[Congressional Record (Bound Edition), Volume 148 (2002), Part 10]
[Senate]
[Pages 13269-13274]
[From the U.S. Government Publishing Office, www.gpo.gov]




                           TEXT OF AMENDMENTS

  SA 4299. Mr. REID (for Mr. Dorgan (for himself, Mr. Wellstone, Mr. 
Jeffords, Ms. Stabenow, Ms. Collins, Mr. Levin, Mr. Johnson, Mr. 
Miller, Mr. Durbin, Mr. Feingold, and Mr. Harkin)) proposed an 
amendment to the bill S. 812), to amend the Federal Food, Drug, and 
Cosmetic Act to provide greater access to affordable pharmaceuticals; 
and follows:

                                 S. 812

       At the end, add the following:

              TITLE __--IMPORTATION OF PRESCRIPTION DRUGS

     SEC. __01. IMPORTATION OF PRESCRIPTION DRUGS.

       (a) In General.--Chapter VIII of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 381 et seq.) is amended by 
     striking section 804 and inserting the following:

     ``SEC. 804. IMPORTATION OF PRESCRIPTION DRUGS.

       ``(a) Definitions.--In this section:
       ``(1) Importer.--The term `importer' means a pharmacist or 
     wholesaler.
       ``(2) Pharmacist.--The term `pharmacist' means a person 
     licensed by a State to practice pharmacy, including the 
     dispensing and selling of prescription drugs.
       ``(3) 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; or
       ``(E) a drug that is inhaled during surgery.
       ``(4) 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.
       ``(5) 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).
       ``(B) Exclusion.--The term `wholesaler' does not include a 
     person authorized to import drugs under section 801(d)(1).
       ``(b) Regulations.--The Secretary, after consultation with 
     the United States Trade Representative and the Commissioner 
     of Customs, shall promulgate regulations permitting 
     pharmacists and wholesalers to import prescription drugs from 
     Canada into the United States.
       ``(c) Limitation.--The regulations under subsection (b) 
     shall--
       ``(1) require that safeguards be in place to ensure that 
     each prescription drug imported under the regulations 
     complies with section 505 (including with respect to being 
     safe and effective for the intended use of the prescription 
     drug), with sections 501 and 502, and with other applicable 
     requirements of this Act;
       ``(2) require that an importer of a prescription drug under 
     the regulations comply with subsections (d)(1) and (e); and
       ``(3) contain any additional provisions determined by the 
     Secretary to be appropriate as a safeguard to protect the 
     public health or as a means to facilitate the importation of 
     prescription drugs.
       ``(d) Information and Records.--
       ``(1) In general.--The regulations under subsection (b) 
     shall require an importer of a prescription drug under 
     subsection (b) to submit to the Secretary the following 
     information and documentation:
       ``(A) The name and quantity of the active ingredient of the 
     prescription drug.
       ``(B) A description of the dosage form of the prescription 
     drug.
       ``(C) The date on which the prescription drug is shipped.
       ``(D) The quantity of the prescription drug that is 
     shipped.
       ``(E) The point of origin and destination of the 
     prescription drug.
       ``(F) The price paid by the importer for the prescription 
     drug.
       ``(G) Documentation from the foreign seller specifying--
       ``(i) the original source of the prescription drug; and
       ``(ii) the quantity of each lot of the prescription drug 
     originally received by the seller from that source.
       ``(H) The lot or control number assigned to the 
     prescription drug by the manufacturer of the prescription 
     drug.
       ``(I) The name, address, telephone number, and professional 
     license number (if any) of the importer.
       ``(J)(i) In the case of a prescription drug that is shipped 
     directly from the first foreign recipient of the prescription 
     drug from the manufacturer:
       ``(I) Documentation demonstrating that the prescription 
     drug was received by the recipient from the manufacturer and 
     subsequently shipped by the first foreign recipient to the 
     importer.
       ``(II) Documentation of the quantity of each lot of the 
     prescription drug received by

[[Page 13270]]

