly permits restricted transactions.
       ``(II) The history of the payment system or person in 
     connection with permitting restricted transactions.
       ``(III) The extent to which the payment system or person 
     has established and is maintaining policies and procedures in 
     compliance with regulations prescribed under this subsection.

       ``(8) Transactions permitted.--A payment system, or a 
     person described in paragraph (2)(B) that is subject to a 
     regulation issued under this subsection, is authorized to 
     engage in transactions with foreign pharmacies in connection 
     with investigating violations or potential violations of any 
     rule or requirement adopted by the payment system or person 
     in connection with complying with paragraph (7). A payment 
     system, or such a person, and its agents and employees shall 
     not be found to be in violation of, or liable under, any 
     Federal, State or other law by virtue of engaging in any such 
     transaction.
       ``(9) Relation to state laws.--No requirement, prohibition, 
     or liability may be imposed on a payment system, or a person 
     described in paragraph (2)(B) that is subject to a regulation 
     issued under this subsection, under the laws of any state 
     with respect to any payment transaction by an individual 
     because the payment transaction involves a payment to a 
     foreign pharmacy.
       ``(10) Timing of requirements.--A payment system, or a 
     person described in paragraph (2)(B) that is subject to a 
     regulation issued under this subsection, must adopt policies 
     and procedures reasonably designed to comply with any 
     regulations required under paragraph (7) within 60 days after 
     such regulations are issued in final form.''.
       (b) Effective Date.--The amendment made by this section 
     shall take effect on the day that is 90 days after the date 
     of enactment of this Act.
       (c) Implementation.--The Board of Governors of the Federal 
     Reserve System shall promulgate regulations as required by 
     subsection (g)(7) of section 303 of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 333), as added by subsection (a), 
     not later than 90 days after the date of enactment of this 
     title.

     SEC. _09. IMPORTATION EXEMPTION UNDER CONTROLLED SUBSTANCES 
                   IMPORT AND EXPORT ACT.

       Section 1006(a)(2) of the Controlled Substances Import and 
     Export Act (21 U.S.C. 956(a)(2)) is amended by striking ``not 
     import the controlled substance into the United States in an 
     amount that exceeds 50 dosage units of the controlled 
     substance.'' and inserting ``import into the United States 
     not more than 10 dosage units combined of all such controlled 
     substances.''.

     SEC. _10. SEVERABILITY.

       If any provision of this title, an amendment by this title, 
     or the application of such provision or amendment to any 
     person or circumstance is held to be unconstitutional, the 
     remainder of this title, the amendments made by this title, 
     and the application of the provisions of such to any person 
     or circumstance shall not affected thereby.
                                 ______
                                 
  SA 991. Mr. KOHL (for himself, Mr. Grassley, Mr. Leahy, and Mr. 
Schumer) submitted an amendment intended to be proposed by him to the 
bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to 
reauthorize and amend the prescription drug user fee provisions, and 
for other purposes; which was ordered to lie on the table; as follows:

       At the end of the bill, insert the following:

           TITLE__PRESERVE ACCESS TO AFFORDABLE GENERICS ACT

     SEC. _01. SHORT TITLE.

       This title may be cited as the ``Preserve Access to 
     Affordable Generics Act''.

     SEC. _02. CONGRESSIONAL FINDINGS AND DECLARATION OF PURPOSES.

       (a) Findings.--The Congress finds that--
       (1) prescription drugs make up 11 percent of the national 
     health care spending but are 1 of the largest and fastest 
     growing health care expenditures;
       (2) 56 percent of all prescriptions dispensed in the United 
     States are generic drugs, yet they account for only 13percent 
     of all expenditures;
       (3) generic drugs, on average, cost 63 percent less than 
     their brand-name counterparts;
       (4) consumers and the health care system would benefit from 
     free and open competition in the pharmaceutical market and 
     the removal of obstacles to the introduction of generic 
     drugs;
       (5) full and free competition in the pharmaceutical 
     industry, and the full enforcement of antitrust law to 
     prevent anticompetitive practices in this industry, will lead 
     to lower prices, greater innovation, and inure to the general 
     benefit of consumers.
       (6) the Federal Trade Commission has determined that some 
     brand name pharmaceutical manufacturers collude with generic 
     drug manufacturers to delay the marketing of competing, low-
     cost, generic drugs;
       (7) collusion by the brand name pharmaceutical 
     manufacturers is contrary to free competition, to the 
     interests of consumers, and to the principles underlying 
     antitrust law;
       (8) in 2005, 2 appellate court decisions reversed the 
     Federal Trade Commission's long-standing position, and upheld 
     settlements that include pay-offs by brand name 
     pharmaceutical manufacturers to generic manufacturers 
     designed to keep generic competition off the market;
       (9) in the 6 months following the March 2005 court 
     decisions, the Federal Trade Commission found there were 
     three settlement agreements in which the generic received 
     compensation and agreed to a restriction on its ability to 
     market the product;
       (10) the FTC found that more than \2/3\ of the 
     approximately ten settlement agreements made in 2006 include 
     a pay-off from the brand in exchange for a promise by the 
     generic company to delay entry into the market; and
       (11) settlements which include a payment from a brand name 
     manufacturer to a generic manufacturer to delay entry by 
     generic drugs are anti-competitive and contrary to the 
     interests of consumers.
       (b) Purposes.--The purposes of this title are--
       (1) to enhance competition in the pharmaceutical market by 
     prohibiting anticompetitive agreements and collusion between 
     brand name and generic drug manufacturers intended to keep 
     generic drugs off the market;
       (2) to support the purpose and intent of antitrust law by 
     prohibiting anticompetitive agreements and collusion in the 
     pharmaceutical industry; and
       (3) to clarify the law to prohibit payments from brand name 
     to generic drug manufacturers with the purpose to prevent or 
     delay the entry of competition from generic drugs.

[[Page 10788]]



     SEC. 3. UNLAWFUL COMPENSATION FOR DELAY.

       (a) In General.--The Clayton Act (15 U.S.C. 12 et seq.) is 
     amended by inserting after section 28 the following:

     ``SEC. 29. UNLAWFUL INTERFERENCE WITH GENERIC MARKETING.

       ``(a) It shall be unlawful under this Act for any person, 
     in connection with the sale of a drug product, to directly or 
     indirectly be a party to any agreement resolving or settling 
     a patent infringement claim which--
       ``(1) an ANDA filer receives anything of value; and
       ``(2) the ANDA filer agrees not to research, develop, 
     manufacture, market, or sell the ANDA product for any period 
     of time.
       ``(b) Nothing in this section shall prohibit a resolution 
     or settlement of patent infringement claim in which the value 
     paid by the NDA holder to the ANDA filer as a part of the 
     resolution or settlement of the patent infringement claim 
     includes no more than the right to market the ANDA product 
     prior to the expiration of the patent that is the basis for 
     the patent infringement claim.
       ``(c) In this section:
       ``(1) The term `agreement' means anything that would 
     constitute an agreement under section 1 of the Sherman Act 
     (15 U.S.C. 1) or section 5 of the Federal Trade Commission 
     Act (15 U.S.C. 45).
       ``(2) The term `agreement resolving or settling a patent 
     infringement claim' includes, any agreement that is 
     contingent upon, provides a contingent condition for, or is 
     otherwise related to the resolution or settlement of the 
     claim.
       ``(3) The term `ANDA' means an abbreviated new drug 
     application, as defined under section 505(j) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)).
       ``(4) The term `ANDA filer' means a party who has filed an 
     ANDA with the Federal Drug Administration.
       ``(5) The term `ANDA product' means the product to be 
     manufactured under the ANDA that is the subject of the patent 
     infringement claim.
       ``(6) The term `drug product' means a finished dosage form 
     (e.g., tablet, capsule, or solution) that contains a drug 
     substance, generally, but not necessarily, in association 
     with 1 or more other ingredients, as defined in section 
     314.3(b) of title 21, Code of Federal Regulations.
       ``(7) The term `NDA' means a new drug application, as 
     defined under section 505(b) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355(b)).
       ``(8) The term `NDA holder' means--
       ``(A) the party that received FDA approval to market a drug 
     product pursuant to an NDA;
       ``(B) a party owning or controlling enforcement of the 
     patent listed in the Approved Drug Products With Therapeutic 
     Equivalence Evaluations (commonly known as the `FDA Orange 
     Book') in connection with the NDA; or
       ``(C) the predecessors, subsidiaries, divisions, groups, 
     and affiliates controlled by, controlling, or under common 
     control with any of the entities described in subclauses (i) 
     and (ii) (such control to be presumed by direct or indirect 
     share ownership of 50 percent or greater), as well as the 
     licensees, licensors, successors, and assigns of each of the 
     entities.
       ``(9) The term `patent infringement' means infringement of 
     any patent or of any filed patent application, extension, 
     reissue, renewal, division, continuation, continuation in 
     part, reexamination, patent term restoration, patents of 
     addition and extensions thereof.
       ``(10) The term `patent infringement claim' means any 
     allegation made to an ANDA filer, whether or not included in 
     a complaint filed with a court of law, that its ANDA or ANDA 
     product may infringe any patent held by, or exclusively 
     licensed to, the NDA holder of the drug product.''.
       (b) Regulations.--The Federal Trade Commission may, by rule 
     promulgated under section 553 of title 5, United States Code, 
     exempt certain agreements described in the section 29 of the 
     Clayton Act, as added by subsection (a), if the Commission 
     finds such agreements to be in furtherance of market 
     competition and for the benefit of consumers. Consistent with 
     the authority of Commission, such rules may include 
     interpretive rules and general statements of policy with 
     respect to the practices prohibited under section 29 of the 
     Clayton Act.

     SEC. _04. NOTICE AND CERTIFICATION OF AGREEMENTS.

       (a) Notice of All Agreements.--Section 1112(c)(2) of the 
     Medicare Prescription Drug, Improvement, and Modernization 
     Act of 2003 (21 U.S.C. 3155 note) is amended by--
       (1) striking ``the Commission the'' and inserting ``the 
     Commission (1) the''; and
       (2) inserting before the period at the end the following: 
     ``; and (2) a description of the subject matter of any other 
     agreement the parties enter into within 30 days of an 
     entering into an agreement covered by subsection (a) or 
     (b)''.
       (b) Certification of Agreements.--Section 1112 of such Act 
     is amended by adding at the end the following:
       ``(d) Certification.--The Chief Executive Officer or the 
     company official responsible for negotiating any agreement 
     required to be filed under subsection (a), (b), or (c) shall 
     execute and file with the Assistant Attorney General and the 
     Commission a certification as follows: `I declare under 
     penalty of perjury that the following is true and correct: 
     The materials filed with the Federal Trade Commission and the 
     Department of Justice under section 1112 of subtitle B of 
     title XI of the Medicare Prescription Drug, Improvement, and 
     Modernization Act of 2003, with respect to the agreement 
     referenced in this certification: (1) represent the complete, 
     final, and exclusive agreement between the parties; (2) 
     include any ancillary agreements that are contingent upon, 
     provide a contingent condition for, or are otherwise related 
     to, the referenced agreement; and (3) include written 
     descriptions of any oral agreements, representations, 
     commitments, or promises between the parties that are 
     responsive to subsection (a) or (b) of such section 1112 and 
     have not been reduced to writing.'.''.

     SEC. _05. FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD.

