FDA tightens rules on advertising

BMJ 1997; 315 doi: (Published 23 August 1997) Cite this as: BMJ 1997;315:445
  1. Deborah Josefson
  1. San Francisco

    Pharmaceutical companies in the United States must provide more information when advertising directly to the public, the Food and Drug Administration (FDA) has ruled, after mounting concern that a lot of promotional material is confusing. Television and radio advertisements are particularly targeted under the new rules, which come into effect immediately.

    The pharmaceutical industry in the United States spends $600m (£375m) a year promoting its products to the general public. A survey by the Washington based advertising firm Scott and Lieb found that 57% of doctors said that patients often come in holding a drug advertisement in their hand or referring to a drug manufacturer's promotional material. Dr Wendy Schwartz, a family doctor at Georgetown University in Washington, DC, said that on average two patients a day appear in her surgery requesting an advertised drug by name.

    The Federal Food, Drug and Cosmetic Act of 1994 required advertisements for prescription drugs that made medicinal claims to contain a “brief summary” and a “major statement” in which the drug's indications, contraindications, risks, and side effects are clearly stated. These conditions were easily met by print advertisements, but because of time, space, and monetary constraints, television and radio advertisements rarely included this information. Consequently, the FDA exempted them from this requirement so long as their communications did not make any therapeutic claims. As a result, most drug advertisements that are broadcast only mention the drug's name and obliquely allude to its therapeutic indication, urging consumers to ask their doctor about the drug.

    The new rules will allow manufacturers to include therapeutic claims so long as adequate provisions are made to disseminate information about the drug's side effects–for example, by supplying freephone numbers or an internet address.

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