     the first foreign recipient demonstrating that the quantity 
     being imported into the United States is not more than the 
     quantity that was received by the first foreign recipient.
       ``(III)(aa) In the case of an initial imported shipment, 
     documentation demonstrating that each batch of the 
     prescription drug in the shipment was statistically sampled 
     and tested for authenticity and degradation.
       ``(bb) In the case of any subsequent shipment, 
     documentation demonstrating that a statistically valid sample 
     of the shipment was tested for authenticity and degradation.
       ``(ii) In the case of a prescription drug that is not 
     shipped directly from the first foreign recipient of the 
     prescription drug from the manufacturer, documentation 
     demonstrating that each batch in each shipment offered for 
     importation into the United States was statistically sampled 
     and tested for authenticity and degradation.
       ``(K) Certification from the importer or manufacturer of 
     the prescription drug that the prescription drug--
       ``(i) is approved for marketing in the United States; and
       ``(ii) meets all labeling requirements under this Act.
       ``(L) Laboratory records, including complete data derived 
     from all tests necessary to ensure that the prescription drug 
     is in compliance with established specifications and 
     standards.
       ``(M) Documentation demonstrating that the testing required 
     by subparagraphs (J) and (L) was conducted at a qualifying 
     laboratory.
       ``(N) Any other information that the Secretary determines 
     is necessary to ensure the protection of the public health.
       ``(2) Maintenance by the secretary.--The Secretary shall 
     maintain information and documentation submitted under 
     paragraph (1) for such period of time as the Secretary 
     determines to be necessary.
       ``(e) Testing.--The regulations under subsection (b) shall 
     require--
       ``(1) that testing described in subparagraphs (J) and (L) 
     of subsection (d)(1) be conducted by the importer or by the 
     manufacturer of the prescription drug at a qualified 
     laboratory;
       ``(2) if the tests are conducted by the importer--
       ``(A) that information needed to--
       ``(i) authenticate the prescription drug being tested; and
       ``(ii) confirm that the labeling of the prescription drug 
     complies with labeling requirements under this Act;
     be supplied by the manufacturer of the prescription drug to 
     the pharmacist or wholesaler; and
       ``(B) that the information supplied under subparagraph (A) 
     be kept in strict confidence and used only for purposes of 
     testing or otherwise complying with this Act; and
       ``(3) may include such additional provisions as the 
     Secretary determines to be appropriate to provide for the 
     protection of trade secrets and commercial or financial 
     information that is privileged or confidential.
       ``(f) Registration of Foreign Sellers.--Any establishment 
     within Canada engaged in the distribution of a prescription 
     drug that is imported or offered for importation into the 
     United States shall register with the Secretary the name and 
     place of business of the establishment.
       ``(g) Approved Labeling.--The manufacturer of a 
     prescription drug shall provide an importer written 
     authorization for the importer to use, at no cost, the 
     approved labeling for the prescription drug.
       ``(h) Prohibition of Discrimination.--
       ``(1) In general.--It shall be unlawful for a manufacturer 
     of a prescription drug to discriminate against, or cause any 
     other person to discriminate against, a pharmacist or 
     wholesaler that purchases or offers to purchase a 
     prescription drug from the manufacturer or from any person 
     that distributes a prescription drug manufactured by the drug 
     manufacturer.
       ``(2) Discrimination.--For the purposes of paragraph (1), a 
     manufacturer of a prescription drug shall be considered to 
     discriminate against a pharmacist or wholesaler if the 
     manufacturer enters into a contract for sale of a 
     prescription drug, places a limit on supply, or employs any 
     other measure, that has the effect of--
       ``(A) providing pharmacists or wholesalers access to 
     prescription drugs on terms or conditions that are less 
     favorable than the terms or conditions provided to a foreign 
     purchaser (other than a charitable or humanitarian 
     organization) of the prescription drug; or
       ``(B) restricting the access of pharmacists or wholesalers 
     to a prescription drug that is permitted to be imported into 
     the United States under this section.
       ``(i) Charitable Contributions.--Notwithstanding any other 
     provision of this section, section 801(d)(1) continues to 
     apply to a prescription drug that is donated or otherwise 
     supplied at no charge 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.
       ``(j) Waiver Authority for Importation by Individuals.--
       ``(1) Declarations.--Congress declares that in the 
     enforcement against individuals of the prohibition of 
     importation of prescription drugs and devices, the Secretary 
     should--
       ``(A) focus enforcement on cases in which the importation 
     by an individual poses a significant threat to public health; 
     and
       ``(B) exercise discretion to permit individuals to make 
     such importations in circumstances in which--
       ``(i) the importation is clearly for personal use; and
       ``(ii) the prescription drug or device imported does not 
     appear to present an unreasonable risk to the individual.
       ``(2) Waiver authority.--
       ``(A) In general.--The Secretary may grant to individuals, 
     by regulation or on a case-by-case basis, a waiver of the 
     prohibition of importation of a prescription drug or device 
     or class of prescription drugs or devices, under such 
     conditions as the Secretary determines to be appropriate.
       ``(B) Guidance on case-by-case waivers.--The Secretary 
     shall publish, and update as necessary, guidance that 
     accurately describes circumstances in which the Secretary 
     will consistently grant waivers on a case-by-case basis under 
     subparagraph (A), so that individuals may know with the 
     greatest practicable degree of certainty whether a particular 
     importation for personal use will be permitted.
       ``(3) Drugs imported from canada.--In particular, the 
     Secretary shall by regulation grant individuals a waiver to 
     permit individuals to import into the United States a 
     prescription drug that--
       ``(A) is imported from a licensed pharmacy for personal use 
     by an individual, not for resale, in quantities that do not 
     exceed a 90-day supply;
       ``(B) is accompanied by a copy of a valid prescription;
       ``(C) is imported from Canada, from a seller registered 
     with the Secretary;
       ``(D) is a prescription drug approved by the Secretary 
     under chapter V;
       ``(E) is in the form of a final finished dosage that was 
     manufactured in an establishment registered under section 
     510; and
       ``(F) is imported under such other conditions as the 
     Secretary determines to be necessary to ensure public safety.
       ``(k) Studies; Reports.--
       ``(1) By the institute of medicine of the national academy 
     of sciences.--
       ``(A) Study.--
       ``(i) In general.--The Secretary shall request that the 
     Institute of Medicine of the National Academy of Sciences 
     conduct a study of--

       ``(I) importations of prescription drugs made under the 
     regulations under subsection (b); and
       ``(II) information and documentation submitted under 
     subsection (d).

