Amendment to HR 4461, the appropriation bill for the Food and Drug Administration (FDA), Agriculture, and Rural Development
Senator Jim Jeffords from Vermont introduced an amendment, based on SB2520, which he originally introduced into the Senate.
The Senator from Vermont [Mr. Jeffords], for himself, Mr. Wellstone, Mr. Dorgan, Ms. Snowe, Mr. Gorton, Mr. Johnson, Mr. Levin, and Mr. Bryan, proposes an amendment numbered 3925.
(a) Short Title: This section may be cited as the `Medicine Equity and Drug Safety Act of 2000'. (b) Findings: Congress makes the following findings:
(1) The cost of prescription drugs for Americans continues to rise at an alarming rate.
(2) Millions of Americans, including medicare beneficiaries on fixed incomes, face a daily choice between purchasing life-sustaining prescription drugs, or paying for other necessities, such as food and housing.
(3) Many life-saving prescription drugs are available in countries other than the United States at substantially lower prices, even though such drugs were developed and are approved for use by patients in the United States.
(4) Many Americans travel to other countries to purchase prescription drugs because the medicines that they need are unaffordable in the United States.
(5) Americans should be able to purchase medicines at prices that are comparable to prices for such medicines in other countries, but efforts to enable such purchases should not endanger the gold standard for safety and effectiveness that has been established and maintained in the United States. (c) Amendment: Chapter VIII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381 et seq.) is amended--
(1) in section 801(d)(1), by inserting `and section 804' after `paragraph (2)'; and
(2) by adding at the end the following:
`SEC. 804. IMPORTATION OF COVERED PRODUCTS. `(a) Regulations:
`(1) In general: Notwithstanding sections 301(d), 301(t), and 801(a), the Secretary, after consultation with the United States Trade Representative and the Commissioner of Customs, shall promulgate regulations permitting importation into the United States of covered products.
`(2) Limitation: Regulations promulgated under paragraph (1) shall--
`(A) require that safeguards are in place that provide a reasonable assurance to the Secretary that each covered product that is imported is safe and effective for its intended use;
`(B) require that the pharmacist or wholesaler importing a covered product complies with the provisions of subsection (b); and
`(C) contain such additional safeguards as the Secretary may specify in order to ensure the protection of the public health of patients in the United States.
`(3) Records: Regulations promulgated under paragraph (1) shall require that records regarding such importation described in subsection (b) be provided to and maintained by the Secretary for a period of time determined to be necessary by the Secretary. `(b) Importation:
`(1) In general: The Secretary shall promulgate regulations permitting a pharmacist or wholesaler to import into the United States a covered product.
`(2) Regulations: Regulations promulgated under paragraph (1) shall require such pharmacist or wholesaler to provide information and records to the Secretary, including--
`(A) the name and amount of the active ingredient of the product and description of the dosage form;
`(B) the date that such product is shipped and the quantity of such product that is shipped, points of origin and destination for such product, the price paid for such product, and the resale price for such product;
`(C) documentation from the foreignseller specifying the original source of the product and the amount of each lot of the product originally received;
`(D) the manufacturer's lot or control number of the product imported;
`(E) the name, address, and telephone number of the importer, including the professional license number of the importer, if the importer is a pharmacist or pharmaceutical wholesaler;
`(F) for a product that is--
`(i) coming from the first foreign recipient of the product who received such product from the manufacturer--
`(I) documentation demonstrating that such product came from such recipient and was received by such recipient from such manufacturer;
`(II) documentation of the amount of each lot of the product received by such recipient to demonstrate that the amount being imported into the United States is not more than the amount that was received by such recipient;
`(III) documentation that each lot of the initial imported shipment was statistically sampled and tested for authenticity and degradation by the importer or manufacturer of such product;
`(IV) documentation demonstrating that a statistically valid sample of all subsequent shipments from such recipient was tested at an appropriate United States laboratory for authenticity and degradation by the importer or manufacturer of such product; and
`(V) certification from the importer or manufacturer of such product that the product is approved for marketing in the United States and meets all labeling requirements under this Act; and
`(ii) not coming from the first foreign recipient of the product, documentation that each lot in all shipments offered for importation into the United States was statistically sampled and tested for authenticity and degradation by the importer or manufacturer of such product, and meets all labeling requirements under this Act;
`(G) laboratory records, including complete data derived from all tests necessary to assure that the product is in compliance with established specifications and standards; and
`(H) any other information that the Secretary determines is necessary to ensure the protection of the public health of patients in the United States. `(c) Testing: Testing referred to in subparagraphs (F) and (G) of subsection (b)(2) shall be done by the pharmacist or wholesaler importing such product, or the manufacturer of the product. If such tests are conducted by the pharmacist or wholesaler, information needed to authenticate the product being tested and confirm that the labeling of such product complies with labeling requirements under this Act shall be supplied by the manufacturer of such product to the pharmacist or wholesaler, and as a condition of maintaining approval by the Food and Drug Administration of the product, such information shall be kept in strict confidence and used only for purposes of testing under this Act. `(d) Study and Report:
`(1) Study: The Secretary shall conduct, or contract with an entity to conduct, a study on the imports permitted under this section, taking into consideration the information received under subsections (a) and (b). In conducting such study, the Secretary or entity shall--
`(A) evaluate importers' compliance with regulations, and the number of shipments, if any, permitted under this section that have been determined to be counterfeit, misbranded, or adulterated; and
`(B) consult with the United States Trade Representative and United States Patent and Trademark Office to evaluate the effect of importations permitted under this Act on trade and patent rights under Federal law.
`(2) Report: Not later than 5 years after the effective date of final regulations issued pursuant to this section, the Secretary shall prepare and submit to Congress a report containing the study described in paragraph (1). `(e) Construction: Nothing in this section shall be construed to limit the statutory, regulatory, or enforcement authority of the Secretary relating to importation of covered products, other than the importation described in subsections (a) and (b). `(f) Definitions: In this section:
`(1) Covered product: The term `covered product' means a prescription drug under section 503(b)(1) that meets the applicable requirements of section 505, and is approved by the Food and Drug Administration and manufactured in a facility identified in the approved application and is not adulterated under section 501 or misbranded under section 502.
`(2) Pharmacist: The term `pharmacist' means a person licensed by a State to practice pharmacy in the United States, including the dispensing and selling of prescription drugs.
`(3) Wholesaler: The term `wholesaler' means a person licensed as a wholesaler or distributor of prescription drugs in the United States.'.
Amendment SA 3925 agreed to in Senate by Yea-Nay Vote. 74 - 21.
Senator Thad Cochran of Mississippi added an amendment to the amendment
AMENDMENT NO. 3927 TO AMENDMENT NO. 3925 Mr. COCHRAN. Mr. President, I send a second-degree amendment to the desk.
The PRESIDING OFFICER. The clerk will report.
The legislative clerk read as follows:
The Senator from Mississippi [Mr. Cochran], for himself and Mr. Kohl, proposes an amendment numbered 3927.
At the end of the amendment insert the following:
`(g) This section shall become effective only if the Secretary of the Department of Health and Human Services certifies to the Congress that the implementation of this section will: (1) pose no risk to the public's health and safety; and (2) result in a significant reduction in the cost of covered products to the American consumer.'
Amendment SA 3927 agreed to in Senate by Yea-Nay Vote. 96 - 0.