On the recordOctober 18, 2000
with sections 745 and 746 of this bill, the Congress intends to facilitate access for Americans to reimport U.S.-made prescription medicines, as long as it does not lower the safety standards that previous Congresses and Administrations have carefully developed in consumer, health and safety protection legislation over the years. Under these provisions, Americans are allowed access to U.S. products sold overseas at lower prices provided that those medicines, when reimported, are demonstrated to be safe and effective. At the time the Senate considered this appropriations bill, the Senate adopted an additional safeguard to protect consumer health and safety. By a vote of 96 to 0, the Senate agreed to an amendment which Senator Kohl and I offered to the amendment of Senator Jeffords to include the Medicine Equity and Drug Safety Act of 2000 on this bill. That amendment is retained in this conference report, and requires the Secretary of Health and Human Services to make two determinations before the changes to the Federal Food, Drug and Cosmetic Act, FFDCA, in section 745(c) can be implemented. The Secretary is required to demonstrate to the Congress that implementation will: (1) pose no additional 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.
Source
govinfo.gov