       ``(ii) Requirements.--In conducting the study, the 
     Institute of Medicine shall--

       ``(I) evaluate the compliance of importers with the 
     regulations under subsection (b);
       ``(II) compare the number of shipments under the 
     regulations under subsection (b) during the study period that 
     are determined to be counterfeit, misbranded, or adulterated, 
     and compare that number with the number of shipments made 
     during the study period within the United States that are 
     determined to be counterfeit, misbranded, or adulterated; and
       ``(III) consult with the Secretary, the United States Trade 
     Representative, and the Commissioner of Patents and 
     Trademarks to evaluate the effect of importations under the 
     regulations under subsection (b) on trade and patent rights 
     under Federal law.

       ``(B) Report.--Not later than 2 years after the effective 
     date of the regulations under subsection (b), the Institute 
     of Medicine shall submit to Congress a report describing the 
     findings of the study under subparagraph (A).
       ``(2) By the comptroller general.--
       ``(A) Study.--The Comptroller General of the United States 
     shall conduct a study to determine the effect of this section 
     on the price of prescription drugs sold to consumers at 
     retail.
       ``(B) Report.--Not later than 18 months after the effective 
     date of the regulations under subsection (b), the Comptroller 
     General of the United States shall submit to Congress a 
     report describing the findings of the study under 
     subparagraph (A).
       ``(l) Construction.--Nothing in this section limits the 
     authority of the Secretary relating to the importation of 
     prescription drugs, other than with respect to section 
     801(d)(1) as provided in this section.
       ``(m) Authorization of Appropriations.--There are 
     authorized to be appropriated such sums as are necessary to 
     carry out this section.''.
       (b) Conforming Amendments.--The Federal Food, Drug, and 
     Cosmetic Act is amended--
       (1) in section 301(aa) (21 U.S.C. 331(aa)), by striking 
     ``covered product in violation of section 804'' and inserting 
     ``prescription drug in violation of section 804''; and
       (2) in section 303(a)(6) (21 U.S.C. 333(a)(6), by striking 
     ``covered product pursuant to section 804(a)'' and inserting 
     ``prescription drug under section 804(b)''.
                                  ____

  SA 4300. Mr. REID (for Mr. Dorgan (for himself, Mr. Wellstone, Mr. 
Jeffords, Ms. Stabenow, Ms. Collins, Mr.

[[Page 13271]]

Levin, Mr. Johnson, Mr. Miller, Mr. Durbin, and Mr. Feingold)) proposed 
an amendment to amendment SA 4299 proposed by Mr. Reid (for Mr. Dorgan 
(for himself, Mr. Wellstone, Mr. Jeffords, Ms. Stabenow, Ms. Collins, 
Mr. Levin, Mr. Johnson, Mr. Miller, Mr. Durbin, Mr. Feingold, and Mr. 
Harkin)) to the bill (S. 812) to amend the Federal Food, Drug, and 
Cosmetic Act to provide greater access to affordable pharmaceuticals; 
as follows:
       In the amendment strike all after the first word and insert 
     the following:

                 __--IMPORTATION OF PRESCRIPTION DRUGS

     SEC. __01. IMPORTATION OF PRESCRIPTION DRUGS.

       (a) In General.--Chapter VIII of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 381 et seq.) is amended by 
     striking section 804 and inserting the following:

     ``SEC. 804. IMPORTATION OF PRESCRIPTION DRUGS.