       Section 505 of the Federal Food, Drug and Cosmetic Act (21 
     U.S.C. 355(j)(5)(D)(i)(V)) is amended by inserting ``section 
     28 of the Clayton Act or'' after ``that the agreement has 
     violated''.

     SEC. _06. STUDY BY THE FEDERAL TRADE COMMISSION.

       (a) Requirement for a Study.--Not later than 180 days after 
     the date of enactment of this Act and pursuant to its 
     authority under section 6(a) of the Federal Trade Commission 
     Act (15 U.S.C. 46(a)) and its jurisdiction to prevent unfair 
     methods of competition, the Federal Trade Commission shall 
     conduct a study regarding--
       (1) the prevalence of agreements in patent infringement 
     suits of the type described in section 29 of the Clayton Act, 
     as added by this title, during the last 5 years;
       (2) the impact of such agreements on competition in the 
     pharmaceutical market; and
       (3) the prevalence in the pharmaceutical industry of other 
     anticompetitive agreements among competitors or other 
     practices that are contrary to the antitrust laws, and the 
     impact of such agreements or practices on competition in the 
     pharmaceutical market during the last 5 years.
       (b) Consultation.--In conducting the study required under 
     this section, the Federal Trade Commission shall consult with 
     the Antitrust Division of the Department of Justice regarding 
     the Justice Department's findings and investigations 
     regarding anticompetitive practices in the pharmaceutical 
     market, including criminal antitrust investigations completed 
     by the Justice Department with respect to practices or 
     conduct in the pharmaceutical market.
       (c) Requirement for a Report.--Not later than 1 year after 
     the date of enactment of this Act, the Federal Trade 
     Commission shall submit a report to the Judiciary Committees 
     of Senate and House of Representatives, and to the Department 
     of Justice regarding the findings of the study conducted 
     under subsection (a). This report shall contain the Federal 
     Trade Commission's recommendation as to whether any amendment 
     to the antitrust laws should be enacted to correct any 
     substantial lessening of competition found during the study.
       (d) Federal Agency Consideration.--Upon receipt of the 
     report required by subsection (c), the Attorney General or 
     the Chairman of the Federal Trade Commission, as appropriate, 
     shall consider whether any additional enforcement action is 
     required to restore competition or prevent a substantial 
     lessening of competition occurring as a result of the conduct 
     or practices that were the subject of the study conducted 
     under subsection (b).

     SEC. _07. AUTHORIZATION OF APPROPRIATIONS.

       There are authorized to be appropriated to the Federal 
     Trade Commission such sums as may be necessary to carry out 
     the provisions of this title.

                                 ______
                                 
  SA 992. Mr. KOHL submitted an amendment intended to be proposed by 
him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic 
Act to reauthorize and amend the prescription drug user fee provisions, 
and for other purposes; which was ordered to lie on the table; as 
follows:

       At the appropriate place, insert the following:

     SEC. __. CITIZEN PETITIONS AND PETITIONS FOR STAY OF AGENCY 
                   ACTION.

       Section 505(j)(5) of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 355(j)(5)) is amended by adding at the end the 
     following:
       ``(G)(i) Notwithstanding any other provision of law, any 
     petition submitted under section 10.30 or section 10.35 of 
     title 21, Code of Federal Regulations (or any successor 
     regulation), shall include a statement that to the 
     petitioner's best knowledge and belief, the petition--
       ``(I) includes all information and views on which the 
     petitioner relies, including all representative data and 
     information known to the petitioner that is favorable or 
     unfavorable to the petition;
       ``(II) is well grounded in fact and is warranted by law;
       ``(III) is not submitted for an improper purpose, such as 
     to harass or cause unnecessary delay (including unnecessary 
     delay of competition or agency action); and
       ``(IV) does not contain a materially false, misleading, or 
     fraudulent statement.

[[Page 10789]]

       ``(ii) The Secretary shall investigate, on receipt of a 
     complaint, a request under clause (vi), or on its own 
     initiative, any petition submitted under such section 10.30 
     or section 10.35 (or any successor regulation), that--
       ``(I) does not comply with the requirements of clause (i);
       ``(II) may have been submitted for an improper purpose as 
     described in clause (i)(III); or
       ``(III) may contain a materially false, misleading, or 
     fraudulent statement as described in clause (i)(IV).
       ``(iii) If the Secretary finds that the petitioner has 
     knowingly and willingly submitted the petition for an 
     improper purpose as described in clause (i)(III), or which 
     contains a materially false, misleading, or fraudulent 
     statement as described in clause (i)(IV), the Secretary may--
       ``(I) impose a civil penalty of not more than $1,000,000, 
     plus attorneys fees and costs of reviewing the petition and 
     any related proceedings;
       ``(II) suspend the authority of the petitioner to submit a 
     petition under such section 10.30 or section 10.35 (or any 
     successor regulation), for a period of not more than 10 
     years;
       ``(III) revoke permanently the authority of the petitioner 
     to submit a petition under such section 10.30 or section 
     10.35 (or any successor regulation); or
       ``(IV) dismiss the petition at issue in its entirety.
       ``(iv) If the Secretary takes an enforcement action 
     described in subclause (I), (II), (III), or (IV) of clause 
     (iii) with respect to a petition, the Secretary shall refer 
     that petition to the Federal Trade Commission for further 
     action as the Federal Trade Commission finds appropriate.
       ``(v) In determining whether to take an enforcement action 
     described in subclause (I), (II), (III), or (IV) of clause 
     (iii) with respect to a petition, and in determining the 
     amount of any civil penalty or the length of any suspension 
     imposed under that clause, the Secretary shall consider the 
     specific circumstances of the situation, such as the gravity 
     and seriousness of the violation involved, the amount of 
     resources expended in reviewing the petition at issue, the 
     effect on marketing of competing drugs of the pendency of the 
     improperly submitted petition, including whether the timing 
     of the submission of the petition appears to have been 
     calculated to cause delay in the marketing of any drug 
     awaiting approval, and whether the petitioner has a history 
     of submitting petitions in violation of this subparagraph.
       ``(vi)(I) Any person aggrieved by a petition filed under 
     such section 10.30 or section 10.35 (or any successor 
     regulation), including a person filing an application under 
     subsection (b)(2) or (j) of this section to which such 
     petition relates, may request that the Secretary initiate an 
     investigation described under clause (ii) for an enforcement 
     action described under clause (iii).
       ``(II) The aggrieved person shall specify the basis for its 
     belief that the petition at issue is false, misleading, 
     fraudulent, or submitted for an improper purpose. The 
     aggrieved person shall certify that the request is submitted 
     in good faith, is well grounded in fact, and not submitted 
     for any improper purpose. Any aggrieved person who knowingly 
     and intentionally violates the preceding sentence shall be 
     subject to the civil penalty described under clause (iii)(I).
       ``(vii) The Secretary shall take final agency action with 
     respect to a petition filed under such section 10.30 or 
     section 10.35 (or any successor regulation) regarding an 
     abbreviated new drug application within 6 months of receipt 
     of such petition. The Secretary shall not extend such 6-month 
     review period, even with consent of the petitioner, for any 
     reason, including based upon the submission of comments 
     relating to a petition or supplemental information supplied 
     by the petitioner. If the Secretary has not taken final 
     agency action on a petition regarding an abbreviated new drug 
     application by the date that is 6 months after the date of 
     receipt of the petition, such petition shall be deemed to 
     have been denied on such date.
       ``(viii) The Secretary may promulgate regulations to carry 
     out this subparagraph, including to determine whether 
     petitions filed under such section 10.30 or section 10.35 (or 
     any successor regulation) merit enforcement action by the 
     Secretary under this subparagraph.''.
                                 ______
                                 
  SA 993. Mr. GREGG submitted an amendment intended to be proposed by 
him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic 
Act to reauthorize and amend the prescription drug user fee provisions, 
and for other purposes; which was ordered to lie on the table; as 
follows:

       At the appropriate place, insert the following:

                      TITLE _--INTERNET PHARMACIES

     SEC. _01. SHORT TITLE.

       This title may be cited as the ``Safe Internet Pharmacy Act 
     of 2007''.

     SEC. _02. INTERNET PHARMACIES.

       (a) Internet Pharmacies.--Chapter V of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by 
     inserting after section 510 the following:

     ``SEC. 511. INTERNET PHARMACIES.

       ``(a) Definitions.--In this section:
       ``(1) Advertising service provider.--The term `advertising 
     service provider' means an advertising company that contracts 
     with a provider of an interactive computer service (as 
     defined in section 230(f) of the Communications Act of 1934 
     (47 U.S.C. 230(f)) to provide advertising on the Internet.
       ``(2) Designated payment system.--
       ``(A) In general.--The term `designated payment system' 
     means a system used by a person described in subparagraph (B) 
     to effect a credit transaction, electronic fund transfer, or 
     money transmitting service that the Board determines, by 
     regulation or order, is regularly used in connection with, or 
     to facilitate restricted transactions.
       ``(B) Persons described.--A person referred to in 
     subparagraph (A) is--
       ``(i) a creditor;
       ``(ii) a credit card issuer;
       ``(iii) a financial institution;
       ``(iv) an operator of a terminal at which an electronic 
     fund transfer may be initiated;
       ``(v) a money transmitting business; or
       ``(vi) a participant in an international, national, 
     regional, or local network constructed primarily to effect a 
     credit transaction, electronic fund transfer, or money 
     transmitting service.
       ``(3) Federal functional regulator.--The term `Federal 
     functional regulator' has the meaning given the term in 
     section 509 of the Gramm-Leach-Bliley Act (15 U.S.C. 6809).
       ``(4) Internet pharmacy.--The term `Internet pharmacy' 
     means a person that offers to dispense or dispenses in the 
     United States a prescription drug through an Internet website 
     in interstate commerce, regardless of whether the physical 
     location of the principal place of business of the Internet 
     pharmacy is in the United States or in another country.
       ``(5) Prescription drug.--The term `prescription drug' 
     means a drug described in section 503(b) that is approved by 
     the Secretary under section 505.
       ``(6) Restricted transaction.--The term `restricted 
     transaction' means a transaction or transmittal, on behalf of 
     a individual who places an unlawful Internet pharmacy request 
     to any person engaged in the operation of an unlicensed 
     Internet pharmacy, of--
       ``(A) credit, or the proceeds of credit, extended to or on 
     behalf of the individual for the purpose of the unlawful 
     Internet request (including credit extended through the use 
     of a credit card);
       ``(B) an electronic fund transfer or funds transmitted by 
     or through a money transmitting business, or the proceeds of 
     an electronic fund transfer or money transmitting service, 
     from or on behalf of the individual for the purpose of the 
     unlawful Internet request;
       ``(C) a check, draft, or similar instrument which is drawn 
     by or on behalf of the individual for the purpose of the 
     unlawful Internet request and is drawn on or payable at or 
     through any financial institution; or
       ``(D) the proceeds of any other form of financial 
     transaction (identified by the Board by regulation) that 
     involves a financial institution as a payor or financial 
     intermediary on behalf of or for the benefit of the 
     individual for the purpose of the unlawful Internet request.
       ``(7) Treating provider.--The term `treating provider' 
     means a health care provider licensed in the United States 
     who is authorized to prescribe medications and who--
       ``(A)(i) performs a documented patient evaluation 
     (including a patient history and physical examination) of an 
     individual, portions of which may be conducted by other 
     health professionals;
       ``(ii) discusses with the individual the treatment options 
     of the individual and the risks and benefits of treatment; 
     and
       ``(iii) maintains contemporaneous medical records 
     concerning the individual; or
       ``(B) provides care to an individual as part of an on-call 
     or cross-coverage arrangement with a health care provider 
     described in subparagraph (A).
       ``(8) Unlawful internet pharmacy request.--The term 
     `unlawful Internet pharmacy request' means the request, or 
     transmittal of a request, made to an unlicensed Internet 
     pharmacy for a prescription drug by mail (including a private 
     carrier), facsimile, telephone, or electronic mail, or by a 
     means that involves the use, in whole or in part, of the 
     Internet.
       ``(9) Unlicensed internet pharmacy.--The term `unlicensed 
     Internet pharmacy' means an Internet pharmacy that is not 
     licensed under this section.
       ``(10) Other definitions.--
       ``(A) Board.--The term `Board' means the Board of Governors 
     of the Federal Reserve System.
       ``(B) Credit; creditor; credit card.--The terms `credit', 
     `creditor', and `credit card' have the meanings given the 
     terms in section 103 of the Truth in Lending Act (15 U.S.C. 
     1602).
       ``(C) Electronic fund transfer.--The term `electronic fund 
     transfer'--
       ``(i) has the meaning given the term in section 903 of the 
     Electronic Fund Transfer Act (15 U.S.C. 1693a); and

