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Group: Members
Posts: 1167
Member No.: 58
Joined: 20-August 04
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| QUOTE | 7/26/2004 for the Committee on Judiciary and Government Affairs
Mr. Dallas, for himself, and Mr. MacGyver, submit:
A BILL
to authorize the Secretary of Health and Human Services to promulgate regulations for the reimportation of prescription drugs, and for other purposes.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE AND PURPOSE
(a) This Act may be cited as the "Prescription for Change Act of 2004"
(b) The purpose of this Act is to authorize the Secretary of Health and Human Services to promulgate regulations for the reimportation of prescription drugs, as well as to permit the Secretary to negotiate the bulk price of prescription drugs to lower the price paid by the federal government and all Americans for prescription drugs.
SEC. 2. 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) CANADIAN PHARMACIST- The term `Canadian pharmacist' means a person licensed in Canada to practice pharmacy, including the dispensing and selling of prescription drugs .
`(2) CANADIAN WHOLESALER- The term `Canadian wholesaler' means a person licensed in Canada to distribute within Canada prescription drugs that have been approved by Health Canada .
`(3) CANADIAN EXPORTER- The term `Canadian exporter' means a Canadian pharmacist or Canadian wholesaler.
`(4) IMPORTER- The term `importer' means a pharmacist or wholesaler.
`(5) PHARMACIST- The term `pharmacist' means a person licensed by a State to practice pharmacy, including the dispensing and selling of prescription drugs .
`(6) 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));
`� an infused drug (including a peritoneal dialysis solution);
`(D) an intravenously injected drug; or
`(E) a drug that is inhaled during surgery.
`(7) 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.
`(8) 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- No later than 18 months after the date of enactment of this section, 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.
`� LIMITATION- The regulations under subsection (b) shall--
`(1) require that a Canadian exporter--
`(A) register with the Secretary the name and place of business of the Canadian exporter (and including the place of business of each warehouse and establishment of the Canadian exporter);
`(B) export only prescription drugs that have been approved by Health Canada and meet all requirements of Canadian law;
`� permit inspections by the Secretary (including inspections of all records, including financial records) of each warehouse and establishment of the Canadian exporter; and
`(D) pay an inspection fee to the Secretary on a semiannual basis not to exceed 5 percent of the total price of prescription drugs exported by the Canadian exporter to the United States under the regulations (which fees the Secretary shall use solely to inspect the warehouses and establishments of Canadian exporters and to monitor imports of prescription drugs at ports of entry);
`(2) require that each prescription drug imported under the regulations be imported directly from a Canadian exporter through a limited number of ports of entry (at which the Secretary shall monitor such imports);
`(3) 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;
`(4) require that an importer of a prescription drug under the regulations comply with subsections (d)(1) and (e); and
`(5) 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.
`� 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) SUSPENSION OF IMPORTATION- The Secretary shall require that importations of a specific prescription drug or importations by a specific importer or from a specific Canadian exporter under subsection (b) be immediately suspended on discovery of a pattern of importation
of that specific prescription drug or by that specific importer or Canadian exporter of drugs that are counterfeit or in violation of any requirement under this section, 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).
`(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, wholesaler, or Canadian exporter 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, wholesaler, or Canadian exporter 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, wholesalers, or Canadian exporters 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, wholesalers, or Canadian exporters 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;
`� is imported from Canada , from a Canadian exporter 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)'.
SEC. 3 NEGOTIATING FAIR PRICES FOR MEDICARE PRESCRIPTION DRUGS .
Section 1860D-11 of the Social Security Act, as added by section 101(a) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, is amended by striking subsection (i) (relating to noninterference) and by inserting the following:
`(i) AUTHORITY TO NEGOTIATE PRICES WITH MANUFACTURERS- In order to ensure that beneficiaries enrolled under prescription drug plans and MA-PD plans pay the lowest possible price, the Secretary shall have authority similar to that of other Federal entities that purchase prescription drugs in bulk to negotiate contracts with manufacturers of covered part D drugs , consistent with the requirements and in furtherance of the goals of providing quality care and containing costs under this part.'.
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VOTE: (HR 1.211) Prescription for Change Act of, Ending Dec 3
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