[Ip-health] House provision in agriculture bill which prohibits the FDA from blocking parallel trade in pharmaceuticals

[Mike Palmedo]

Here's the provision in this year's House agricultural appropriations
bill prohibiting the FDA from using any funds to block reimportation.
It was passed by the House on August 2. The Senate version of the
legislation, which does not include this provision, was introduced on
July 24 and hasn't moved forward:

SEC. 726. None of the funds appropriated or otherwise made available by
this Act for the Food and Drug Administration may be used under section
801 of the Federal Food, Drug, and Cosmetic Act to prevent an individual
not in the business of importing a prescription drug within the meaning
of section 801(g) of such Act, wholesalers, or pharmacists from
importing a prescription drug (as defined in section 804(a)(3) of such
Act) which complies with sections 501, 502, and 505 of such Act.

This section is on page 71 of the bill, the full text of which is here:
http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_bills&docid=f:h3161eh.txt.pdf

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What do all of the sections referred to mean?

801 sets rules for imports and exports.

801(g) specifies circumstances under which the FDA can warn individuals
against importing drugs for personal use

804(a)(3) defines "prescription drug"

501 bans drugs that have been adulterated

501 bans drugs which have been mislabeled

505 governs FDA approval of new and generic drugs.


--
Mike Palmedo
Research Coordinator
Program on Information Justice and Intellectual Property
American University, Washington College of Law
4910 Massachutsetts Ave., NW Washington, DC 20016
T - 202-274-4442 | F 202-274-0659
mpalmedo@wcl.american.edu