FDA Revises Postmarketing Reporting Requirements for Discontinued Life-Supporting Drugs

Rockville, MD (Oct. 17)-Under a new US Food and Drug Administration revision, sole manufacturers of drugs considered life-supporting or life-sustaining or that prevent certain serious diseases or conditions will be required to notify FDA at least six months before discontinuing production of the product.

The revision applies to a proposed rule announced Nov. 7, 2000 to implement section 506(c) of the Federal Food, Drug, and Cosmetic Act. This rule applied to companies that are the sole manufacturers of drugs that meet the following criteria:

• The products are life-supporting, life-sustaining, or intended to prevent a debilitating disease or condition

• The products must have been approved under section 505(b) or (j) of the Act  [21 USC 355(b) or (j)]

• The products are not originally derived from human tissue and replaced by a recombinant product.

The amended, final rule modifies the reporting procedure for these drugs whether regulated by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). Manufacturers are required to send notifications of discontinuance or requests for reduction to the following offices:

• The drug shortage coordinator at the address of Director of CDER

• The Drug Registration and Listing Team, Division of Compliance Risk Management in CDER

• The director in the review division in CDER or CBER who is responsible for reviewing the application.

The proposed requirement to notify the Director of CBER was eliminated. Under certain circumstances, including economic hardship and public-health risks, the six-month notification period may be reduced.

FDA announced the amendment in the Oct. 18 issue of the Federal Register, and the final rule will take effect 60 days after this date.

The full document can be viewed here.