       ``(a) Definitions.--In this section:
       ``(1) Importer.--The term `importer' means a pharmacist or 
     wholesaler.
       ``(2) Pharmacist.--The term `pharmacist' means a person 
     licensed by a State to practice pharmacy, including the 
     dispensing and selling of prescription drugs.
       ``(3) 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; or
       ``(E) a drug that is inhaled during surgery.
       ``(4) 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.
       ``(5) 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).
       ``(B) Exclusion.--The term `wholesaler' does not include a 
     person authorized to import drugs under section 801(d)(1).
       ``(b) Regulations.--The Secretary, after consultation with 
     the United States Trade Representative and the Commissioner 
     of Customs, shall promulgate regulations permitting 
     pharmacists and wholesalers to import prescription drugs from 
     Canada into the United States.
       ``(c) Limitation.--The regulations under subsection (b) 
     shall--
       ``(1) require that safeguards be in place to ensure that 
     each prescription drug imported under the regulations 
     complies with section 505 (including with respect to being 
     safe and effective for the intended use of the prescription 
     drug), with sections 501 and 502, and with other applicable 
     requirements of this Act;
       ``(2) require that an importer of a prescription drug under 
     the regulations comply with subsections (d)(1) and (e); and
       ``(3) contain any additional provisions determined by the 
     Secretary to be appropriate as a safeguard to protect the 
     public health or as a means to facilitate the importation of 
     prescription drugs.
       ``(d) Information and Records.--
       ``(1) In general.--The regulations under subsection (b) 
     shall require an importer of a prescription drug under 
     subsection (b) to submit to the Secretary the following 
     information and documentation:
       ``(A) The name and quantity of the active ingredient of the 
     prescription drug.
       ``(B) A description of the dosage form of the prescription 
     drug.
       ``(C) The date on which the prescription drug is shipped.
       ``(D) The quantity of the prescription drug that is 
     shipped.
       ``(E) The point of origin and destination of the 
     prescription drug.
       ``(F) The price paid by the importer for the prescription 
     drug.
       ``(G) Documentation from the foreign seller specifying--
       ``(i) the original source of the prescription drug; and
       ``(ii) the quantity of each lot of the prescription drug 
     originally received by the seller from that source.
       ``(H) The lot or control number assigned to the 
     prescription drug by the manufacturer of the prescription 
     drug.
       ``(I) The name, address, telephone number, and professional 
     license number (if any) of the importer.
       ``(J)(i) In the case of a prescription drug that is shipped 
     directly from the first foreign recipient of the prescription 
     drug from the manufacturer:
       ``(I) Documentation demonstrating that the prescription 
     drug was received by the recipient from the manufacturer and 
     subsequently shipped by the first foreign recipient to the 
     importer.
       ``(II) Documentation of the quantity of each lot of the 
     prescription drug received by the first foreign recipient 
     demonstrating that the quantity being imported into the 
     United States is not more than the quantity that was received 
     by the first foreign recipient.
       ``(III)(aa) In the case of an initial imported shipment, 
     documentation demonstrating that each batch of the 
     prescription drug in the shipment was statistically sampled 
     and tested for authenticity and degradation.
       ``(bb) In the case of any subsequent shipment, 
     documentation demonstrating that a statistically valid sample 
     of the shipment was tested for authenticity and degradation.
       ``(ii) In the case of a prescription drug that is not 
     shipped directly from the first foreign recipient of the 
     prescription drug from the manufacturer, documentation 
     demonstrating that each batch in each shipment offered for 
     importation into the United States was statistically sampled 
     and tested for authenticity and degradation.
       ``(K) Certification from the importer or manufacturer of 
     the prescription drug that the prescription drug--
       ``(i) is approved for marketing in the United States; and
       ``(ii) meets all labeling requirements under this Act.
       ``(L) Laboratory records, including complete data derived 
     from all tests necessary to ensure that the prescription drug 
     is in compliance with established specifications and 
     standards.
       ``(M) Documentation demonstrating that the testing required 
     by subparagraphs (J) and (L) was conducted at a qualifying 
     laboratory.
       ``(N) Any other information that the Secretary determines 
     is necessary to ensure the protection of the public health.
       ``(2) Maintenance by the secretary.--The Secretary shall 
     maintain information and documentation submitted under 
     paragraph (1) for such period of time as the Secretary 
     determines to be necessary.
       ``(e) Testing.--The regulations under subsection (b) shall 
     require--
       ``(1) that testing described in subparagraphs (J) and (L) 
     of subsection (d)(1) be conducted by the importer or by the 
     manufacturer of the prescription drug at a qualified 
     laboratory;
       ``(2) if the tests are conducted by the importer--
       ``(A) that information needed to--
       ``(i) authenticate the prescription drug being tested; and
       ``(ii) confirm that the labeling of the prescription drug 
     complies with labeling requirements under this Act;

     be supplied by the manufacturer of the prescription drug to 
     the pharmacist or wholesaler; and
       ``(B) that the information supplied under subparagraph (A) 
     be kept in strict confidence and used only for purposes of 
     testing or otherwise complying with this Act; and
       ``(3) may include such additional provisions as the 
     Secretary determines to be appropriate to provide for the 
     protection of trade secrets and commercial or financial 
     information that is privileged or confidential.
       ``(f) Registration of Foreign Sellers.--Any establishment 
     within Canada engaged in the distribution of a prescription 
     drug that is imported or offered for importation into the 
     United States shall register with the Secretary the name and 
     place of business of the establishment.
       ``(g) Suspension of Importation.--The Secretary shall 
     require that importations of a specific prescription drug or 
     importations by a specific importer under subsection (b) be 
     immediately suspended on discovery of a pattern of 
     importation of the prescription drugs or by the importer that 
     is counterfeit or in violation of any requirement under this 
     section or poses an additional risk to the public health, 
     until an investigation is completed and the Secretary 
     determines that the public is adequately protected from 
     counterfeit and violative prescription drugs being imported 
     under subsection (b).
       ``(h) Approved Labeling.--The manufacturer of a 
     prescription drug shall provide an importer written 
     authorization for the importer to use, at no cost, the 
     approved labeling for the prescription drug.
       ``(i) Prohibition of Discrimination.--
       ``(1) In general.--It shall be unlawful for a manufacturer 
     of a prescription drug to discriminate against, or cause any 
     other person to discriminate against, a pharmacist or 
     wholesaler that purchases or offers to purchase a 
     prescription drug from the manufacturer or from any person 
     that distributes a prescription drug manufactured by the drug 
     manufacturer.
       ``(2) Discrimination.--For the purposes of paragraph (1), a 
     manufacturer of a prescription drug shall be considered to 
     discriminate against a pharmacist or wholesaler if the 
     manufacturer enters into a contract for sale of a 
     prescription drug, places a limit on supply, or employs any 
     other measure, that has the effect of--
       ``(A) providing pharmacists or wholesalers access to 
     prescription drugs on terms or conditions that are less 
     favorable than the terms or conditions provided to a foreign 
     purchaser (other than a charitable or humanitarian 
     organization) of the prescription drug; or
       ``(B) restricting the access of pharmacists or wholesalers 
     to a prescription drug that is permitted to be imported into 
     the United States under this section.

