Waxman: Planned Guidance Could Open Loophole for Off-Label Promotion

Rep. Henry Waxman (D-Calif.) is urging the FDA not to release a guidance allowing drug and medical device companies to use journal articles to promote off-label use of their products.

Last week, Waxman released a copy of the draft guidance, which has not yet been issued by the agency, and sent a letter to the FDA requesting that it not continue work on the document until it provides further information to the House Oversight and Government Reform Committee.

According to the guidance, if a manufacturer were to follow the agency’s recommendations and there was no unlawful promotion of the manufacturer’s product, the FDA would view the distribution of medical and scientific information as evidence of manufacturer intent that the product can be used for an unapproved use.

Waxman said a fundamental tenet of drug and device law is that a manufacturer cannot market a drug or device for a therapeutic use without FDA approval. The draft guidance “would carve a large loophole in the law,” allowing manufacturers to promote off-label uses of their products by passing out journal articles about those uses to physicians, he said.

The FDA has traditionally interpreted the Federal Food, Drug and Cosmetic Act as giving it authority to consider dissemination of such articles as evidence a company was engaged in illegal marketing, he said.

Waxman’s letter can be seen at oversight.house.gov/documents/20071130102744.pdf, and a copy of the draft guidance can be found at oversight.house.gov/documents/20071130103225.pdf.