[[Page 10790]]

       ``(ii) includes any fund transfer covered under article 4A 
     of the Uniform Commercial Code, as in effect in any State.
       ``(D) Financial institution.--The term `financial 
     institution'--
       ``(i) has the meaning given the term in section 903 of the 
     Electronic Transfer Fund Act (15 U.S.C. 1693a); and
       ``(ii) includes a financial institution (as defined in 
     section 509 of the Gramm-Leach-Bliley Act (15 U.S.C. 6809)).
       ``(E) Money transmitting business; money transmitting 
     service.--The terms `money transmitting business' and `money 
     transmitting service' have the meanings given the terms in 
     section 5330(d) of title 31, United States Code.
       ``(b) In General.--An Internet pharmacy may only dispense 
     or offer to dispense a prescription drug to a person in the 
     United States in accordance with this section.
       ``(c) Licensing of Internet Pharmacies.--
       ``(1) In general.--An Internet pharmacy shall be licensed 
     by the Secretary in accordance with this section prior to 
     offering to dispense or dispensing a prescription drug to an 
     individual.
       ``(2) Conditions for licensing.--
       ``(A) Application requirements.--An Internet pharmacy shall 
     submit to the Secretary an application that includes--
       ``(i)(I) in the case of an Internet pharmacy located in the 
     United States, verification that, in each State in which the 
     Internet pharmacy engages in dispensing or offering to 
     dispense prescription drugs, the Internet pharmacy, and all 
     employees and agents of the Internet pharmacy, is in 
     compliance with applicable Federal and State laws regarding--

       ``(aa) the practice of pharmacy, including licensing laws 
     and inspection requirements; and
       ``(bb) the manufacturing and distribution of controlled 
     substances, including with respect to mailing or shipping 
     controlled substances to consumers; or

       ``(II) in the case of an Internet pharmacy whose principal 
     place of business is located outside the United States, 
     verification that--

       ``(aa) all employees and agents of the Internet pharmacy 
     are in compliance with applicable Federal and State laws 
     regarding the practice of pharmacy, including licensing laws 
     and inspection requirements;
       ``(bb) the Internet pharmacy is in compliance with 
     applicable Federal and State laws regarding the practice of 
     pharmacy, including licensing laws and inspection 
     requirements;
       ``(cc) the Internet pharmacy expressly and affirmatively 
     agrees to provide and maintain an agent for service of 
     process in the United States;
       ``(dd) the Internet pharmacy expressly and affirmatively 
     agrees to be subject to the jurisdiction of the United States 
     and any of its States or territories where it engages in 
     commerce; and
       ``(ee) the Internet pharmacy agrees to affix to each 
     shipping container of drugs to be shipped in the United 
     States such markings as the Secretary determines to be 
     necessary to identify that the shipment is from a licensed 
     Internet pharmacy, which may include anticounterfeiting or 
     track-and-trace technologies;

       ``(ii) verification that the person that owns the Internet 
     pharmacy has not had a license for an Internet pharmacy 
     terminated by the Secretary, and that no other Internet 
     pharmacy owned by the person has had a license under this 
     subsection that has been terminated by the Secretary;
       ``(iii) verification from the person that owns the Internet 
     pharmacy that the person will permit inspection of the 
     facilities and business practices of the Internet pharmacy by 
     the Secretary to the extent necessary to determine whether 
     the Internet pharmacy is in compliance with this subsection;
       ``(iv) in the case of an agreement between a patient and an 
     Internet pharmacy that releases the Internet pharmacy, and 
     any employee or agent of the Internet pharmacy, from 
     liability for damages arising out of the negligence of the 
     Internet pharmacy, an assurance that such a limitation of 
     liability shall be null and void;
       ``(v) verification that the Internet pharmacy expressly and 
     affirmatively agrees to provide the Secretary with the 
     identity of any providers of interactive computer services 
     that provide host services or advertising services for the 
     Internet pharmacy; and
       ``(vi) assurance that the Internet pharmacy will comply 
     with the requirements under subparagraphs (B) and (C).
       ``(B) Identification requirements.--An Internet pharmacy 
     shall post in a clear and visible manner, on each page of the 
     website of the Internet pharmacy or by a link to a separate 
     page, the following information:
       ``(i) The street address, city, ZIP Code or comparable mail 
     code, State (or comparable entity), country, and telephone 
     number of--

       ``(I) each place of business of the Internet pharmacy; and
       ``(II) the name of the supervising pharmacist of the 
     Internet pharmacy and each individual who serves as a 
     pharmacist for purposes of the Internet pharmacy website.

       ``(ii) The names of all States in which the Internet 
     pharmacy and the pharmacists employed by the Internet 
     pharmacy are licensed or otherwise authorized to dispense 
     prescription drugs.
       ``(iii) If the Internet pharmacy makes referrals to, or 
     solicits on behalf of, a health care practitioner or group of 
     practitioners in the United States for prescription 
     services--

       ``(I) the name, street address, city, ZIP Code or 
     comparable mail code, State, and telephone number of the 
     practitioner or group; and
       ``(II) the name of each State in which each practitioner is 
     licensed or otherwise authorized to prescribe drugs.

       ``(iv) A statement that the Internet pharmacy will dispense 
     prescription drugs only after receipt of a valid prescription 
     from a treating provider.
       ``(v) A distinctive tamper resistant seal to identify that 
     the Internet pharmacy is licensed.
       ``(C) Professional services requirements.--An Internet 
     pharmacy shall carry out the following:
       ``(i) Maintain patient medication profiles and other 
     related data in a readily accessible format organized to 
     facilitate consultation with treating providers, caregivers, 
     and patients.
       ``(ii) Conduct prospective drug use reviews before 
     dispensing medications or medical devices.
       ``(iii) Ensure patient confidentiality and the protection 
     of patient identity and patient-specific information, in 
     accordance with the regulations promulgated under section 
     264(c) of the Health Insurance Portability and Accountability 
     Act of 1996.
       ``(iv) Offer interactive and meaningful consultation by a 
     licensed pharmacist to the caregiver or patient before and 
     after the time at which the Internet pharmacy dispenses the 
     drug.
       ``(v)(I) Establish a mechanism for patients to report 
     errors and suspected adverse drug reactions.
       ``(II) Document in the reporting mechanism the response of 
     the Internet pharmacy to those reports.
       ``(III) Submit those reports within 3 days of receipt and 
     the response of the Internet pharmacy to the Food and Drug 
     Administration in a manner determined appropriate by the 
     Secretary.
       ``(vi) Develop a system to inform caregivers and patients 
     about drug recalls.
       ``(vii) Educate caregivers and patients about the 
     appropriate means of disposing of expired, damaged, or 
     unusable medications.
       ``(viii) Assure that the sale of a prescription drug is in 
     accordance with a valid prescription from the treating 
     provider of the individual.
       ``(ix)(I) Verify the validity of the prescription of an 
     individual by using 1 of the following methods:

       ``(aa) If the prescription for any drug other than a 
     controlled substance (as defined in section 102 of the 
     Controlled Substances Act (21 U.S.C. 802)) is received from 
     an individual or the treating provider of the individual by 
     mail (including a private carrier), or from the treating 
     provider of the individual by electronic mail, the validity 
     of the prescription shall be confirmed in accordance with all 
     applicable Federal and State laws.
       ``(bb) If the prescription is for a controlled substance 
     (as defined in section 102 of the Controlled Substances Act), 
     the validity of the prescription shall be confirmed with the 
     treating provider as described in subclause (II).

       ``(II) When seeking verification of a prescription of an 
     individual under subclause (I)(bb), an Internet pharmacy 
     shall provide to the treating provider the following 
     information:

       ``(aa) The full name and address of the individual.
       ``(bb) Identification of the prescription drug.
       ``(cc) The quantity of the prescription drug to be 
     dispensed.
       ``(dd) The date on which the individual presented the 
     prescription to the Internet pharmacy.
       ``(ee) The date and time of the verification request.
       ``(ff) The name of a contact person at the Internet 
     pharmacy, including a voice telephone number, electronic mail 
     address, and facsimile telephone number.

       ``(III) A prescription is verified under subclause (I)(bb) 
     only if 1 of the following occurs:

       ``(aa) The treating provider confirms, by direct 
     communication with the Internet pharmacy, that the 
     prescription is accurate.
       ``(bb) The treating provider informs the Internet pharmacy 
     that the prescription is inaccurate and provides the accurate 
     prescription.

       ``(IV) An Internet pharmacy shall not fill a prescription 
     if--

       ``(aa) a treating provider informs the Internet pharmacy 
     within 72 hours after receipt of a communication under 
     subclause (I)(bb) that the prescription is inaccurate or 
     expired; or
       ``(bb) the treating provider does not respond within that 
     time.

       ``(x) Maintain, for such period of time as the Secretary 
     shall prescribe by regulation, a record of all direct 
     communications with a treating provider regarding the 
     dispensing of a prescription drug, including verification of 
     the prescription.

