[Congressional Record (Bound Edition), Volume 153 (2007), Part 8]
[Senate]
[Pages 11392-11400]
[From the U.S. Government Publishing Office, www.gpo.gov]




                           TEXT OF AMENDMENTS

  SA 1045. Mr. REID (for Mr. Obama) submitted an amendment intended to 
be proposed by Mr. Reid 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. __. IMPROVING GENETIC TEST SAFETY AND QUALITY.

       Not later than 30 days after the date of enactment of this 
     Act, the Secretary shall enter into a contract with the 
     Institute of Medicine to conduct a study to assess the 
     overall safety and quality of genetic tests and prepare a 
     report that includes recommendations to improve Federal 
     oversight and regulation of genetic tests. Such study shall 
     take into consideration relevant reports by the Secretary's 
     Advisory Committee on Genetic Testing and other groups and 
     shall be completed not later than 1 year after the date on 
     which the Secretary entered into such contract.

                                 ______
                                 
  SA 1046. Ms. STABENOW (for herself, Mr. Kohl, Mr. Hatch, and Mr. 
Coburn) 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 appropriate place, insert the following:

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

       Section 505 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 355), as amended by this Act, is amended by adding at 
     the end the following:
       ``(s) Citizen Petitions and Petitions for Stay of Agency 
     Action.--
       ``(1) In general.--
       ``(A) No delay of consideration or approval.--
       ``(i) In general.--With respect to a pending application 
     submitted under subsection (b)(2) or (j), if a petition is 
     submitted to the Secretary that seeks to have the Secretary 
     take, or refrain from taking, any form of action relating to 
     the approval of the application, including a delay in the 
     effective date of the application, clauses (ii) and (iii) 
     shall apply.
       ``(ii) No delay of consideration or approval.--Except as 
     provided in clause (iii), the receipt and consideration of a 
     petition described in clause (i) shall not delay 
     consideration or approval of an application submitted under 
     subsection (b)(2) or (j).
       ``(iii) No delay of approval without determination.--The 
     Secretary shall not delay

[[Page 11393]]

