1.  Statute summary: The Food, Drug and Cosmetics Act provides for an elaborate system of testing drugs before the Food and Drug Administration can approve them for sale to the public.
 

a. In response to the public outcry for quicker approval of drugs to combat AIDS, in 1993, Congress passes an AIDS drug law that includes a rulemaking provision that provides that "the FDA may, by regulation, adopt procedures for expedited approval of AIDS drugs."

b. In accordance with Section 553 of the APA (informal rulemaking provisions), the FDA proposes rules under the AIDS drug law that would streamline the process for approval of AIDS drugs.

c. Before the FDA's rules are finalized, the manufacturers of the AIDS drugs that are currently approved by the FDA lobby Congress, and, in 1994, Congress adopts several amendments to the AIDS drug law.  In one of the amendments, Congress changes the rulemaking provision to provide that "After opportunity for a hearing, the FDA may adopt procedures for expedited approval of AIDS drugs that meet the following requirements: [the statute lists several requirements]"

d. After the amendments to the AIDS drug law are enacted, the FDA begins the informal rulemaking procedures again, and, in full compliance with Section 553 of the APA, the FDA promulgates a final rule that provides for a streamlined approval process for AIDS drugs.

e. Question to think about: Representing an interest group that opposes expedited approval of drugs by the FDA, what challenges could you make to the approval process adopted by FDA? What counterarguments might the manufacturer of an experimental AIDS drug make to support the approval process?

a. Assume that the AIDS drug law that Congress initially passed in 1993 gave the FDA the authority to approve new AIDS drugs on an expedited basis and did not require the agency to promulgate regulations to create an expedited approval process. It merely provided that the agency could approve the drugs on an expedited basis.

b. Prior to amendment of the statute in 1994, the FDA established an informal adjudicatory process for approving AIDS drugs. Under the process, the applicant and anyone who opposed the application could submit written testimony in support of or against the application.

c. The manufacturers of AIDS drugs currently on the market lobbied Congress to amend the AIDS drugs law. One of the changes that Congress made in 1994 was an amendment to the AIDS drug approval language, so that it now states that "the FDA may, after opportunity for a public hearing, approve the following categories of AIDS drugs on an expedited basis:" (the statute then lists several categories of AIDS drugs).

d. After the AIDS drug law was amended, the FDA established a new adjudicatory process for approving AIDS drugs that includes some, but not all, of the procedures in Sections 554, 556 and 557 of the APA.

e. Questions to think about: What challenges could you make to the approval process used by FDA? What counterarguments could you make?