[[Page 10791]]

       ``(3) Licensure procedure.--
       ``(A) Action by secretary.--On receipt of a complete 
     licensing application from an Internet pharmacy under 
     paragraph (2), the Secretary shall--
       ``(i) assign an identification number to the Internet 
     pharmacy;
       ``(ii) notify the applicant of the receipt of the licensing 
     application; and
       ``(iii) if the Internet pharmacy is in compliance with the 
     conditions under paragraph (2), issue a license not later 
     than 60 days after receipt of a licensing application from 
     the Internet pharmacy.
       ``(B) Electronic filing.--
       ``(i) In general.--For the purpose of reducing paperwork 
     and reporting burdens, the Secretary shall require the use of 
     electronic methods of submitting to the Secretary a licensing 
     application required under this section and provide for 
     electronic methods of receiving the applications.
       ``(ii) Authentication.--In providing for the electronic 
     submission of such licensing applications under this section, 
     the Secretary shall ensure that adequate authentication 
     protocols are used to allow identification of the Internet 
     pharmacy and validation of the data as appropriate.
       ``(4) Database.--
       ``(A) In general.--The Secretary shall compile, maintain, 
     and periodically update a database of the Internet pharmacies 
     licensed under this section.
       ``(B) Availability.--The Secretary shall make the database 
     described under subparagraph (A) and information submitted by 
     the licensee under paragraph (2)(B) available to the public 
     on an Internet website and through a toll-free telephone 
     number.
       ``(5) Fees.--
       ``(A) In general.--
       ``(i) Licensing application fee.--The Secretary shall 
     establish a licensing application fee to be paid by all 
     applicants.
       ``(ii) Renewal fee.--The Secretary shall establish a yearly 
     renewal fee to be paid by all Internet pharmacies licensed 
     under this section.
       ``(B) Collection.--
       ``(i) Collection of licensing application fee.--A licensing 
     application fee payable for the fiscal year in which the 
     Internet pharmacy submits a licensing application, as 
     established under subparagraph (C), shall be payable upon the 
     submission to the Secretary of such licensing application.
       ``(ii) Collection of renewal fees.--After the licensing 
     application fee is paid for the first fiscal year of 
     licensure, the yearly renewal fee, as established under 
     subparagraph (C), shall be payable on or before October 1 of 
     each subsequent fiscal year.
       ``(iii) One fee per internet pharmacy.--The licensing 
     application fee and yearly renewal fee shall be paid only 
     once for each Internet pharmacy for a fiscal year in which 
     the fee is payable.
       ``(C) Fee amount.--The amount of the licensing application 
     fee and the yearly renewal fee for an Internet pharmacy shall 
     be determined each year by the Secretary based on the 
     anticipated costs to the Secretary of enforcing the 
     requirements of this section in the subsequent fiscal year.
       ``(D) Annual fee determination.--
       ``(i) In general.--Not later than 60 days before the 
     beginning of each fiscal year beginning after September 30, 
     2007, the Secretary shall determine the amount of the 
     licensing application fee and the yearly renewal fee for that 
     fiscal year.
       ``(ii) Publication of fee amount.--Not later than 60 days 
     before each fiscal year, the Secretary shall publish the 
     amount of the licensing application fee and the yearly 
     renewal fee under this section for that fiscal year and 
     provide for a period of 30 days for the public to provide 
     written comments on the fees.
       ``(E) Use of fees.--The fees collected under this section 
     shall be used, without further appropriation, to carry out 
     this section.
       ``(F) Failure to pay fee.--
       ``(i) Due date.--A fee payable under this section shall be 
     paid by the date that is 30 days after the date on which the 
     fee is due.
       ``(ii) Failure to pay.--If an Internet pharmacy subject to 
     a fee under this section fails to pay the fee by the date 
     specified under clause (i), the Secretary shall not permit 
     the Internet pharmacy to engage in the dispensing of drugs as 
     described under this section until all such fees owed by the 
     Internet pharmacy are paid.
       ``(G) Reports.--Beginning with fiscal year 2008, not later 
     than 60 days after the end of each fiscal year during which 
     licensing application fees are collected under this section, 
     the Secretary shall submit to the Committee on Health, 
     Education, Labor, and Pensions of the Senate and the 
     Committee on Energy and Commerce of the House of 
     Representatives a report that describes--
       ``(i) implementation of the licensing fee authority during 
     the fiscal year; and
       ``(ii) the use by the Secretary of the licensing fees 
     collected during the fiscal year for which the report is 
     made.
       ``(6) Suspension.--
       ``(A) In general.--If the Secretary determines that an 
     Internet pharmacy is engaged in a pattern of violations of 
     any of the requirements of this Act, the Secretary may 
     immediately order the suspension of the license of the 
     Internet pharmacy.
       ``(B) Appeal of suspension order.--An Internet pharmacy 
     subject to a suspension order under subparagraph (A) may 
     appeal the suspension order to the Secretary. Not later than 
     30 days after an appeal is filed, the Secretary, after 
     providing opportunity for an informal hearing, shall affirm 
     or terminate the order.
       ``(C) Failure to act.--If, during the 30-day period 
     specified in subparagraph (B), the Secretary fails to provide 
     an opportunity for a hearing or to affirm or terminate the 
     order, the order shall be deemed to be terminated.
       ``(D) No judicial review.--An order under this paragraph 
     shall not be subject to judicial review.
       ``(7) Termination of license.--The Secretary may terminate 
     a license issued under this subsection, after notice to the 
     Internet pharmacy and an opportunity for a hearing, and if 
     the Secretary determines that the Internet pharmacy--
       ``(A) has demonstrated a pattern of noncompliance with this 
     section;
       ``(B) has made an untrue statement of material fact in its 
     licensing application; or
       ``(C) is in violation of any applicable Federal or State 
     law relating to the dispensing of a prescription drug.
       ``(8) Renewal evaluation.--
       ``(A) In general.--Before renewing a license of an Internet 
     pharmacy under this subsection, the Secretary shall conduct 
     an evaluation to determine whether the Internet pharmacy is 
     in compliance with this section.
       ``(B) Evaluation of internet pharmacies.--At the discretion 
     of the Secretary and as applicable, an evaluation under 
     subparagraph (A) may include testing of the Internet pharmacy 
     website or other systems through which the Internet pharmacy 
     communicates with consumers, and a physical inspection of the 
     records and premises of the pharmacy.
       ``(9) Contract for operation of program.--
       ``(A) In general.--The Secretary may award a contract under 
     this subsection for the operation of the licensing program.
       ``(B) Term.--The duration of a contract under subparagraph 
     (A) shall not exceed 5 years and may be renewable.
       ``(C) Performance review.--The Secretary shall annually 
     review performance under a contract under subparagraph (A).
       ``(d) Providers of Interactive Computer Services or 
     Advertising Services.--No provider of interactive computer 
     services (as defined in section 230(f) of the Communications 
     Act of 1934 (47 U.S.C. 230(f)) or an advertising service 
     provider shall be liable under this section on account of 
     another person's selling or dispensing of a prescription 
     drug, so long as the provider of the interactive computer 
     service or the advertising service provider does not own or 
     exercise corporate control over such person.
       ``(e) Policies and Procedures Required To Prevent Payments 
     for Unlawful Internet Pharmacy Requests.--
       ``(1) Regulations.--Not later than 180 days after 
     designating a system under subsection (a)(2), the Board shall 
     promulgate regulations that require--
       ``(A) an operator of a credit card system that is a 
     designated payment system, an operator of an international, 
     national, or local network used to effect a credit 
     transaction, electronic fund transfer, or money transmitting 
     service that is a designated payment system, and an operator 
     of any other designated payment system specified by the Board 
     that is centrally managed and is primarily engaged in the 
     transmission and settlement of credit transactions, 
     electronic transfers, or money transmitting services where at 
     least 1 party to the transaction or transfer is an 
     individual; and
       ``(B) in the case of a designated payment system, other 
     than a designated payment system described in subparagraph 
     (A), a person described in subsection (a)(2)(B);

     to establish policies and procedures that are reasonably 
     designed to prevent the introduction of restricted 
     transactions into a designated payment system or the 
     completion of restricted transactions using a designated 
     payment system.
       ``(2) Requirements for policies and procedures.--In 
     promulgating regulations under paragraph (1), the Board 
     shall--
       ``(A) identify types of policies and procedures, including 
     nonexclusive examples, that shall be considered to be 
     reasonably designed to identify and reasonably designed to 
     prevent the introduction of a restricted transaction in a 
     designated payment or the completion of restricted 
     transactions using a designated payment system; and
       ``(B) to the extent practicable, permit any designated 
     payment system, or person described in subsection (a)(2)(B), 
     as applicable, to choose among alternative means of 
     preventing the introduction or completion of restricted 
     transactions.
       ``(3) No liability for blocking or refusing to honor 
     restricted transaction.--
       ``(A) In general.--A designated payment system, or a person 
     described in subsection (a)(2)(B), that is subject to a 
     regulation or an order issued under this subsection, and any 
     participant in such payment system, that--
       ``(i) prevents or otherwise refuses to honor restricted 
     transactions, in an effort to implement the policies and 
     procedures required

[[Page 10792]]

     under this subsection or to otherwise comply with this 
     section, shall not be liable to any party for such action; 
     and
       ``(ii) prevents or otherwise refuses to honor a 
     nonrestricted transaction in an effort to implement the 
     policies and procedures under this subsection or to otherwise 
     comply with this section, shall not be liable to any party 
     for such action.
       ``(B) Compliance with this subsection.--A person described 
     in subsection (a)(2)(B) meets the requirements of this 
     subsection, if any, if the person relies on and complies with 
     the policies and procedures of a designated payment system of 
     which the person is a member or in which the person is a 
     participant, and such policies and procedures of the 
     designated payment system comply with the requirements of the 
     regulations under paragraph (1)(B).
       ``(4) Enforcement.--
       ``(A) In general.--This subsection shall be enforced by the 
     Federal functional regulators and the Federal Trade 
     Commission under applicable law in the manner provided in 
     section 505(a) of the Gramm-Leach-Bliley Act (21 U.S.C. 
     6805(a)).
       ``(B) Factors to be considered.--In considering any 
     enforcement action under this subsection against a payment 
     system or person described in subsection (a)(2)(B), the 
     Federal functional regulators and the Federal Trade 
     Commission shall consider the following factors:
       ``(i) The extent to which the payment system or person 
     knowingly permits restricted transactions.
       ``(ii) The history of the payment system or person in 
     connection with permitting restricted transactions.
       ``(iii) The extent to which the payment system or person 
     has established and is maintaining policies and procedures in 
     compliance with regulations prescribed under this subsection.
       ``(iv) The feasibility that any specific remedy prescribed 
     can be implemented by the payment system or person without 
     substantial deviation from normal business practice.
       ``(v) The costs and burdens the specific remedy will have 
     on the payment system or person.
       ``(f) Reports Regarding Internet-Related Violations of 
     Federal and State Laws on Dispensing of Drugs.--The Secretary 
     shall, pursuant to the submission of an application meeting 
     criteria prescribed by the Secretary, make an award of a 
     grant or contract to an entity with experience in developing 
     and maintaining systems for the purpose of--
       ``(1) identifying Internet pharmacy websites that are not 
     licensed or that appear to be operating in violation of 
     Federal or State laws concerning the dispensing of drugs;
       ``(2) reporting such Internet pharmacy websites to State 
     medical licensing boards and State pharmacy licensing boards, 
     and to the Attorney General and the Secretary, for further 
     investigation; and
       ``(3) submitting, for each fiscal year for which the award 
     under this subsection is made, a report to the Secretary 
     describing investigations undertaken with respect to 
     violations described in paragraph (1).
       ``(g) Transactions Permitted.--A designated payment system 
     or person subject to a regulation or an order issued under 
     subsection (e) may engage in transactions with licensed and 
     unlicensed Internet pharmacies in connection with 
     investigating violations or potential violations of any rule 
     or requirement adopted by the payment system or person in 
     connection with complying with subsection (e). A person 
     subject to a regulation or an order issued under subsection 
     (e) and the agents and employees of that person shall not be 
     found to be in violation of, or liable under, any Federal, 
     State, or other law for engaging in any such transaction.
       ``(h) Relation to State Laws.--No requirement, prohibition, 
     or liability may be imposed on a designated payment system or 
     person subject to a regulation or an order issued under 
     subsection (e) under the laws of any State with respect to 
     any payment transaction by an individual because the payment 
     transaction involves a payment to an Internet pharmacy.
       ``(i) Timing of Requirements.--A designated payment system 
     or a person subject to a regulation under subsection (e) 
     shall adopt policies and procedures reasonably designed to 
     comply with any regulations required under subsection (e) not 
     later than 180 days after the date on which such final 
     regulations are issued.''.
       (b) Prohibited Acts.--Section 301 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding 
     at the end the following:
       ``(hh)(1) The sale, under section 511, of a drug that is 
     not a prescription drug, the sale of such a prescription drug 
     without a valid prescription from a treating provider, or the 
     ownership or operation of an Internet pharmacy, in violation 
     of section 511.
       ``(2) The representation by advertisement, sales 
     presentation, direct communication (including telephone, 
     facsimile, or electronic mail), or otherwise by an Internet 
     pharmacy, that a prescription drug may be obtained from the 
     Internet pharmacy without a prescription, in violation of 
     section 511.
       ``(3) The advertisement related to a prescription drug 
     through any media including sales presentation, direct 
     communication (including telephone, facsimile, or electronic 
     mail), by an unlicensed Internet pharmacy.
       ``(4) The provision of an untrue statement of material fact 
     in the licensing application of an Internet pharmacy.
       ``(5) For purposes of this subsection, any term used in 
     this subsection that is also used in section 511 shall have 
     the meaning given that term in section 511.''.
       (c) Links to Unlicensed Internet Pharmacies.--Section 302 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 332) 
     is amended by adding at the end the following:
       ``(c)(1) In the case of a violation of section 511 relating 
     to an unlicensed Internet pharmacy (as defined in such 
     section 511), the district courts of the United States and 
     the United States courts of the territories shall have 
     jurisdiction to order a provider of an interactive computer 
     service to remove, or disable access to, links to a website 
     violating that section that resides on a computer server that 
     the provider controls or operates.
       ``(2) Relief under paragraph (1)--
       ``(A) shall be available only after provision to the 
     provider of notice and an opportunity to appear;
       ``(B) shall not impose any obligation on the provider to 
     monitor its service or to affirmatively seek facts indicating 
     activity violating section 511;
       ``(C) shall specify the provider to which the relief 
     applies; and
       ``(D) shall specifically identify the location of the 
     website to be removed or to which access is to be 
     disabled.''.
       (d) Regulations.--
       (1) In general.--Not later than 1 year after the date of 
     enactment of this title, the Secretary of Health and Human 
     Services shall promulgate interim final regulations to carry 
     out the amendments made by this section.
       (2) Effective date.--The requirement of licensure under 
     section 511 of the Federal Food, Drug, and Cosmetic Act (as 
     added by this section) shall take effect on the date 
     determined by the Secretary of Health and Human Services but 
     in no event later than 90 days after the effective date of 
     the interim final regulations under paragraph (1).
       (e) Penalties.--Section 303 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 333) is amended by adding at the end 
     the following:
       ``(g) Notwithstanding subsection (a), any person who 
     knowingly violates paragraph (1), (2), (3), or (4) of section 
     301(hh) shall be imprisoned for not more than 10 years or 
     fined in accordance with title 18, United States Code, or 
     both.''.
                                 ______
                                 