     approval of an application submitted under subsection (b)(2) 
     or (j) while a petition described in clause (i) is reviewed 
     and considered unless the Secretary determines, not later 
     than 25 business days after the submission of the petition, 
     that a delay is necessary to protect the public health.
       ``(B) Determination of delay.--With respect to a 
     determination by the Secretary under subparagraph (A)(iii) 
     that a delay is necessary to protect the public health the 
     following shall apply:
       ``(i) Not later than 5 days after making such 
     determination, the Secretary shall publish on the Internet 
     website of the Food and Drug Administration a detailed 
     statement providing the reasons underlying the determination. 
     The detailed statement shall include a summary of the 
     petition and comments and supplements, the specific 
     substantive issues that the petition raises which need to be 
     considered prior to approving a pending application submitted 
     under subsection (b)(2) or (j), and any clarifications and 
     additional data that is needed by the Secretary to promptly 
     review the petition.
       ``(ii) Not later than 10 days after making such 
     determination, the Secretary shall provide notice to the 
     sponsor of the pending application submitted under subsection 
     (b)(2) or (j) and provide an opportunity for a meeting with 
     appropriate staff as determined by the Commissioner to 
     discuss the determination.
       ``(2) Timing of final agency action on petitions.--
       ``(A) In general.--Notwithstanding a determination made by 
     the Secretary under paragraph (1)(A)(iii), the Secretary 
     shall take final agency action with respect to a petition not 
     later than 180 days of submission of that petition unless the 
     Secretary determines, prior to the date that is 180 days 
     after the date of submission of the petition, that a delay is 
     necessary to protect the public health.
       ``(B) Determination of delay.--With respect to a 
     determination by the Secretary under subparagraph (A) that a 
     delay is necessary to protect the public health the following 
     shall apply:
       ``(i) Not later than 5 days after making the determination 
     under subparagraph (A), the Secretary shall publish on the 
     Internet website of the Food and Drug Administration a 
     detailed statement providing the reasons underlying the 
     determination. The detailed statement should include the 
     state of the review of the petition, the specific outstanding 
     issues that still need to be resolved, a proposed timeframe 
     to resolve the issues, and any additional information that 
     has been requested by the Secretary of the petitioner or 
     needed by the Secretary in order to resolve the petition and 
     not further delay an application filed under subsection 
     (b)(2) or (j).
       ``(ii) Not later than 10 days after making the 
     determination under subparagraph (A), the Secretary shall 
     provide notice to the sponsor of the pending application 
     submitted under subsection (b)(2) or (j) and provide an 
     opportunity for a meeting with appropriate staff as 
     determined by the Commissioner to discuss the determination.
       ``(3) Verifications.--
       ``(A) Petitions for review.--The Secretary shall not accept 
     a petition for review unless it is signed and contains the 
     following verification: `I certify that, to my best knowledge 
     and belief: (a) this petition includes all information and 
     views upon which the petition relies; (b) this petition 
     includes representative data and/or information known to the 
     petitioner which are unfavorable to the petition; and (c) 
     information upon which I have based the action requested 
     herein first became known to the party on whose behalf this 
     petition is filed on or about __________. I received or 
     expect to receive payments, including cash and other forms of 
     consideration, from the following persons or organizations to 
     file this petition: ________. I verify under penalty of 
     perjury that the foregoing is true and correct.', with the 
     date of the filing of such petition and the signature of the 
     petitioner inserted in the first and second blank space, 
     respectively.
       ``(B) Supplemental information.--The Secretary shall not 
     accept for review any supplemental information or comments on 
     a petition unless the party submitting such information or 
     comments does so in written form and that the subject 
     document is signed and contains the following verification: 
     `I certify that, to my best knowledge and belief: (a) I have 
     not intentionally delayed submission of this document or its 
     contents; and (b) the information upon which I have based the 
     action requested herein first became known to me on or about 
     __________. I received or expect to receive payments, 
     including cash and other forms of consideration, from the 
     following persons or organizations to submit this information 
     or its contents: _____. I verify under penalty of perjury 
     that the foregoing is true and correct.', with the date of 
     the submission of such document and the signature of the 
     petitioner inserted in the first and second blank space, 
     respectively.
       ``(4) Annual report on delays in approvals per petition.--
     The Secretary shall annually submit to the Congress a report 
     that specifies--
       ``(A) the number of applications under subsection (b)(2) 
     and (j) that were approved during the preceding 1-year 
     period;
       ``(B) the number of petitions that were submitted during 
     such period;
       ``(C) the number of applications whose effective dates were 
     delayed by petitions during such period and the number of 
     days by which the applications were so delayed; and
       ``(D) the number of petitions that were filed under this 
     subsection that were deemed by the Secretary under paragraph 
     (1)(A)(iii) to require delaying an application under 
     subsection (b)(2) or (j) and the number of days by which the 
     applications were so delayed.
       ``(5) Exception.--This subsection does not apply to a 
     petition that is made by the sponsor of the application under 
     subsection (b)(2) or (j) and that seeks only to have the 
     Secretary take or refrain from taking any form of action with 
     respect to that application.
       ``(6) Report by inspector general.--The Office of Inspector 
     General of the Department of Health and Human Services shall 
     issue a report not later than 2 years after the date of 
     enactment of this subsection evaluating evidence of the 
     compliance of the Food and Drug Administration with the 
     requirement that the consideration by the Secretary of 
     petitions that do not raise public health concerns remain 
     separate and apart from the review and approval of an 
     application submitted under subsection (b)(2) or (j).
       ``(7) Definition.--For purposes of this subsection, the 
     term `petition' includes any request for an action described 
     in paragraph (1)(A)(i) to the Secretary, without regard to 
     whether the request is characterized as a petition.''.

                                 ______
                                 
  SA 1047. Mr. ROBERTS (for himself, Mr. Harkin, Mr. Burr, and Mr. 
Coburn) 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 subparagraphs (E) and (F) of section 505(o)(5) of 
     the Federal Food, Drug, and Cosmetic Act, as added by this 
     Act, and insert the following:
       ``(E) Specific disclosures.--
       ``(i) Serious risk; safety protocol.--If the Secretary 
     determines that advertisements lacking a specific disclosure 
     about a serious risk listed in the labeling of a drug or 
     about a protocol to ensure safe use described in the labeling 
     of the drug would be false or misleading, the risk evaluation 
     and mitigation strategy for the drug may require that the 
     applicant include in advertisements of the drug such 
     disclosure.
       ``(ii) Date of approval.--If the Secretary determines that 
     advertisements lacking a specific disclosure of the date a 
     drug was approved and disclosure of a serious risk would be 
     false or misleading, the risk evaluation and mitigation 
     strategy for the drug may require that the applicant include 
     in advertisements of the drug such disclosure.
       ``(iii) Specification of advertisements.--The Secretary may 
     specify the advertisements required to include a specific 
     disclosure under clause (i) or (ii).
       ``(iv) Required safety surveillance.--If the approved risk 
     evaluation and mitigation strategy for a drug requires the 
     specific disclosure under clause (ii), the Secretary shall--