[[Page 13272]]

       ``(j) Charitable Contributions.--Notwithstanding any other 
     provision of this section, section 801(d)(1) continues to 
     apply to a prescription drug that is donated or otherwise 
     supplied at no charge 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.
       ``(k) Waiver Authority for Importation by Individuals.--
       ``(1) Declarations.--Congress declares that in the 
     enforcement against individuals of the prohibition of 
     importation of prescription drugs and devices, the Secretary 
     should--
       ``(A) focus enforcement on cases in which the importation 
     by an individual poses a significant threat to public health; 
     and
       ``(B) exercise discretion to permit individuals to make 
     such importations in circumstances in which--
       ``(i) the importation is clearly for personal use; and
       ``(ii) the prescription drug or device imported does not 
     appear to present an unreasonable risk to the individual.
       ``(2) Waiver authority.--
       ``(A) In general.--The Secretary may grant to individuals, 
     by regulation or on a case-by-case basis, a waiver of the 
     prohibition of importation of a prescription drug or device 
     or class of prescription drugs or devices, under such 
     conditions as the Secretary determines to be appropriate.
       ``(B) Guidance on case-by-case waivers.--The Secretary 
     shall publish, and update as necessary, guidance that 
     accurately describes circumstances in which the Secretary 
     will consistently grant waivers on a case-by-case basis under 
     subparagraph (A), so that individuals may know with the 
     greatest practicable degree of certainty whether a particular 
     importation for personal use will be permitted.
       ``(3) Drugs imported from canada.--In particular, the 
     Secretary shall by regulation grant individuals a waiver to 
     permit individuals to import into the United States a 
     prescription drug that--
       ``(A) is imported from a licensed pharmacy for personal use 
     by an individual, not for resale, in quantities that do not 
     exceed a 90-day supply;
       ``(B) is accompanied by a copy of a valid prescription;
       ``(C) is imported from Canada, from a seller registered 
     with the Secretary;
       ``(D) is a prescription drug approved by the Secretary 
     under chapter V;
       ``(E) is in the form of a final finished dosage that was 
     manufactured in an establishment registered under section 
     510; and
       ``(F) is imported under such other conditions as the 
     Secretary determines to be necessary to ensure public safety.
       ``(l) Studies; Reports.--
       ``(1) By the institute of medicine of the national academy 
     of sciences.--
       ``(A) Study.--
       ``(i) In general.--The Secretary shall request that the 
     Institute of Medicine of the National Academy of Sciences 
     conduct a study of--

       ``(I) importations of prescription drugs made under the 
     regulations under subsection (b); and
       ``(II) information and documentation submitted under 
     subsection (d).

       ``(ii) Requirements.--In conducting the study, the 
     Institute of Medicine shall--

       ``(I) evaluate the compliance of importers with the 
     regulations under subsection (b);
       ``(II) compare the number of shipments under the 
     regulations under subsection (b) during the study period that 
     are determined to be counterfeit, misbranded, or adulterated, 
     and compare that number with the number of shipments made 
     during the study period within the United States that are 
     determined to be counterfeit, misbranded, or adulterated; and
       ``(III) consult with the Secretary, the United States Trade 
     Representative, and the Commissioner of Patents and 
     Trademarks to evaluate the effect of importations under the 
     regulations under subsection (b) on trade and patent rights 
     under Federal law.

       ``(B) Report.--Not later than 2 years after the effective 
     date of the regulations under subsection (b), the Institute 
     of Medicine shall submit to Congress a report describing the 
     findings of the study under subparagraph (A).
       ``(2) By the comptroller general.--
       ``(A) Study.--The Comptroller General of the United States 
     shall conduct a study to determine the effect of this section 
     on the price of prescription drugs sold to consumers at 
     retail.
       ``(B) Report.--Not later than 18 months after the effective 
     date of the regulations under subsection (b), the Comptroller 
     General of the United States shall submit to Congress a 
     report describing the findings of the study under 
     subparagraph (A).
       ``(m) Construction.--Nothing in this section limits the 
     authority of the Secretary relating to the importation of 
     prescription drugs, other than with respect to section 
     801(d)(1) as provided in this section.
       ``(n) Authorization of Appropriations.--There are 
     authorized to be appropriated such sums as are necessary to 
     carry out this section.''.
       (b) Conforming Amendments.--The Federal Food, Drug, and 
     Cosmetic Act is amended--
       (1) in section 301(aa) (21 U.S.C. 331(aa)), by striking 
     ``covered product in violation of section 804'' and inserting 
     ``prescription drug in violation of section 804''; and
       (2) in section 303(a)(6) (21 U.S.C. 333(a)(6), by striking 
     ``covered product pursuant to section 804(a)'' and inserting 
     ``prescription drug under section 804(b)''.
                                  ____

