Dec. 15, 2009(Key vote)
Title: Authorizing Importation of Prescription Drugs
Vote Smart's Synopsis:
Vote to adopt an amendment to S Amdt 2786 to HR 3590 that allows for the importation of prescription pharmaceuticals from registered exporters.
- Authorizes pharmacies, registered wholesale importers, and individuals who purchase prescription drugs for personal use from a registered exporter to import such prescription drugs (Sec. 10004).
- Repeals existing restrictions established by the Federal Food, Drug and Cosmetic Act on the importation of prescription drugs from Canada (Sec. 10003).
- Limits the countries from which prescription drugs can be imported to the following (Sec. 10004):
- New Zealand;
- Members of the European Union, unless:
- The countries Annex to the Treaty of Accession to the European Union includes a measure to regulate pharmaceutical products that have not expired; or
- The Secretary of Health and Human Services determines that the country has not met specific regulatory requirements listed below;
- Any country that the Secretary has determines the following requirements are met:
- The country has regulations to require the review of the safety and effectiveness of the drugs by a government entity, and only approves drugs that are determined to be safe and effective;
- The country has regulations that require the methods and facilities for the manufacture, processing, and packing of drugs to adequately preserve their identity, quality, purity, and strength;
- The country has regulations that require the reporting of adverse reactions to drugs and procedures to withdrawal approval or remove drugs;
- The country has regulations to require the labeling and promotion of drugs to be in accordance with the approval of the drug;
- The valid marketing system in the country is equivalent to the systems in the aforementioned approved countries; and
- The importation of drugs to the U.S. from the country will not "adversely affect the public health."
- Prohibits drug manufacturers from engaging in the following activities (Sec. 10004):
- Arbitrarily charging higher prices for prescription drugs, either directly or indirectly, to any importer, exporter, or individual;
- Failing to submit notices required by this Act, or making fraudulent statements or providing false information about prescription drugs;
- Distributing prescription drugs in the U.S. that are different (e.g., active ingredient, dosage, strength, etc.) from a drug distributed under the same label in another country, unless:
- The difference is required by the country of origin;
- The difference is necessary to improve the safety or effectiveness of the drug, as determined by the Secretary;
- The distributor notified the Secretary that the drug is not different from a drug for distribution in permitted countries whose combined population represents at least 50 percent of the total population of all permitted countries; or
- The differences is not caused for the purpose of restricting importation to the United States;
- Refusing to allow inspections;
- Failing to conform to good manufacturing practices;
- Procuring a licensing agreement or other agreement for a drug that fails to comply with all requirements;
- Entering into a contract or engaging in any other action that restricts, prohibits, or delays the importation of a drug; and
- Engaging in any other action that discriminates against individuals, as determined by the Federal Trade Commission.
- Authorizes the Secretary of Health and Human Services to place first and second year limitations on the number of registered importers and exporters of prescription drugs (Sec. 10004).
- Requires the Secretary of Health and Human Services to carry out activities that educate the public on the following topics (Sec. 10004):
- The availability of imported prescription drugs for personal use, including information on which exporters are registered with the Food and Drug Administration (FDA) and a toll free number for consumers to call;
- Information that imported drugs sold by an exporter not registered with the FDA will be seized and destroyed by the U.S. Customs Service, and that such drugs could be "counterfeit, unapproved, unsafe, or ineffective";
- Which importers and exporters have had their registration suspended or revoked; and
- The availability of imported prescription through domestic wholesalers or retail pharmacies.
- Prohibits the sale and shipment of prescription drugs through Internet communications where the purchaser and the dispenser do not have an "appropriate medical relationship", unless such sale or shipment is made via a hospital telemedicine practice or a group practice with 100 or more physicians with a Medicare provider agreement (Sec. 10007).
- Prohibits the sale of prescription drugs from unregistered pharmacists from other countries, including requests for purchases by mail, fax, phone, email or other Internet communication (Sec. 10008).
NOTE: THIS VOTE IS SUBJECT TO A SPECIAL ORDER REQUIRING A 3/5 MAJORITY FOR PASSAGE.