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The risky business of off-label use: off-label use of drugs and devices is an accepted part of modern medical practice. When harm results, lawyers must navigate the maze of regulatory and case law to hold drug companies accountable.

Article Excerpt
Because the FDA requires that prescription drugs and medical devices undergo lengthy, costly review and testing before their approval and marketing, American consumers trust the agency to ensure that these products are safe and effective. But most people do not realize that many drugs and medical devices are prescribed for uses that the manufacturer did not intend and that have not been tested for safety and efficacy.

Indeed, doctors are free to prescribe FDA-approved medications and devices in any way they deem medically appropriate, without regulatory oversight. (1) At least one court has acknowledged that off-label use is "subject to asymmetrical--if not necessarily inconsistent--regulatory treatment." (2)

Lawsuits brought by patients injured as a result of off-label use have raised complex issues that the courts are working to resolve. Recent changes in statutes governing the FDA and an ever-growing body of federal and state case law make representing injured clients challenging. But the effort is worthwhile: Litigation over off-label use has the potential to improve drug safety for all health care consumers.

Off-label use is a key component of mainstream medical practice and a recognized exception to FDA oversight. (3) Many off-label uses are recommended by research institutions, professional organizations, and standard pharmaceutical reference books. They are especially common in treating AIDS, cancer, and rare diseases. The Supreme Court has said that off-label use "is an accepted and necessary corollary of the FDA's mission to regulate [drugs and medical devices] in this area without directly interfering with the practice of medicine." (4)

FDA policy states that "once a [pharmaceutical] product has been approved for marketing, a physician may prescribe it for uses or in treatment regimens of patient populations that are not included in approved labeling." (5) This policy, known as the practice-of-medicine exemption, reflects the history of the 1938 Food, Drug, and Cosmetic Act (FDCA). (6) The FDCA was intended to regulate the manufacture of pharmaceutical products, rather than the conduct of doctors in prescribing them. Similarly, the 1997 Food and Drug Administration Modernization Act (FDAMA), amending the FDCA, includes specific protection for prescriber choice. (7)

At the same time, the FDCA prohibits drug and device manufacturers from marketing or promoting a product for a use that the FDA has not approved. (8) If its labeling includes information about unapproved uses, the drug has been "misbranded." (9)

The FDAMA says that if a manufacturer intends to promote a drug for new uses, it must resubmit the drug for FDA testing and approval. (10) However, the act's so-called Mack-Frist provision, [section] 401, allows manufacturers or...

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