  SA 4301. Mr. COCHRAN (for himself, Mr. Breaux, Mr. Roberts, Mr. 
Santorum, Mr. Nickles, and Mr. Hutchinson) proposed an amendment to 
amendment SA 4299 proposed by Mr. Reid (for Mr. Dorgan (for himself, 
Mr. Wellstone, Mr. Jeffords, Ms. Stabenow, Ms. Collins, Mr. Levin, Mr. 
Johnson, Mr. Miller, Mr. Durbin, Mr. Feingold, and Mr. Harkin)) to the 
bill (S. 812) to amend the Federal Food, Drug, and Cosmetic Act to 
provide greater access to affordable pharmaceuticals; as follows:

       On page 15, line 17, strike ``section.''.'' and insert 
     ``section.'' and insert the following new subsection:
       ``(e) Conditions.--This section shall become effective only 
     if the Secretary of Health and Human Services certifies to 
     the Congress that the implementation of this section will--
       ``(A) pose no additional risk to the public's health and 
     safety, and
       ``(B) result in a significant reduction in the cost of 
     covered products to the American consumer.''.''
                                  ____

  SA 4302. Mr. THOMAS (for himself and Mr. Roberts) submitted an 
amendment intended to be proposed to amendment SA 4299 proposed by Mr. 
Reid (for Mr. Dorgan (for himself, Mr. Wellstone, Mr. Jeffords, Ms. 
Stabenow, Ms. Collins, Mr. Levin, Mr. Johnson, Mr. Miller, Mr. Durbin, 
Mr. Feingold, and Mr. Harkin)) to the bill (S. 812), to amend the 
Federal Food, Drug, and Cosmetic Act to provide greater access to 
affordable pharmaceuticals; which was ordered to lie on the table, as 
follows:

       Strike subsection (h) of section 804 of the Federal Food, 
     Drug, and Cosmetic Act (as added by the amendment) and insert 
     the following:
       ``(h) Labeling.--
       ``(1) Approved labeling.--The manufacturer of a 
     prescription drug shall provide an importer written 
     authorization for the importer to use, at no cost, the 
     approved labeling for the prescription drug.
       ``(2) Disclaimer.--The importer of any prescription drug 
     under this section shall provide a labeling statement 
     prominently displayed and in bold face type as follows:

     ``THIS DRUG HAS BEEN IMPORTED FROM CANADA.

     
                                  ____
  SA 4303. Mrs. FEINSTEIN submitted an amendment intended to be 
proposed by her to the bill S. 812, to amend the Federal Food, Drug, 
and Cosmetic Act to provide greater access to affordable 
pharmaceuticals, which was ordered to lie on the table; as follows:

       At the end, add the following:

     SEC. __. ELIGIBILITY OF CHILDREN ENROLLED IN THE STATE 
                   CHILDREN'S HEALTH INSURANCE PROGRAM FOR THE 
                   PEDIATRIC VACCINE DISTRIBUTION PROGRAM.

       (a) In General.--Section 1928(b)(2)(B)(ii)(I) of the Social 
     Security Act (42 U.S.C. 1396s(b)(2)(B)(ii)(I)) is amended by 
     inserting ``(other than a State child health plan under title 
     XXI)'' after ``policy or plan''.
       (b) Effective Date.--The amendment made by subsection (a) 
     applies with respect to vaccines administered on or after the 
     date of the enactment of this Act.
                                  ____

  SA 4304. Mr. SMITH of New Hampshire (for himself, Mr. Allard, Mr. 
Grassley, Mr. Hatch, Mr. Burns, Mr. Craig, Mr. Crapo, and Mr. Santorum) 
submitted an amendment intended to be proposed by him to the bill S. 
812, to amend the Federal Food, Drug, and Cosmetic Act to provide 
greater access to affordable pharmaceuticals; which was ordered to lie 
on the table; as follows:
       At the appropriate place, insert the following:

     SEC. __. MEDICARE PAYMENT FOR OUTPATIENT PRESCRIPTION DRUGS 
                   UNDER THE RX OPTION.

       (a) In General.--Title XVIII of the Social Security Act (42 
     U.S.C. 1395 et seq.) is amended by redesignating part D as 
     part E and by inserting after part C the following new part:

        ``Part E--Voluntary Medicare Prescription Drug Coverage


                   ``Medicare Prescription Drug Plan

       ``Sec. 1860AA. (a) In General.--Each Medicare Prescription 
     Drug Plan eligible individual may elect coverage (beginning 
     on

[[Page 13273]]

     January 1, 2003) under this part in lieu of any other 
     prescription drug coverage program under this title by 
     enrolling in the Rx Option in order to receive coverage for 
     outpatient prescription drugs as described in section 1860BB 
     and to pay a combined deductible under section 1860CC.
       ``(b) Medicare Prescription Drug Plan Eligible Individual 
     Defined.--In this part, the term `Medicare Prescription Drug 
     Plan eligible individual' means an individual who is--
       ``(1) eligible for benefits under part A and enrolled under 
     part B;
       ``(2) not enrolled in a Medicare+Choice plan under part C; 
     and
       ``(3) not eligible for medical assistance for outpatient 
     prescription drugs under title XIX.