       ``(I) consider identifying and assessing all serious risks 
     of using the drug to be a priority safety question under 
     subsection (k)(3)(B);
       ``(II) not less frequently than every 3 months, evaluate 
     the reports under subsection (k)(1) and the routine active 
     surveillance as available under subsection (k)(3) with 
     respect to such priority drug safety question to determine 
     whether serious risks that might occur among patients 
     expected to be treated with the drug have been adequately 
     identified and assessed;
       ``(III) remove such specific disclosure requirement as an 
     element of such strategy if such serious risks have been 
     adequately identified and assessed; and
       ``(IV) consider whether a specific disclosure under clause 
     (i) should be required.

       On page 101, strike lines 7 through 9.
       At the end of the bill, add the following:

     SEC. __. CIVIL PENALTIES; DIRECT-TO-CONSUMER ADVERTISEMENT.

       (a) Civil 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)(1) Any applicant (as such term is used in section 
     505(o)) who disseminates a direct-to-consumer advertisement 
     for a prescription drug that is false or misleading and a 
     violation of section 502(n) shall be liable to the United 
     States for a civil penalty in an amount not to exceed 
     $150,000 for the first such violation in any 3-year period, 
     and not to exceed $300,000 for each subsequent violation 
     committed after the applicant has been penalized under this 
     paragraph any time in the preceding 3-year period. For the 
     purposes of this paragraph, repeated dissemination of the 
     same or similar advertisement prior to the receipt of the 
     written notice referred to in paragraph (2) for such 
     advertisements shall be considered as 1 violation.

[[Page 11394]]

