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Friday, November 30, 2007

Draft Guidance Would Create Drug Approval Loophole

An investigation by the House Oversight and Government Reform Committee shows that FDA is considering a new policy (which would take the form of a draft guidance document) that would allow drug companies to market unapproved use of pharmaceuticals by distributing journal articles. In a letter to FDA Commissioner Andrew von Eschenbach, Chairman Henry Waxman (D-CA) explains the problem:

A fundamental tenet of our drug and device laws 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 The draft guidance would carve a large loophole in the law and create a pathway by which drug and device manufacturers can promote unapproved (off-label) uses of their products without first obtaining FDA approval by passing out journal articles about the off-label use to physicians. Published reports of company funded studies can be biased in favor of the company's product. Allowing drug and device companies to freely disseminate these articles can result in doctors using questionable study results to guide their prescribing habits. In addition, allowing marketing through journal articles can reduce the incentive for drug and device companies to conduct the rigorous studies needed to win full FDA review and approval, leaving physicians and patients without definitive data on the benefits and risks of medical products.

Currently, this type of activity would be considered "illegal marketing," according to Waxman. Waxman believes the new policy would contravene the intent of the federal laws that govern the drug approval process: "The draft guidelines appear to be an effort by FDA to displace Congress and establish by administrative fiat a new system for use of journal articles that lacks the safeguards set by Congress."

The Committee is investigating the issue further, and has requested documents from FDA related to the draft guidance. In the interim, Waxman has requested FDA not move forward with the policy.