                              ``rx option

       ``Sec. 1860BB. (a) Enrollment in the Rx Option.--
       ``(1) In general.--Except as provided in paragraph (2), the 
     Secretary shall establish a process for the enrollment of 
     Medicare Prescription Drug Plan eligible individuals under 
     the Rx Option that is based upon the process for enrollment 
     in Medicare+Choice plans under part C of this title.
       ``(2) Exceptions.--
       ``(A) 2-year obligation.--Except as provided in 
     subparagraph (B), a Medicare Prescription Drug Plan eligible 
     individual who elects the Rx Option shall be subject to the 
     provisions of this part for a minimum period of 2 years, 
     beginning with the first full month during which the 
     individual is eligible for benefits under the Rx Option.
       ``(B) Free look period.--An individual who elects the Rx 
     Option may disenroll from such Option no later than the last 
     day of the first full month following the month in which such 
     election was made.
       ``(3) Enrollment in medicare supplemental policies.--An 
     individual enrolled in the Rx Option may be enrolled only in 
     a medicare supplemental policy subject to the special rules 
     described in section 1882(v).
       ``(b) Outpatient Prescription Drug Benefits.--
       ``(1) In general.--Beginning in 2002, under the Rx Option, 
     after the enrollee has met the combined deductible under 
     section 1860C, the Secretary shall provide a benefit for 
     outpatient prescription drugs through private entities under 
     section 1860D equal to 50 percent of the lesser of--
       ``(A) the cost of outpatient prescription drugs for such 
     year; or
       ``(B) $5000.
       ``(2) Cost-of-living adjustment.--In the case of any 
     calendar year beginning after 2002, the dollar amount in 
     paragraph (1)(B) shall be increased by an amount equal to--
       ``(A) such dollar amount; multiplied by
       ``(B) the percentage (if any) by which--
       ``(i) the prescription drug component of the Consumer Price 
     Index for all urban consumers (all items city average) for 
     the 12-month period ending with August of the preceding year; 
     exceeds
       ``(ii) such prescription drug component of the Consumer 
     Price Index for the 12-month period ending with August 2001.
       ``(3) Rounding.--If any increase determined under paragraph 
     (2) is not a multiple of $1, such increase shall be rounded 
     to the nearest multiple of $1.


                         ``combined deductible

       ``Sec. 1860CC. (a) In General.--Notwithstanding any 
     provision of this title and beginning in 2002, a beneficiary 
     electing the Rx Option shall be subject to a combined 
     deductible that shall apply in lieu of the deductibles 
     applied under sections 1813(a)(1) and 1833(b).
       ``(b) Amount.--
       ``(1) In general.--For purposes of subsection (a), the 
     combined deductible is equal to $675.
       ``(2) Cost-of-living adjustment.--In the case of any 
     calendar year after 2002, the dollar amount in paragraph (1) 
     shall be increased by an amount equal to--
       ``(A) such dollar amount; multiplied by
       ``(B) the percentage (if any) by which--
       ``(i) the medical component of the Consumer Price Index for 
     all urban consumers (all items city average) for the 12-month 
     period ending with August of the preceding year; exceeds
       ``(ii) such medical component of the Consumer Price Index 
     for the 12-month period ending with August 2001.
       ``(3) Rounding.--If any increase determined under paragraph 
     (2) is not a multiple of $1, such increase shall be rounded 
     to the nearest multiple of $1.
       ``(c) Application.--In applying the combined deductible 
     described in subsection (a) such deductible shall apply to 
     each expense incurred on a calendar year basis for each item 
     or service covered under this title, and each expense paid on 
     a calendar year basis for such an item or service shall be 
     credited against such deductible.


      ``partnerships with private entities to offer the rx option

       ``Sec. 1860DD. (a) Partnerships.--
       ``(1) In general.--The Secretary shall contract with 
     private entities for the provision of outpatient prescription 
     drug benefits under the Rx Option.
       ``(2) Private entities.--The private entities described in 
     paragraph (1) shall include insurers (including issuers of 
     medicare supplemental policies under section 1882), 
     pharmaceutical benefit managers, chain pharmacies, groups of 
     independent pharmacies, and other private entities that the 
     Secretary determines are appropriate.
       ``(3) Areas.--The Secretary may award a contract to a 
     private entity under this section on a local, regional, or 
     national basis.
       ``(4) Drug benefits only through private entities.--
     Outpatient prescription drug benefits under the Rx Option 
     shall be offered only through a contract with a private 
     entity under this section.
       ``(b) Secretary Required To Contract With Any Willing 
     Qualified Private Entity.--The Secretary may not exclude a 
     private entity from receiving a contract to provide 
     outpatient prescription drug benefits under the Rx Option if 
     the private entity meets all of the requirements established 
     by the Secretary for providing such benefits.