  SA 994. Mr. GRASSLEY submitted an amendment intended to be proposed 
by him to the bill S. 1082, to amend the Federal Food, Drug, and 
Cosmetic Act to reauthorize and amend the prescription drug user fee 
provisions, and for other purposes; which was ordered to lie on the 
table; as follows:

       At the appropriate place, insert the following:

     SEC. __. CENTER FOR POSTMARKET EVALUATION AND RESEARCH FOR 
                   DRUGS AND BIOLOGICS.

       (a) In General.--Chapter V of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting 
     after section 506C the following:

     ``SEC. 507. DRUG SAFETY.

       ``(a) Establishment of the Center for Postmarket Evaluation 
     and Research for Drugs and Biologics.--There is established 
     within the Food and Drug Administration a Center for 
     Postmarket Evaluation and Research for Drugs and Biologics 
     (referred to in the section as the `Center'). The Director of 
     the Center shall report directly to the Commissioner of Food 
     and Drugs.
       ``(b) Duties of the Center for Postmarket Evaluation and 
     Research for Drugs and Biologics.--
       ``(1) Responsibilities of director.--The Director of the 
     Center, in consultation with the Director of the Center for 
     Drug Evaluation and Research or the Director of the Center 
     for Biologics Evaluation and Research, as appropriate, 
     shall--
       ``(A) conduct postmarket risk assessment of drugs approved 
     under section 505 of this Act and of biological products 
     licensed under section 351 of the Public Health Service Act;
       ``(B) conduct and improve postmarket surveillance of 
     approved drugs and licensed biological products using 
     postmarket surveillance programs and activities (including 
     MedWatch), risk-benefit analyses, adverse event reports, the 
     scientific literature, any clinical or observational studies 
     (including studies required under subsection (d) or (e)), and 
     any other resources that the Director of the Center 
     determines appropriate;
       ``(C) determine whether a study is required under 
     subsection (d) or (e) and consult with the sponsors of drugs 
     and biological products to ensure that such studies are 
     completed by the date, and according to the terms, specified 
     by the Director of the Center;
       ``(D) contract, or require the sponsor of an application or 
     the holder of an approved application or license to contract, 
     with the holders of domestic and international patient 
     databases to conduct epidemiologic and other observational 
     studies;

[[Page 10793]]

       ``(E) determine, based on postmarket surveillance programs 
     and activities (including MedWatch), risk-benefit analyses, 
     adverse event reports, the scientific literature, and any 
     clinical or observational studies (including studies required 
     under subsection (d) or (e)), and any other resources that 
     the Director of the Center determines appropriate, whether a 
     drug or biological product may present an unreasonable risk 
     to the health of patients or the general public, and take 
     corrective action if such an unreasonable risk may exist;
       ``(F) make information about the safety and effectiveness 
     of approved drugs and licensed biological products available 
     to the public and healthcare providers in a timely manner; 
     and
       ``(G) conduct other activities as the Director of the 
     Center determines appropriate to ensure the safety and 
     effectiveness of all drugs approved under section 505 and all 
     biological products licensed under section 351 of the Public 
     Health Service Act.
       ``(2) Determination of unreasonable risk.--In determining 
     whether a drug or biological product may present an 
     unreasonable risk to the health of patients or the general 
     public, the Director of the Center, in consultation with the 
     Director of the Center for Drug Evaluation and Research or 
     the Director of the Center for Biologics Evaluation and 
     Research, as appropriate, shall consider the risk in relation 
     to the known benefits of such drug or biological product.
       ``(c) Secretarial Authority.--
       ``(1) In general.--Approval of a drug under section 505 of 
     this Act or issuance of a license for a biological product 
     under section 351 of the Public Health Service Act may be 
     subject to the requirement that the sponsor conduct 1 or more 
     postmarket studies as described in subsection (d) or (e) of 
     this section, or other postmarket studies as required by the 
     Secretary, to validate the safety and effectiveness of the 
     drug or biological product.
       ``(2) Definition.--For purposes of this section, the term 
     `postmarket' means--
       ``(A) with respect to a drug, after approval of an 
     application under section 505; and
       ``(B) with respect to a biological product, after licensure 
     under section 351 of the Public Health Service Act.
       ``(d) Preapproval Review.--
       ``(1) Review of application.--
       ``(A) In general.--
       ``(i) Review.--At any time before a drug is approved under 
     section 505 of this Act or a biological product is licensed 
     under section 351 of the Public Health Service Act, the 
     Director of the Center shall review the application (or 
     supplement to the application), and any analyses associated 
     with the application, of such drug or biological product.
       ``(ii) Effect of approval or licensure.--The approval of a 
     drug under section 505 or the licensure of a biological 
     product under such section 351 shall not affect the 
     continuation and completion of a review under clause (i).
       ``(B) Limitation.--In no case shall the review under 
     subparagraph (A) delay a decision with respect to an 
     application for a drug under section 505 of this Act or for a 
     biological product under section 351 of the Public Health 
     Service Act.
       ``(2) Result of review.--The Director of the Center may, 
     based on the review under paragraph (1)--
       ``(A) require that the sponsor of the application agree to 
     conduct 1 or more postmarket studies to determine the safety 
     or effectiveness of a drug or biological product, including 
     such safety or effectiveness as compared to other drugs or 
     biological products, to be completed by a date, and according 
     to the terms, specified by the Director of the Center; or
       ``(B) contract, or require the sponsor of the application 
     to contract, with a holder of a domestic or an international 
     patient database to conduct 1 or more epidemiologic or other 
     observational studies.
       ``(e) Postmarketing Studies of Drug Safety.--
       ``(1) In general.--At any time after a drug is approved 
     under section 505 of this Act or a biological product is 
     licensed under section 351 of the Public Health Service Act, 
     the Director of the Center, may--
       ``(A) require that the holder of an approved application or 
     license conduct 1 or more studies to determine the safety or 
     effectiveness of such drug or biological product, including 
     such safety and effectiveness as compared to other drugs or 
     biological products, to be completed by a date, and according 
     to the terms, specified by such Director; or
       ``(B) contract, or require the holder of the approved 
     application or license to contract, with a holder of a 
     domestic or an international patient database to conduct 1 or 
     more epidemiologic or other observational studies.
       ``(2) Review of outstanding studies.--Not later than 90 
     days after the date of enactment of the Food and Drug 
     Administration Safety Act of 2007, the Director of the Center 
     shall--
       ``(A) review and publish a list in the Federal Register of 
     any postmarketing studies outstanding on the date of 
     enactment of the Food and Drug Administration Safety Act of 
     2007; and
       ``(B) as the Director determines appropriate, require the 
     sponsor of a study described in subparagraph (A) to conduct 
     such study under this subsection.
       ``(f) Publication of Progress Reports and Completed 
     Studies.--
       ``(1) In general.--The Director of the Center shall require 
     that the sponsor of a study under subsection (d) or (e) 
     submit to the Secretary--
       ``(A) not less frequently than every 90 days, an up-to-date 
     report describing the progress of such study; and
       ``(B) upon the completion date of such study, the results 
     of such study.
       ``(2) Completion date.--For purposes of this section, the 
     completion date of such study shall be determined by the 
     Director of the Center.
       ``(g) Determinations by Director.--
       ``(1) Results of study.--The Director of the Center shall 
     determine, upon receipt of the results of a study required 
     under subsection (d) or (e)--
       ``(A) whether the drug or biological product studied may 
     present an unreasonable risk to the health of patients or the 
     general public; and
       ``(B) what, if any, corrective action under subsection (k) 
     shall be taken to protect patients and the public health.
       ``(2) Results of evidence.--The Director of the Center may, 
     at any time, based on the empirical evidence from postmarket 
     surveillance programs and activities (including MedWatch), 
     risk-benefit analyses, adverse event reports, the scientific 
     literature, any clinical or observational studies (including 
     studies required under subsection (d) or (e)), or any other 
     resources that the Director of the Center determines 
     appropriate--
       ``(A) make a determination that a drug or biological 
     product may present an unreasonable risk to the health of 
     patients or the general public; and
       ``(B) order a corrective action under subsection (k) be 
     taken to protect patients and the public health.
       ``(3) Required consultation and considerations.--Before 
     making a determination under paragraph (2), ordering a study 
     under subsection (d) or (e), or taking a corrective action 
     under subsection (k), the Director of the Center shall--
       ``(A) consult with the Director of the Center for Drug 
     Evaluation and Research or the Director of the Center for 
     Biologics Evaluation and Research, as appropriate; and
       ``(B) consider--
       ``(i) the benefit-to-risk profile of the drug or biological 
     product;
       ``(ii) the effect that a corrective action, or failure to 
     take corrective action, will have on the patient population 
     that relies on the drug or biological product; and
       ``(iii) the extent to which the drug or biological product 
     presents a meaningful therapeutic benefit as compared to 
     other available treatments.
       ``(h) Public Information.--Periodically, but not less often 
     than every 90 days, the Secretary shall make available to the 
     public, by publication in the Federal Register and posting on 
     an Internet website, the following information:
       ``(1) Studies required under subsection (d) or (e) 
     including--
       ``(A) the type of study;
       ``(B) the nature of the study;
       ``(C) the primary and secondary outcomes of the study;
       ``(D) the date the study was required under subsection (d) 
     or (e) or was agreed to by the sponsor;
       ``(E) the deadline for completion of the study; and
       ``(F) if the study has not been completed by the deadline 
     under subparagraph (E), a statement that explains why.
       ``(2) The periodic progress reports and results of 
     completed studies described under subsection (f).
       ``(3) Any determinations made by the Director of the Center 
     under subsection (g), including--
       ``(A) reasons for the determination, including factual 
     basis for such determination;
       ``(B) reference to supporting empirical data; and
       ``(C) an explanation that describes why contrary data is 
     insufficient.
       ``(i) Drug Advisory Committee.--The Drug Safety and Risk 
     Management Advisory Committee within the Center of the Food 
     and Drug Administration shall--
       ``(1) meet not less frequently than every 180 days; and
       ``(2) make recommendations to the Director of the Center 
     with respect to--
       ``(A) which drugs and biological products should be the 
     subject of a study under subsection (d) or (e);
       ``(B) the design and duration for studies under subsection 
     (d) or (e);
       ``(C) which drugs and biological products may present an 
     unreasonable risk to the health of patients or the general 
     public; and
       ``(D) appropriate corrective actions under subsection (k).
       ``(j) Penalties.--
       ``(1) In general.--If the Secretary determines, after 
     notice and opportunity for an informal hearing, that a 
     sponsor of a drug or biological product or other entity has 
     failed to complete a study required under subsection (d) or 
     (e) by the date or to the terms