       ``(2) A civil penalty under paragraph (1) shall be assessed 
     by the Secretary by an order made on the record after 
     providing written notice to the applicant to be assessed a 
     civil penalty and an opportunity for a hearing in accordance 
     with this paragraph and section 554 of title 5, United States 
     Code. If upon receipt of the written notice, the applicant to 
     be assessed a civil penalty objects and requests a hearing, 
     then in the course of any investigation related to such 
     hearing, the Secretary may issue subpoenas requiring the 
     attendance and testimony of witnesses and the production of 
     evidence that relates to the matter under investigation, 
     including information pertaining to the factors described in 
     paragraph (3).
       ``(3) Upon the request of the applicant to be assessed a 
     civil penalty, the Secretary, in determining the amount of a 
     civil penalty, shall take into account the nature, 
     circumstances, extent, and gravity of the violation or 
     violations, including the following factors:
       ``(A) Whether the applicant submitted the advertisement or 
     a similar advertisement for review under section 736A.
       ``(B) Whether the applicant submitted the advertisement for 
     prereview if required under section 505(o)(5)(D).
       ``(C) Whether, after submission of the advertisement as 
     described in subparagraph (A) or (B), the applicant 
     disseminated the advertisement before the end of the 45-day 
     comment period.
       ``(D) Whether the applicant failed to incorporate any 
     comments made by the Secretary with regard to the 
     advertisement or a similar advertisement into the 
     advertisement prior to its dissemination.
       ``(E) Whether the applicant ceased distribution of the 
     advertisement upon receipt of the written notice referred to 
     in paragraph (2) for such advertisement.
       ``(F) Whether the applicant had the advertisement reviewed 
     by qualified medical, regulatory, and legal reviewers prior 
     to its dissemination.
       ``(G) Whether the violations were material.
       ``(H) Whether the applicant who created the advertisement 
     acted in good faith.
       ``(I) Whether the applicant who created the advertisement 
     has been assessed a civil penalty under this provision within 
     the previous 1-year period.
       ``(J) The scope and extent of any voluntary, subsequent 
     remedial action by the applicant.
       ``(K) Such other matters, as justice may require.
       ``(4)(A) Subject to subparagraph (B), no applicant shall be 
     required to pay a civil penalty under paragraph (1) if the 
     applicant submitted the advertisement to the Secretary and 
     disseminated such advertisement after incorporating any 
     comment received from the Secretary.
       ``(B) The Secretary may retract or modify any prior 
     comments the Secretary has provided to an advertisement 
     submitted to the Secretary based on new information or 
     changed circumstances, so long as the Secretary provides 
     written notice to the applicant of the new views of the 
     Secretary on the advertisement and provides a reasonable time 
     for modification or correction of the advertisement prior to 
     seeking any civil penalty under paragraph (1).
       ``(5) The Secretary may compromise, modify, remit, with or 
     without conditions, any civil penalty which may be assessed 
     under paragraph (1). The amount of such penalty, when finally 
     determined, or the amount charged upon in compromise, may be 
     deducted from any sums owned by the United States to the 
     applicant charged.
       ``(6) Any applicant who requested, in accordance with 
     paragraph (2), a hearing with respect to the assessment of a 
     civil penalty and who is aggrieved by an order assessing a 
     civil penalty, may file a petition for de novo judicial 
     review of such order with the United States Court of Appeals 
     for the District of Columbia Circuit or for any other circuit 
     in which such applicant resides or transacts business. Such a 
     petition may only be filed within the 60-day period beginning 
     on the date the order making such assessments was issued.
       ``(7) If any applicant fails to pay an assessment of a 
     civil penalty--
       ``(A) after the order making the assessment becomes final, 
     and if such applicant does not file a petition for judicial 
     review of the order in accordance with paragraph (6); or
       ``(B) after a court in an action brought under paragraph 
     (6) has entered a final judgment in favor of the Secretary,
     the Attorney General shall recover the amount assessed (plus 
     interest at currently prevailing rates from the date of the 
     expiration of the 60-day period referred to in paragraph (6) 
     or date of such final judgment, as the case may be) in an 
     action brought in any appropriate district court of the 
     United States. In such an action, the validity, amount, and 
     appropriateness of such penalty shall not be subject to 
     review.''.
       (b) Direct-to-Consumer Advertisement.--
       (1) In general.--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 the case of an 
     advertisement for a prescription drug presented directly to 
     consumers in television or radio format that states the name 
     of the drug and its conditions of use, the major statement 
     relating to side effects, contraindications, and 
     effectiveness referred to in the previous sentence shall be 
     stated in a clear and conspicuous (neutral) manner.''.
       (2) Regulations to determine neutral manner.--The Secretary 
     of Health and Human Services shall by regulation establish 
     standards for determining whether a major statement, relating 
     to side effects, contraindications, and effectiveness of a 
     drug, described in section 502(n) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 352(n)) (as amended by paragraph 
     (1)) is presented in the manner required under such section.

                                 ______
                                 
  SA 1048. Ms. SNOWE 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 appropriate place, insert the following:

     SEC. __. MARKETING OF CERTAIN CRUSTACEANS.

       (a) In General.--Notwithstanding any other provision of 
     law, for purposes of the Federal Food, Drug, and, Costmetic 
     Act (21 U.S.C. 301 et seq.) the term ``lobster'' may not be 
     used to label or advertise the sale of any seafood product 
     from the infraorder Garidea or Anomura.
       (b) Misbranded Food.--Section 403 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 343) is amended by adding 
     at the end the following:
       (y) Lobster.--If it purports to be, or is represented as 
     being, lobster but is from the infraorder Caridea or 
     Anomura.''.
                                 ______
                                 
  SA 1049. Mr. ENZI (for himself and Mr. Kennedy) 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:

       Beginning on page 104, strike line 23 and all that follows 
     through line 14 on page 105 and insert the following:
       ``(II) the amount equal to one-fifth of the excess amount 
     in item (bb), provided that--

       ``(aa) the amount of the total appropriation for the Food 
     and Drug Administration for such fiscal year (excluding the 
     amount of fees appropriated for such fiscal year) exceeds the 
     amount of the total appropriation for the Food and Drug 
     Administration for fiscal year 2007 (excluding the amount of 
     fees appropriated for such fiscal year), adjusted as provided 
     under subsection (c)(1); and
       ``(bb) the amount of the total appropriations for the 
     process of human drug review at the Food and Drug 
     Administration for such fiscal year (excluding the amount of 
     fees appropriated for such fiscal year) exceeds the amount of 
     appropriations for the process of human drug review at the 
     Food and Drug Administration for fiscal year 2007 (excluding 
     the amount of fees appropriated for such fiscal year), 
     adjusted as provided under subsection (c)(1).

