Food, Drug, and Cosmetic Act

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The Federal Food, Drug, and Cosmetic Act (FD&C or FDCA) was passed in 1938 to give the Food and Drug Administration (FDA) authority over foods, drugs and cosmetics in the United States.[1] It has been amended many times to expand this authority, most notably in the Food and Drug Administration Modernization Act (FDAMA) of 1997.

The FD&C requires a drug company to specify, in its applications for approval of a new prescription drug, the intended uses of the new drug. If the drug is approved by the FDA, the company may not market or promote the drug for so-called "off-label" uses that were not specified in the application and approved by the FDA. This is true even though "off-label" uses of prescription drugs to treat medical conditions are legal. Former FDA Commissioner Jane E. Henney noted one study finding that 21% of drugs listed in a data set were being prescribed for off-label use.[2]

The Washington Legal Foundation sued to prevent the FDA from enforcing limitations on off-label marketing, citing the First Amendment right to free speech. In 1998, a federal district court barred the FDA from taking any official action that unduly restricted commercial speech.

The federal district court later limited the injunction to off-label uses of drugs. In 2000, the FDA won a bit of a victory when the federal appeals court overturned the injunction based on the government's position that "neither the FDAMA nor the CME [continuing medical education] Guidance independently authorizes the FDA to prohibit or to sanction speech." But lacking power to prohibit or sanction speech related to off-label marketing, the FDA can only respond by bringing a misbranding enforcement action against the manufacturer.

The court also set limits on FDA regulation of commercial speech related to advertising and promotion of compounded drugs and health claims of dietary supplements. The FDA sought public comment on how to regulate this area in the future while still respecting free speech.

  1. Major sections of the FDCA include 21 U.S.C. §§ 321, 331, 351, 352, 353a, 355, 360, 374