[[Page 10794]]

     specified by the Secretary under such subsection, the 
     Secretary may order such sponsor or other entity to--
       ``(A) complete the study in a specified time;
       ``(B) revise the study to comply with the terms specified 
     by the Secretary under subsection (d) or (e); or
       ``(C) pay a civil penalty.
       ``(2) Amount of penalties.--
       ``(A) In general.--The civil penalty ordered under 
     paragraph (1) shall be $250,000 for the first 30-day period 
     after the date specified by the Secretary that the study is 
     not completed, and shall double in amount for every 30-day 
     period thereafter that the study is not completed.
       ``(B) Limitation.--In no case shall a penalty under 
     subparagraph (A) exceed $2,000,000 for any 30-day period.
       ``(3) Notification of penalty.--The Secretary shall publish 
     in the Federal Register any civil penalty ordered under this 
     subsection.
       ``(k) Result of Determination.--
       ``(1) In general.--If the Director of the Center makes a 
     determination that a drug or biological product may present 
     an unreasonable risk to the health of patients or the general 
     public under subsection (g), such Director shall order a 
     corrective action, as described under paragraph (2).
       ``(2) Corrective actions.--The corrective action described 
     under subsection (g)--
       ``(A) may include--
       ``(i) requiring a change to the drug or biological product 
     label by a date specified by the Director of the Center;
       ``(ii) modifying the approved indication of the drug or 
     biological product to restrict use to certain patients;
       ``(iii) placing restriction on the distribution of the drug 
     or biological product to ensure safe use;
       ``(iv) requiring the sponsor of the drug or biological 
     product or license to establish a patient registry;
       ``(v) requiring patients to sign a consent form prior to 
     receiving a prescription of the drug or biological product;
       ``(vi) requiring the sponsor to monitor sales and usage of 
     the drug or biological product to detect unsafe use;
       ``(vii) requiring patient or physician education; and
       ``(viii) requiring the establishment of a risk management 
     plan by the sponsor; and
       ``(B) shall include the requirements with respect to 
     promotional material under subsection (l)(1).
       ``(3) Penalties.--
       ``(A) In general.--If the Secretary determines, after 
     notice and opportunity for an informal hearing, that a 
     sponsor of a drug or biological product has failed to take 
     the corrective action ordered by the Director of the Center 
     under this subsection or has failed to comply with subsection 
     (l)(2), the Secretary may order such sponsor to pay a civil 
     penalty.
       ``(B) Amount of penalties.--
       ``(i) In general.--The civil penalty ordered under 
     subparagraph (A) shall be $250,000 for the first 30-day 
     period that the sponsor does not comply with the order under 
     paragraph (1), and shall double in amount for every 30-day 
     period thereafter that the order is not complied with.
       ``(ii) Limitation.--In no case shall a penalty under clause 
     (i) exceed $2,000,000 for any 30-day period.
       ``(C) Notification of penalty.--The Secretary shall publish 
     in the Federal Register any civil penalty ordered under this 
     paragraph.
       ``(l) Promotion Material.--
       ``(1) Safety issue.--If the Director of the Center makes a 
     determination that a drug or biological product may present 
     an unreasonable risk to the health of patients or the general 
     public under subsection (g), such Director, in consultation 
     with the Division of Drug Marketing, Advertising, and 
     Communications of the Food and Drug Administration, shall--
       ``(A) notwithstanding section 502(n), require that the 
     sponsor of such drug or biological product submit to the 
     Director of the Center copies of all promotional material 
     with respect to the drug or biological product not less than 
     30 days prior to the dissemination of such material; and
       ``(B) require that all promotional material with respect to 
     the drug or biological product include certain disclosures, 
     which shall be displayed prominently and in a manner easily 
     understood by the general public, including--
       ``(i) a statement that describes the unreasonable risk to 
     the health of patients or the general public as determined by 
     the Director of the Center;
       ``(ii) a statement that encourages patients to discuss 
     potential risks and benefits with their healthcare provider;
       ``(iii) a description of the corrective actions required 
     under subsection (k);
       ``(iv) where appropriate, a statement explaining that there 
     may be products available to treat the same disease or 
     condition that present a more favorable benefit-to-risk 
     profile, and that patients should talk to their healthcare 
     provider about the risks and benefits of alternative 
     treatments;
       ``(v) a description of any requirements of outstanding 
     clinical and observational studies, including the purpose of 
     each study; and
       ``(vi) contact information to report a suspected adverse 
     reaction.
       ``(2) New products; outstanding studies.--For the first 2-
     year period after a drug is approved under section 505 of 
     this Act or a biological product is licensed under section 
     351 of the Public Health Service Act, and with respect to 
     drugs and biological products for which there are outstanding 
     study requirements under subsection (d) or (e), the Director 
     of the Center, in consultation with the Division of Drug 
     Marketing, Advertising, and Communications of the Food and 
     Drug Administration, shall--
       ``(A) notwithstanding section 502(n), require that the 
     sponsor of such drug or biological product submit to the 
     Director of the Center copies of all promotional material 
     with respect to the drug or biological product not less than 
     30 days prior to the dissemination of such material; and
       ``(B) require that all promotional material with respect to 
     the drug or biological product include certain disclosures, 
     which shall be displayed prominently and in a manner easily 
     understood by the general public, including--
       ``(i) a statement explaining that the drug or biological 
     product is newly approved or licensed or the subject of 
     outstanding clinical or observational studies, as the case 
     may be, and, as a result, not all side effects or drug 
     interactions may be known;
       ``(ii) the number of people in which the drug or biological 
     product has been studied and the duration of time during 
     which the drug or biological product has been studied;
       ``(iii) a statement that encourages patients to discuss the 
     potential risks and benefits of treatment with their 
     healthcare provider;
       ``(iv) a description of any requirements of outstanding 
     clinical and observational studies, including the purpose of 
     each study; and
       ``(v) contact information to report a suspected adverse 
     reaction.
       ``(3) Effect of voluntary submission.--Paragraphs (1)(A) 
     and (2)(A) shall not apply to the sponsor of a drug or 
     biological product if such sponsor has voluntarily submitted 
     to the Division of Drug Marketing, Advertising, and 
     Communications of the Food and Drug Administration all 
     promotional material with respect to the drug or biological 
     product prior to the dissemination of such material.
       ``(m) Withdrawal or Suspension of Approval or Licensure.--
       ``(1) In general.--The Director of the Center, may withdraw 
     or suspend approval of a drug or licensure of a biological 
     product using expedited procedures (as prescribed by the 
     Secretary in regulations promulgated not later than 1 year 
     after the date of enactment of the Food and Drug 
     Administration Safety Act of 2007, which shall include an 
     opportunity for an informal hearing) after consultation with 
     the Director of the Center for Drug Evaluation and Research 
     or the Director of the Center for Biologics Evaluation and 
     Research, as appropriate, and any other person as determined 
     appropriate by the Director of the Center, if--
       ``(A) the Director of the Center makes a determination that 
     the drug or biological product may present an unreasonable 
     risk to the health of patients or the general public, and 
     that risk cannot be satisfactorily alleviated by a corrective 
     action under subsection (k); or
       ``(B) the sponsor fails to comply with an order or 
     requirement under this section.
       ``(2) Public information.--The Secretary shall make 
     available to the public, by publication in the Federal 
     Register and posting on an Internet website, the details of 
     the consultation described in paragraph (1), including--
       ``(A) the reason for the determination to withdraw, 
     suspend, or failure to withdraw or suspend, approval for the 
     drug or licensure for the biological product;
       ``(B) the factual basis for such determination;
       ``(C) reference to supporting empirical data;
       ``(D) an explanation that describes why contrary data is 
     insufficient; and
       ``(E) the position taken by each individual consulted.
       ``(n) Effect of Section.--The authorities conferred by this 
     section shall be separate from and in addition to the 
     authorities conferred by section 505B.
       ``(o) Administration of Section.--The provisions of this 
     section shall be carried out by the Secretary, acting through 
     the Director of the Center.''.
       (b) Misbranding.--Section 502 of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 352) is amended by inserting 
     after subsection (j) the following:
       ``(k) If it is a drug or biological product for which the 
     sponsor of an application or holder of an approved 
     application or license has not complied with an order or 
     requirement under section 507.''.
       (c) Report on Devices.--Not later than 6 months after the 
     date of enactment of this Act, the Secretary of Health and 
     Human Services, in consultation with the Commissioner of Food 
     and Drugs, the Director of the Center for Postmarket 
     Evaluation and Research for Drugs and Biologics, and the 
     Director of the Center for Devices and Radiological Health, 
     shall submit to Congress a report that--
       (1) identifies gaps in the current process of postmarket 
     surveillance of devices approved

[[Page 10795]]

     under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 
     et seq.);
       (2) includes recommendations on ways to improve gaps in 
     postmarket surveillance of devices; and
       (3) identifies the changes in authority needed to make 
     those improvements, recognizing the legitimate differences 
     between devices and other medical products regulated by the 
     Food and Drug Administration.
       (d) Transfer of Functions.--The functions and duties of the 
     Office of Surveillance and Epidemiology, including the Drug 
     Safety and Risk Management Advisory Committee, of the Food 
     and Drug Administration on the day before the date of 
     enactment of this Act shall be transferred to the Center for 
     Postmarket Evaluation and Research for Drugs and Biologics 
     established under section 507 of the Federal Food, Drug, and 
     Cosmetic Act (as added by this section). The Center for 
     Postmarket Evaluation and Research for Drugs and Biologics 
     shall be a separate entity within the Food and Drug 
     Administration and shall not be an administrative office of 
     the Center for Drug Evaluation and Research or the Center for 
     Biologics Evaluation and Research.
       (e) Authorization of Appropriations.--There are authorized 
     to be appropriated to carry out this section (and the 
     amendments made by this section)--
       (1) $50,000,000 for fiscal year 2008;
       (2) $75,000,000 for fiscal year 2009;
       (3) $100,000,000 for fiscal year 2010;
       (4) $125,000,000 for fiscal year 2011; and
       (5) $150,000,000 for fiscal year 2012.
                                 ______
                                 
  SA 995. Mr. GRASSLEY submitted an amendment intended to be proposed 
by him to the bill S. 1082, to amend the Federal Food, Drug, and 
Cosmetic Act to reauthorize and amend the prescription drug user fee 
provisions, and for other purposes; which was ordered to lie on the 
table; as follows:

       At the end of subtitle E of title II, insert the following:

     SEC. 2_. AUTHORITY OF THE OFFICE OF SURVEILLANCE AND 
                   EPIDEMIOLOGY; CHIEF SAFETY OFFICER.