     In making the adjustment under subclause (II) for any fiscal 
     year 2008 through 2012, subsection (c)(1) shall be applied by 
     substituting `2007' for `2008.'''.
                                 ______
                                 
  SA 1050. Mr. ENZI (for himself and Mr. Kennedy) 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, add the following:

     SEC. __. COLOR CERTIFICATION REPORTS.

       Section 721 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 379e) is amended by adding at the end the following:
       ``(g) Color Certification Reports.--Not later than--
       ``(1) 90 days after the close of a fiscal year in which 
     color certification fees are collected, the Secretary shall 
     submit to Congress a performance report for such fiscal year 
     on the number of batches of color additives approved, the 
     average turn around time for approval, and quantifiable goals 
     for improving laboratory efficiencies; and
       ``(2) 120 days after the close of a fiscal year in which 
     color certification fees are collected, the Secretary shall 
     submit to Congress a financial report for such fiscal year 
     that includes all fees and expenses of the color 
     certification program, the balance remaining in the fund at 
     the end of the fiscal year, and anticipated costs during the 
     next fiscal year for equipment needs and laboratory 
     improvements of such program.''.

                                 ______
                                 
  SA 1051. Mr. STEVENS (for himself and Ms. Murkowski) submitted an 
amendment intended to be proposed by

[[Page 11395]]

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, add the following:

     SEC. __. CONSULTATION REGARDING GENETICALLY ENGINEERED 
                   SEAFOOD PRODUCTS.

       The Commissioner of Food and Drugs shall consult with the 
     Assistant Administrator of the National Marine Fisheries 
     Service of the National Oceanic and Atmospheric 
     Administration before granting final approval to use or 
     produce a genetically engineered seafood product.
                                 ______
                                 
  SA 1052. Mr. CORKER 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. __. PROHIBITION ON COMMINGLING.

       ``(a) In General.--Notwithstanding any other provision of 
     this Act (or an amendment made by this Act) a registered 
     importer shall not commingle a prescription drug imported 
     into the United States under this Act (or amendment) with 
     another prescription drug, regardless of whether such other 
     drug is a domestic prescription drug or a prescription drug 
     from a permitted country.
       ``(b) Label.--A registered importer (including an Internet 
     pharmacy) that dispenses a prescription drug imported from a 
     permitted country shall affix on each dispensed container of 
     the prescription drug the label required under subsection 
     (c), unless such a label is already affixed to the container.
       ``(c) Requirements.--Each prescription drug imported under 
     this Act (or an amendment made by this Act) shall be in a 
     container that bears a label stating, in prominent and 
     conspicuous type--
       ``(1) the following statement: `This drug has been imported 
     from ______.' with the name of the permitted country from 
     which the prescription drug has imported in the blank space; 
     and
       ``(2) that the container complies with any other applicable 
     requirement of this Act.''.

                                 ______
                                 
  SA 1053. Mr. ENZI (for himself, Mr. Kennedy, Mr. Dodd, and Mrs. 
Clinton) 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:

       On page 226, line 4, strike ``later'' and insert ``if the 
     determination made under subsection (d)(3) is made less''.
       On page 228, line 3, strike ``later'' and insert ``if the 
     determination made under subsection (d)(3) is made less''.
       On page 233, line 12, insert ``, such as expertise in child 
     and adolescent psychiatry,'' after ``expertise''.
       On page 233, line 15, strike ``including'' and insert 
     ``which may include''.
       On page 233, between lines 18 and 19, insert the following:
       ``(C) Action by committee.--The committee established under 
     this paragraph may perform a function under this section 
     using appropriate members of the committee under subparagraph 
     (B) and need not convene all members of the committee under 
     subparagraph (B) in order to perform a function under this 
     section.
       ``(D) Documentation of committee action.--The committee 
     established under this paragraph shall document for each 
     function under paragraphs (2) and (3), which members of the 
     committee participated in such function.
       On page 234, line 1, strike ``determine'' and insert ``make 
     a recommendation to the Secretary''.
       On page 235, line 2, strike ``and''.
       On page 235, line 6, strike ``.'';'' and insert ``; and''
       On page 235, between lines 6 and 7, insert the following:
       ``(H) the number of times the committee established under 
     paragraph (1) made a recommendation to the Secretary under 
     paragraph (3), the number of times the Secretary did not 
     follow such a recommendation to accept reports under 
     subsection (d)(3), and the number of times the Secretary did 
     not follow such a recommendation to reject such reports under 
     section (d)(3).
       ``(5) Committee.--The committee established under paragraph 
     (1) is the committee established under section 505B(f)(1).'';
       On page 260, lines 17 through 19, strike ``of a letter, or 
     a written request under section 505A that was declined by the 
     sponsor or holder'' and insert ``of a written request under 
     section 505A that was declined by the sponsor or holder, or a 
     letter referencing such declined written request,''.
       On page 261, line 3, strike ``appropriate'' and insert 
     ``appropriate, for the labeled indication or indications,''.
       On page 263, line 14, insert ``, such as expertise in child 
     and adolescent psychiatry,'' after ``expertise''
       On page 263, between lines 19 and 20, insert the following 
     and redesignate the remaining paragraphs accordingly:
       ``(2) Action by the committee.--The committee established 
     under paragraph (1) may perform a function under this section 
     using appropriate members of the committee under paragraph 
     (1) and need not convene all members of the committee under 
     paragraph (1) in order to perform a function under this 
     section.
       ``(3) Documentation of committee action.--For each drug or 
     biological product, the committee established under this 
     paragraph shall document for each function under paragraph 
     (4) or (5), which members of the committee participated in 
     such function.
       On page 265, between lines 18 and 19, insert the following:
       ``(7) Committee.--The committee established under paragraph 
     (1) is the committee established under section 505A(f)(1).
       On page 289, line 16, strike ``SURVEILLANCES'' and insert 
     ``POSTMARKET SURVEILLANCE''.
       On page 289, line 17, strike ``Surveillances'' and insert 
     ``Surveillance''.
       On page 290, strike lines 9 through 12 and insert the 
     following:
       ``(iii) that is intended to be--

       ``(I) implanted in the human body for more than 1 year; or
       ``(II) a life-sustaining or life-supporting device used 
     outside a device user facility.

       On page 290, line 15, strike ``of an'' and all that follows 
     through ``section 510(k) only for'' on line 19, and insert 
     ``or clearance of''.
                                 ______
                                 
  SA 1054. Mr. FEINGOLD 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. __. PUBLICATION OF ANNUAL REPORTS.

       (a) In General.--The Commissioner on Food and Drugs shall 
     annually submit to Congress and publish on the Internet 
     website of the Food and Drug Administration, a report 
     concerning the results of the Administration's pesticide 
     residue monitoring program, that includes--
       (1) information and analysis similar to that contained in 
     the report entitled ``Food and Drug Administration Pesticide 
     Program Residue Monitoring 2003'' as released in June of 
     2005;
       (2) based on an analysis of previous samples, an 
     identification of products or countries (for imports) that 
     require special attention and additional study based on a 
     comparison with equivalent products manufactured, 
     distributed, or sold in the U.S. (including details on the 
     plans for such additional studies), including in the initial 
     report (and subsequent reports as determined necessary) the 
     results and analysis of the Ginseng Dietary Supplements 
     Special Survey as described on page 13 of the report entitled 
     ``Food and Drug Administration Pesticide Program Residue 
     Monitoring 2003'';
       (3) information on the relative number of interstate and 
     imported shipments of each tested commodity that were 
     sampled, including recommendations on whether sampling is 
     statistically significant, provides confidence intervals or 
     other related statistical information, and whether the number 
     of samples should be increased and the details of any plans 
     to provide for such increase; and
       (4) a description of whether certain commodities are being 
     improperly imported as another commodity, including a 
     description of additional steps that are being planned to 
     prevent such smuggling.
       (b) Initial Reports.--Annual reports under subsection (a) 
     for fiscal years 2004 through 2006 may be combined into a 
     single report, by not later than June 1, 2008, for purposes 
     of publication under subsection (a). Thereafter such reports 
     shall be completed by June 1 of each year for the data 
     collected for the year that was 2-years prior to the year in 
     which the report is published.
       (c) Memorandum of Understanding.--The Commissioner of Food 
     and Drugs, the Administrator of the Food Safety and 
     Inspection Service, the Department of Commerce, and the head 
     of the Agricultural Marketing Service shall enter into a 
     memorandum of understanding to permit inclusion of data in 
     the reports under subsection (a) relating to testing carried 
     out by the Food Safety and Inspection Service and the 
     Agricultural Marketing Service on meat, poultry, eggs, and 
     certain raw agricultural products, respectively.