                ``eligibility for catastrophic coverage

       ``Sec. 1860EE. Noting in this part shall be construed to 
     prohibit an individual who elects coverage under the Rx 
     Option from obtaining catastrophic coverage under any other 
     program under this title.''.
       (b) Conforming Medigap Changes.--Section 1882 of the Social 
     Security Act (42 U.S.C. 1395ss) is amended by adding at the 
     end the following new subsection:
       ``(v) Special Rules for Medicare Prescription Drug Plan 
     Enrollees.--
       ``(1) Revision of benefit packages.--
       ``(A) In general.--Notwithstanding subsection (p), the 
     benefit packages established under such subsection (including 
     the 2 plans described in paragraph (11)(A) of such 
     subsection) shall be revised (in the manner described in 
     subsection (p)(1)(E)) so that each of the benefit packages 
     classified as `A' through `J' remain exactly the same, except 
     that each benefit package shall include special rules that 
     apply only to individuals enrolled in the Rx Option under 
     section 1860B as follows:
       ``(i) Combined deductible.--Each benefit package shall 
     require the beneficiary of the policy to pay annual out-of-
     pocket expenses (other than premiums) in an amount equal to 
     the amount of the combined deductible under section 1860C(b) 
     before the policy begins payment of any benefits.
       ``(ii) Prescription drug coverage.--In the case of a 
     benefit package classified as `H', `I', and `J', such policy 
     may not provide coverage for outpatient prescription drugs 
     that duplicates the coverage for outpatient prescription 
     drugs provided under the Rx Option under section 1860B(b).
       ``(B) Adjusted premium.--In the case of an individual 
     enrolled in the Rx Option, the premium for the policy in 
     which the individual is enrolled may be appropriately 
     adjusted to reflect the special rules applicable to such 
     individual under subparagraph (A).
       ``(2) Renewability and continuity of coverage.--The 
     revisions of benefit packages under paragraph (1) shall not 
     affect--
       ``(A) the renewal of medicare supplemental policies under 
     this section that are in existence on the effective date of 
     such revisions; or
       ``(B) the continuity of coverage under such policies.''.
  SA 4305. Mr. REID (for Ms. Stabenow) proposed an amendment to the 
bill S. 812, to amend the Federal Food, Drug, and Cosmetic Act to 
provide greater access to affordable pharmaceuticals; as follows:

       At the end, add the following:

     SEC. __. CLARIFICATION OF STATE AUTHORITY RELATING TO 
                   MEDICAID DRUG REBATE AGREEMENTS.

       Section 1927 of the Social Security Act (42 U.S.C. 1396r-8) 
     is amended by adding at the end the following:
       ``(l) Rule of Construction.--Nothing in this section shall 
     be construed as prohibiting a State from--
       ``(1) directly entering into rebate agreements that are 
     similar to a rebate agreement described in subsection (b) 
     with a manufacturer for purposes of ensuring the 
     affordability of outpatient prescription drugs in order to 
     provide access to such drugs by residents of a State who are 
     not otherwise eligible for medical assistance under this 
     title; or
       ``(2) making prior authorization (that satisfies the 
     requirements of subsection (d) and that does not violate any 
     requirements of this title that are designed to ensure access 
     to medically necessary prescribed drugs for individuals 
     enrolled in the State program under this title) a condition 
     of not participating in such a similar rebate agreement.''.
                                  ____

  SA 4306. Mrs. FEINSTEIN (for herself, Mrs. Hutchison, Mr. Thurmond, 
Mr. Domenici, Mr. Bingaman, Mr. Biden, Mr. Carper, Mr. Wyden, Mr. Smith 
of Oregon, Mr. Frist, and Mr. Thompson) proposed an amendment to the 
bill H.R. 5011, making appropriations for military construction, family 
housing, and base realignment and closure for the Department of Defense 
for the fiscal year ending September 30, 2003, and for other purposes; 
as follows:

       Viz: At the appropriate place, insert the following:

[[Page 13274]]

       Sec.  Of the amount appropriated in this Act under the 
     heading ``Military Construction, Army'', $8,000,000 may be 
     provided for a parking garage at Walter Reed Army Medical 
     Center, District of Columbia.
       Sec.  Of the amount appropriated in this Act under the 
     heading ``Military Construction, Army'', $3,000,000 may be 
     provided for an Anechoic Chamber at White Sands Missile 
     Range, New Mexico.
       Sec.  Of the amount appropriated in this Act under the 
     heading ``Military Construction, Air Force'', $7,500,000 may 
     be provided for a control tower at Dover Air Force Base, 
     Delaware.
       Sec.  Of the amount appropriated in this Act under the 
     heading ``Military Construction, Army National Guard'', 
     $9,000,000 may be provided for a Joint Readiness Center at 
     Eugene, Oregon.
       Sec.  Of the amount appropriated in this Act under the 
     heading ``Military Construction, Air National Guard'', 
     $8,400,000 may be provided for a composite Maintenance 
     Complex, Phase II in Nashville, Tennessee.

                          ____________________