       (a) Authority.--With respect to all actions of the Food and 
     Drug Administration related to postmarketing drug safety, 
     including labeling changes, postapproval studies, and 
     restrictions on distribution or use of drugs with serious 
     risks, the Office of Surveillance and Epidemiology (or 
     successor office) of such Administration and the Office of 
     New Drugs (or successor office) of such Administration shall 
     make decisions jointly. In the event of a disagreement with 
     respect to an action related to postmarketing drug safety, 
     including labeling changes, postapproval studies, and 
     restrictions on distribution or use of drugs with serious 
     risks, between such 2 offices, the Commissioner of Food and 
     Drugs shall make the decision with respect to such action.
       (b) Chief Safety Officer.--Notwithstanding any other 
     provision of law, the Director of the Office of Surveillance 
     and Epidemiology (or successor office) of the Food and Drug 
     Administration shall serve as the Chief Postmarket Drug 
     Safety Officer within the Food and Drug Administration. In 
     such capacity, the Director shall serve as a liaison between 
     the Office of the Commissioner of Food and Drugs and 
     employees of the Food and Drug Administration. To ensure drug 
     safety concerns are identified and promptly evaluated and 
     resolved, any employee of the Center for Drug Evaluation and 
     Research within the Food and Drug Administration who has drug 
     safety concerns may report such concerns to the Chief 
     Postmarket Drug Safety Officer.
                                 ______
                                 
  SA 996. Mr. GRASSLEY submitted an amendment intended to be proposed 
by him to the bill S. 1082, to amend the Federal Food, Drug, and 
Cosmetic Act to reauthorize and amend the prescription drug user fee 
provisions, and for other purposes; which was ordered to lie on the 
table; as follows:

       At the end of section 505 of the Federal Food, Drug, and 
     Cosmetic Act, as amended by section 251 of the bill, add the 
     following:
       ``(r) Certification of Information.--When submitting 
     information in support of a new drug application or a 
     supplemental new drug application, the sponsor shall certify, 
     in writing, that all clinical trials, federally or privately 
     funded, whether conducted within or outside the United 
     States, related to the safety or efficacy of the drug under 
     review, have been submitted to the Food and Drug 
     Administration.''.
                                 ______
                                 
  SA 997. Mr. GRASSLEY submitted an amendment intended to be proposed 
by him to the bill S. 1082, to amend the Federal Food, Drug, and 
Cosmetic Act to reauthorize and amend the prescription drug user fee 
provisions, and for other purposes; which was ordered to lie on the 
table; as follows:

       Strike clause (i) of section 402(j)(3)(A) of the Public 
     Health Service Act, as added by this bill, and insert the 
     following:
       ``(i) In general.--

       ``(I) Requirement.--Not later than 90 days after the date 
     of enactment of the Food and Drug Administration 
     Revitalization Act, for all clinical trials (except as 
     provided in subclause (II)), whether federally or privately 
     funded, conducted to test the safety or efficacy (including 
     comparative efficacy), of any drug or device (including those 
     drugs or devices approved or cleared by the Secretary), the 
     Secretary shall ensure that the registry data bank includes 
     links to results information for such clinical trial--

       ``(aa) not earlier than 30 days after the date of the 
     approval of the drug involved or clearance or approval of the 
     device involved; or
       ``(bb) not later than 30 days after such information 
     becomes publicly available, as applicable.

       ``(II) Exception.--The requirement of subclause (I) shall 
     not apply to phase I clinical investigations conducted to 
     test solely the safety of an unapproved drug or unlicensed 
     biological product, or pilot or feasibility studies conducted 
     to confirm the design and operating specifications of an 
     unapproved or not yet cleared medical device.
       ``(III) Voluntary submission.--A responsible party for a 
     clinical trial that is not an applicable drug clinical trial 
     or an applicable device clinical trial may submit to the 
     Secretary results information for a clinical trial described 
     in subclause (II).

       At the end section 402(j)(4) of the Public Health Service 
     Act, as added by this bill, insert the following:
       ``(F) Trials conducted outside of the united states.--
       ``(i) In general.--With respect to clinical trials 
     described in clause (ii), the responsible party shall submit 
     to the Secretary the information required under this 
     subsection. The Secretary shall ensure that such information 
     and the results of such clinical trials are made available to 
     the public in a timely manner and as soon as practicable 
     after receiving such information. Failure to comply with this 
     paragraph shall be deemed to be a failure to submit 
     information as required under this subsection, and the 
     appropriate remedies and sanctions under this section shall 
     apply.
       ``(ii) Clinical trial described.--A clinical trial is 
     described in this clause if--

       ``(I) such trial is conducted outside of the United States; 
     and
       ``(II) the data from such trial is--

       ``(aa) submitted to the Secretary as part of an 
     application, including a supplemental application, for a drug 
     or device under section 505, 510, 515, or 520 of the Federal 
     Food, Drug, and Cosmetic Act or for the biological product 
     under section 351 of this Act; or
       ``(bb) used in advertising or labeling to make a claim 
     about the drug or device involved.
                                 ______
                                 
  SA 998. Mr. GRASSLEY submitted an amendment intended to be proposed 
by him to the bill S. 1082, to amend the Federal Food, Drug, and 
Cosmetic Act to reauthorize and amend the prescription drug user fee 
provisions, and for other purposes; which was ordered to lie on the 
table; as follows:

       At the appropriate place in section 505(o) of the Federal, 
     Food, Drug, and Cosmetic, as added by section 202, insert the 
     following:
       ``(9) Civil monetary penalty.--Notwithstanding any other 
     provision of this Act, an applicant (as such term is defined 
     for purposes of this section) that knowingly fails to comply 
     with a requirement of an approved risk evaluation and 
     mitigation strategy under this subsection shall be subject to 
     a civil money penalty of $250,000 for the first 30-day period 
     that the applicant is in noncompliance, and such amount shall 
     double for every 30-day period thereafter that the 
     requirement is not complied with, not to exceed 
     $2,000,000.''.
                                 ______
                                 
  SA 999. Mr. GRASSLEY submitted an amendment intended to be proposed 
by him to the bill S. 1082, to amend the Federal Food, Drug, and 
Cosmetic Act to reauthorize and amend the prescription drug user fee 
provisions, and for other purposes; which was ordered to lie on the 
table; as follows:

       At the end of section 505 of the Federal Food, Drug, and 
     Cosmetic Act, as amended by section 251 of the bill, add the 
     following:
       ``(r) Certification of Information.--
       ``(1) Certification.--
       ``(A) Requirement.--When submitting information in support 
     of a new drug application or a supplemental new drug 
     application, the sponsor shall certify, in writing, that the 
     information submitted to the Food and Drug Administration 
     complies with the requirements of this Act and that such 
     information is not false or misleading.
       ``(B) Failure to submit.--If the sponsor fails to provide a 
     certification as required under subparagraph (A), the 
     Secretary shall transmit to such sponsor a notice stating 
     that such sponsor shall submit the certification by a date 
     determined by the Secretary. If, by the date specified by the 
     Secretary in the notice under this subparagraph, the 
     Secretary has not received the certification, the Secretary, 
     after providing the opportunity for a hearing, shall order 
     such sponsor to pay a civil monetary penalty of

[[Page 10796]]

     $10,000 for each day after such date that such certification 
     is not submitted.
       ``(C) Additional civil monetary penalty.--If the Secretary 
     determines, after notice and opportunity for a hearing, that 
     a sponsor knew or should have known that the information 
     submitted in support of a new drug application or a 
     supplemental new drug application was false or inaccurate, 
     the Secretary shall order such sponsor to pay a civil 
     monetary penalty of not less than $100,000, but not to exceed 
     $2,000,000.
       ``(2) Required statement.--The certification under 
     paragraph (1) shall include a statement that all clinical 
     trials, federally or privately funded, whether conducted 
     within or outside the United States, related to the safety or 
     efficacy of the drug under review, have been submitted to the 
     Food and Drug Administration.
       ``(3) Clinical comparison studies.--
       ``(A) In general.--The Secretary shall deposit funds 
     collected under paragraph (1) into an account and use such 
     funds shall be used, after consultation with the Director of 
     the Agency for Healthcare Research and Quality, to fund 
     studies that compare the clinical effectiveness of 2 or more 
     treatments for similar diseases or conditions.
       ``(B) Priority list.--The Secretary shall award funding 
     under subparagraph (A) based on a priority list established, 
     not later than 6 months after the date of enactment of this 
     Act, by the Director of the Agency for Healthcare Research 
     and Quality and periodically updated as determined 
     appropriate by the Director.
       ``(4) Drug consultations.--Not later than 90 days after the 
     date of the completion of a written consultation on a drug 
     concerning the drug's safety, as conducted by the Office of 
     Surveillance and Epidemiology, regardless of whether such 
     consultation was initiated by such Office or by an entity 
     outside of the Office, the Commissioner of Food and Drugs 
     shall make available to the public a full copy of such 
     consultation.
       ``(5) Rule of construction.--Nothing in this subsection 
     shall be construed to alter or amend section 301(j) of this 
     Act or section 1905 of title 18, United States Code.''.
                                 ______
                                 
  SA 1000. Mr. GRASSLEY submitted an amendment intended to be proposed 
by him to the bill S. 1082, to amend the Federal Food, Drug, and 
Cosmetic Act to reauthorize and amend the prescription drug user fee 
provisions, and for other purposes; which was ordered to lie on the 
table; as follows:

       At the appropriate place, insert the following:

                    TITLE__FDA EMPLOYEE PROTECTIONS

     SEC. __01. SHORT TITLE.

       This title may be cited as the ``FDA Employee Rights 
     Protection Act''.

     SEC. __02. EMPLOYEES' RIGHT TO PETITION CONGRESS.