                                 ______
                                 
  SA 1055. 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:


[[Page 11396]]

       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 to preserve the 
     appearance of fresh meat may create any health risks, or 
     mislead consumers.

                                 ______
                                 
  SA 1056. Mr. REED (for himself, and Mr. Isakson) 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. __. REPORT BY THE FOOD AND DRUG ADMINISTRATION REGARDING 
                   LABELING INFORMATION ON THE RELATIONSHIP 
                   BETWEEN THE USE OF INDOOR TANNING DEVICES AND 
                   DEVELOPMENT OF SKIN CANCER OR OTHER SKIN 
                   DAMAGE.

       (a) In General.--The Secretary of Health and Human Services 
     (referred to in this section as the ``Secretary''), acting 
     through the Commissioner of Food and Drugs, shall determine--
       (1) whether the labeling requirements for indoor tanning 
     devices, including the positioning requirements, provide 
     sufficient information to consumers regarding the risks that 
     the use of such devices pose for the development of 
     irreversible damage to the eyes and skin, including skin 
     cancer; and
       (2)(A) whether modifying the warning label required on 
     tanning beds to read, ``Ultraviolet radiation can cause skin 
     cancer'', or any other additional warning, would communicate 
     the risks of indoor tanning more effectively; or
       (B) whether there is no warning that would be capable of 
     adequately communicating such risks.
       (b) Consumer Testing.--In making the determinations under 
     subsection (a), the Secretary shall conduct appropriate 
     consumer testing, using the best available methods for 
     determining consumer understanding of label warnings.
       (c) Public Hearings; Public Comment.--The Secretary shall 
     hold public hearings and solicit comments from the public in 
     making the determinations under subsection (a).
       (d) Report.--Not later than 1 year after the date of the 
     enactment of this Act, the Secretary shall submit to the 
     Congress a report that provides the determinations under 
     subsection (a). In addition, the Secretary shall include in 
     the report the measures being implemented by the Secretary to 
     significantly reduce the risks associated with indoor tanning 
     devices.

  SA 1057. 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
       ``(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--

[[Page 11397]]

       ``(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.
       ``(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.--

[[Page 11398]]

       ``(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.
       ``(iv) Excess fees.--Any amount collected by the Secretary 
     under this paragraph for a fiscal year that is in excess of 
     the costs of enforcing the requirements of this section for 
     such fiscal year shall be deposited in the Treasury.
       ``(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 133 percent 
     of 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 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:

[[Page 11399]]

       ``(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 1058. Mr. DeMINT (for himself, Mr. Coburn, and Mr. Martinez) 
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. __. SENSE OF THE SENATE REGARDING CERTAIN PATENT 
                   INFRINGEMENTS.

       (a) Findings.--The Senate makes the following findings:
       (1) The value of American innovation in developing life-
     saving prescription drugs saves millions of lives around the 
     world each year.
       (2) The protection of intellectual property is vital to the 
     continued development of new and life-saving drugs and future 
     growth of the United States economy.
       (3) In order to maintain the global competitiveness of the 
     United States, the United States Trade Representative's 
     Office of Intellectual Property and Innovation develops and 
     implements trade policy in support of vital American 
     innovations, including innovation in the pharmaceutical and 
     medical technology industries.
       (4) The United States Trade Representative also provides 
     trade policy leadership and expertise across the full range 
     of interagency initiatives to enhance protection and 
     enforcement of intellectual property rights.
       (5) When other countries do not respect the intellectual 
     property of American drug companies, all patients suffer 
     because of diminished incentives to develop new life-saving 
     medications and the American economy is unfairly harmed.
       (6) Strong intellectual property protection, including 
     patent, copyright, trademark, and data protection plays an 
     integral role in fostering economic growth and development 
     and ensuring patient access to the most effective medicines 
     around the world.
       (7) Certain countries have engaged in unfair price 
     manipulation and abuse of compulsory licensing. This results 
     in Americans bearing the majority of research and development 
     costs for the world, undermines the value of existing United 
     States pharmaceutical patents and could impede access to 
     important therapies.
       (8) There is a growing global threat of counterfeit 
     medicines and increased need for the United States Trade 
     Representative and other United States agencies to use 
     available trade policy measures to strengthen laws and 
     enforcement abroad to prevent harm to United States patients 
     and patients around the world.
       (b) Sense of the Senate.--It is the sense of the Senate 
     that--
       (1) the United States Trade Representative should use all 
     the tools at the disposal of the Trade Representative to deal 
     with violations of intellectual property rights, including--
       (A) bilateral engagement with United States trading 
     partners;
       (B) transparency of the annual ``Special 301'' review and 
     reviews of compliance with the intellectual property 
     requirements of countries with respect to which the United 
     States grants trade preferences;
       (C) negotiation of intellectual property provisions as part 
     of bilateral and regional trade agreements; and
       (D) multilateral engagement through the World Trade 
     Organization (WTO); and
       (2) the United States Trade Representative should develop 
     and implement a strategic plan to address the problem of 
     countries that infringe upon American pharmaceutical 
     intellectual property rights and the problem of countries 
     that engage in price manipulation.
                                 ______
                                 