       The right of all employees of the Food and Drug 
     Administration, individually or collectively, to petition 
     Congress or a Member of Congress, or to furnish information 
     to either House of Congress, or to a committee or Member 
     thereof, shall not be interfered with or denied by any 
     employee of the Food and Drug Administration, the Department 
     of Health and Human Services, the Department of Justice, or 
     any other employee of the Executive Branch of the Federal 
     Government.

     SEC. _03. PENALTIES.

       Any individual who intentionally or willfully obstructs, 
     impedes, or otherwise interferes with an employee's right to 
     furnish information as described in section __02 shall be 
     subject to a fine of not less than $10,000 per violation, or 
     imprisoned for not more than 1 year, or both.
                                 ______
                                 
  SA 1001. Mr. GRASSLEY submitted an amendment intended to be proposed 
by him to the bill S. 1082, to amend the Federal Food, Drug, and 
Cosmetic Act to reauthorize and amend the prescription drug user fee 
provisions, and for other purposes; which was ordered to lie on the 
table; as follows:

       At the appropriate place, insert the following:

     SEC. __. SUBPOENA AUTHORITY OF THE COMMISSIONER OF FOOD AND 
                   DRUGS.

       (a) In General.--Section 310 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 337) is amended by adding at the end 
     the following:
       ``(c) For the purpose of--
       ``(1) any hearing, investigation, or other proceeding 
     respecting a violation of this Act,
       ``(2) any hearing, investigation, or other proceeding to 
     determine if a person is in compliance with a standard or 
     other requirement under this Act, or
       ``(3) any hearing, investigation, or other proceeding to 
     establish a standard or other requirement under this Act,
     the Commissioner may issue subpoenas requiring the attendance 
     and testimony of witnesses and the production of documentary 
     evidence. Such attendance of witnesses and production of 
     evidence at the designated place of such hearing, 
     investigation, or other proceeding may be required from any 
     place in the United States or in any territory or possession 
     of the United States. Subpoenas of the Commissioner shall be 
     served by a person authorized by the Commissioner by 
     delivering a copy thereof to the person named therein or by 
     certified mail addressed to such person at such person's last 
     known dwelling place or principal place of business. A 
     verified return by the person so serving the subpoena setting 
     forth the manner of service, or, in the case of service by 
     certified mail, the return post office receipt therefor 
     signed by the person so served, shall be proof of service. 
     Witnesses so subpoenaed shall be paid the same fees and 
     mileage as are paid witnesses in the district courts of the 
     United States.
       ``(d) In case of a refusal to obey a subpoena duly served 
     upon any person under subsection (c), any district court of 
     the United States for the judicial district in which such 
     person charged with refusal to obey is found, resides, or 
     transacts business, upon application by the Commissioner, 
     shall have jurisdiction to issue an order requiring such 
     person to appear and give testimony or to appear and produce 
     evidence, or both. The failure to obey such order of the 
     court may be punished by the court as contempt thereof.''.
       (b) Enforcement.--Section 301 (21 U.S.C. 331) is amended by 
     adding at the end the following:
       ``(jj) The failure or refusal to obey a subpoena issued by 
     the Commissioner under section 310(c).''.
                                 ______
                                 
  SA 1002. Mr. GRASSLEY submitted an amendment intended to be proposed 
by him to the bill S. 1082, to amend the Federal Food, Drug, and 
Cosmetic Act to reauthorize and amend the prescription drug user fee 
provisions, and for other purposes; which was ordered to lie on the 
table; as follows:

       At the appropriate place, insert the following:

     SEC. __. REQUIREMENT TO DOCUMENT CONTACT WITH DRUG SPONSORS.

       Section 505 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 355), as amended by section 251, is further amended by 
     adding at the end the following:
       ``(r) Requirement to Document Contact With Drug Sponsor.--
     Each employee of the Food and Drug Administration shall 
     document, in writing, each communication or contact, and the 
     purpose of such communication or contact, that such official 
     has with a sponsor of a drug for which an application is 
     filled pursuant to subsection (b) or (j).''.
                                 ______
                                 
  SA 1003. Mr. GRASSLEY submitted an amendment intended to be proposed 
by him to the bill S. 1082, to amend the Federal Food, Drug, and 
Cosmetic Act to reauthorize and amend the prescription drug user fee 
provisions, and for other purposes; which was ordered to lie on the 
table; as follows:

       After section 211 of the bill, insert the following:

     SEC. 211A. REQUIREMENT TO SUBMIT INFORMATION ELECTRONICALLY.

       Subchapter E of chapter V of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 360bbb et seq.), as amended by this 
     Act, is further amended by adding at the end the following:

     ``SEC. 567. REQUIREMENT TO SUBMIT INFORMATION ELECTRONICALLY.

       ``Not later than 5 years after the date of enactment of the 
     Food and Drug Administration Revitalization Act, the 
     Secretary shall ensure that any information required to be 
     submitted to the Food and Drug Administration under section 
     505, 505A, 505B, 506A, 506B, 510, 512, 513, 515, 519, 520, or 
     526 is submitted in electronic form that is interoperable 
     with the Food and Drug Administration's information 
     technology systems.''.
                                 ______
                                 
  SA 1004. Ms. LANDRIEU proposed an amendment to the bill S. 1082, to 
amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend 
the prescription drug user fee provisions, and for other purposes; as 
follows:

       At the end of the bill, add the following:

                TITLE__DOMESTIC PET TURTLE MARKET ACCESS

     SEC. __. SHORT TITLE.

       This title may be cited as the ``Domestic Pet Turtle Market 
     Access Act of 2007''.

     SEC. __. FINDINGS.

       Congress makes the following findings:
       (1) Pet turtles less than 10.2 centimeters in diameter have 
     been banned for sale in the United States by the Food and 
     Drug Administration since 1975 due to health concerns.
       (2) The Food and Drug Administration does not ban the sale 
     of iguanas or other lizards, snakes, frogs, or other 
     amphibians or reptiles that are sold as pets in the United 
     States that also carry salmonella bacteria. The Food and Drug 
     Administration also does not require that these animals be 
     treated for salmonella bacteria before being sold as pets.
       (3) The technology to treat turtles for salmonella, and 
     make them safe for sale, has greatly advanced since 1975. 
     Treatments exist that can nearly eradicate salmonella from 
     turtles, and individuals are more aware of the causes of 
     salmonella, how to treat salmonella poisoning, and the 
     seriousness associated with salmonella poisoning.

[[Page 10797]]

       (4) University research has shown that these turtles can be 
     treated in such a way that they can be raised, shipped, and 
     distributed without having a recolonization of salmonella.
       (5) University research has also shown that pet owners can 
     be equipped with a treatment regiment that allows the turtle 
     to be maintained safe from salmonella.
       (6) The Food and Drug Administration should allow the sale 
     of turtles less than 10.2 centimeters in diameter as pets as 
     long as the sellers are required to use proven methods to 
     treat these turtles for salmonella.

     SEC. __. SALE OF BABY TURTLES.

       (a) Notwithstanding any other provision of law, the Food 
     and Drug Administration shall not restrict the sale by a 
     turtle farmer, wholesaler or commercial retail seller of a 
     turtle that is less than 10.2 centimeters in diameter as a 
     pet if--
       (1) the State or territory in which such farmer is located 
     has developed a regulatory process by which pet turtle 
     farmers are required to have a State license to breed, hatch, 
     propagate, raise, grow, receive, ship, transport, export, or 
     sell pet turtles or pet turtle eggs;
       (2) such State or territory requires certification of 
     sanitization that is signed by a veterinarian who is licensed 
     in the State or territory, and approved by the State or 
     territory agency in charge of regulating the sale of pet 
     turtles;
       (3) the certification of sanitization requires each turtle 
     to be sanitized or treated for diseases, including 
     salmonella, and is dependant upon using the Siebeling method, 
     or other such proven method, which uses an antibiotic to make 
     the turtle salmonella-free; and
       (4) the turtle farmer or commercial retail seller includes, 
     with the sale of such a turtle, a disclosure to the buyer 
     that includes--
       (A) information regarding--
       (i) the possibility that salmonella can re-colonize in 
     turtles;
       (ii) the dangers, including possible severe illness or 
     death, especially for at-risk people who may be susceptible 
     to salmonella poisoning, such as children, pregnant women, 
     and others who may have weak immune systems, that could 
     result if the turtle is not properly handled and safely 
     maintained;
       (iii) the proper handling of the turtle, including an 
     explanation of proper hygiene such as handwashing after 
     handling a turtle; and
       (iv) the proven methods of treatment that, if properly 
     applied, keep the turtle safe from salmonella;
       (B) a detailed explanation of how to properly treat the 
     turtle to keep it safe from salmonella, using the proven 
     methods of treatment referred to under subparagraph (A), and 
     how the buyer can continue to purchase the tools, treatments, 
     or any other required item to continually treat the turtle; 
     and
       (C) a statement that buyers of pet turtles should not 
     abandon the turtle or abandon it outside, as the turtle may 
     become an invasive species to the local community, but should 
     instead return them to a commercial retail pet seller or 
     other organization that would accept turtles no longer wanted 
     as pets.
       (b) FDA Review of State Protections.--The Food and Drug 
     Administration may, after providing an opportunity for the 
     affected State to respond, restrict the sale of a turtle only 
     if the Secretary of Health and Human Services determines that 
     the actual implementation of State health protections 
     described in subsection (a) are insufficient to protect 
     consumers against infectious diseases acquired from such 
     turtles at the time of sale.
                                 ______
                                 
  SA 1005. Mr. LEVIN submitted an amendment intended to be proposed by 
him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic 
Act to reauthorize and amend the prescription drug user fee provisions, 
and for other purposes; which was ordered to lie on the table; as 
follows:

       At the appropriate place, insert the following:

     SEC. __. SAFETY OF FOOD ADDITIVES.

       Not later than 90 days after the date of enactment of this 
     Act, the Food and Drug Administration shall issue a report on 
     the question of whether substances used in fresh meat that 
     are capable of artificially keeping such meat red beyond the 
     point of spoilage of such meat, create a health risk or are 
     misleading to consumers.
                                 ______
                                 
  SA 1006. Ms. MURKOWSKI submitted an amendment intended to be proposed 
by her to the bill S. 1082, to amend the Federal Food, Drug, and 
Cosmetic Act to reauthorize and amend the prescription drug user fee 
provisions, and for other purposes; which was ordered to lie on the 
table; as follows:

       At the end of section 505(o)(6) of the Federal Food, Drug, 
     and Cosmetic Act, as added by section 202 of the bill, insert 
     the following:
       ``(H) In a case where a drug may be prescribed only by a 
     physician with particular training or experience, or who is 
     specially certified, a health care provider who is not so 
     certified or trained to prescribe the drug may enter into a 
     cooperation plan with a physician who has particular training 
     or experience, or is specially certified, in order to 
     prescribe such drug with the informed consent of the patient. 
     The Commissioner of Food and Drugs shall determine the 
     requirements for such cooperation plan.
                                 ______
                                 
  SA 1007. Mr. REID (for Mr. Bunning) proposed an amendment to the 
resolution S. Res. 162, commemorating and acknowledging the dedication 
and sacrifice made by the men and women who have lost their lives while 
serving as law enforcement officers; as follows:

       On page 2, strike the first whereas clause and insert:
       Whereas peace officers are on the front lines in protecting 
     the schools and schoolchildren of the United States;

                          ____________________