  SA 1059. Mr. SESSIONS (for himself, Mrs. Lincoln, Mr. Cochran, Mr. 
Pryor, Mr. Lott, and Mr. Shelby) submitted an amendment intended to be 
proposed by him to the bill S. 1082, to amend the Federal Food, Drug, 
and Cosmetic Act

[[Page 11400]]

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. __. ENHANCED AQUACULTURE AND SEAFOOD INSPECTION.

       (a) Findings.--Congress finds the following:
       (1) In 2007, there has been an overwhelming increase in the 
     volume of aquaculture and seafood that has been found to 
     contain substances that are not approved for use in food in 
     the United States.
       (2) As of May 2007, inspection programs are not able to 
     satisfactorily accomplish the goals of ensuring the food 
     safety of the United States.
       (3) To protect the health and safety of consumers in the 
     United States, the ability of the Secretary of Health and 
     Human Services to perform inspection functions must be 
     enhanced.
       (b) Heightened Inspections.--
       (1) In general.--The Secretary of Health and Human Services 
     (referred to in this section as the ``Secretary'') shall, by 
     regulation, enhance, as necessary, the inspection regime of 
     the Food and Drug Administration for aquaculture and seafood, 
     consistent with obligations of the United States under 
     international agreements and United States law.
       (2) Content.--The Secretary shall ensure that the 
     regulations promulgated under paragraph (1) to enhance the 
     inspection regime--
       (A) ensure that aquaculture and seafood products are not 
     contaminated with substances that are not approved for use in 
     food in the United States;
       (B) include the authority to refuse imports of such 
     products from a foreign facility if a requested inspection of 
     the foreign facility is refused or unnecessarily delayed;
       (C) take into account whether the United States has a 
     cooperative agreement regarding aquaculture and seafood 
     inspection; and
       (D) provide for an assessment of the risk associated with 
     particular contaminants.
       (c) Report to Congress.--Not later than 90 days after the 
     date of enactment of this Act, the Secretary shall submit to 
     Congress a report that describes--
       (1) the specifics of the aquaculture and seafood inspection 
     program; and
       (2) the feasibility of developing a traceability system for 
     all catfish and seafood products, both domestic and imported, 
     for the purpose of identifying the processing plant of origin 
     of such products.
       (d) Partnerships With States.--Upon the request by any 
     State, the Secretary may enter into partnership agreements, 
     as soon as practicable after the request is made, to 
     implement inspection programs regarding the importation of 
     aquaculture and seafood.
       (e) Authorization of Appropriations.--There are authorized 
     to be appropriated such sums as may be necessary to carry out 
     this section.
                                 ______
                                 
  SA 1060. Mr. HATCH (for himself and Mr. Kennedy) 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. __. FOOD AND DRUG ADMINISTRATION FUNDING SUBMISSION.

       Subchapter A of chapter VII of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 371 et seq.), as amended by this Act, 
     is amended by adding at the end the following:

     ``SEC. 714. FOOD AND DRUG ADMINISTRATION FUNDING SUBMISSION.

       ``For each of fiscal years 2009 through 2013, the 
     Commissioner of Food and Drugs shall prepare and submit, 
     directly to the President for review and transmittal to 
     Congress, an annual Food and Drug Administration funding 
     submission estimate (including the number and type of 
     personnel needs for the Food and Drug Administration), after 
     reasonable opportunity for comment (but without change) by 
     the Secretary.''.

                          ____________________