Prescription drug advertisements presented in media such as television and radio must disclose the product’s major side-effects and contraindications, the FDA said in a final rule issued Monday.
The Food and Drug Administration augmented its existing authority on prescription drug advertisements through amending its regulations concerning direct-to-consumer ads.
The rule (RIN: 0910-AG27) requires advertisements to present a major statement—a disclosure on a prescription drug’s side-effects and contraindications in a clear, conspicuous, and neutral manner.
The clear, conspicuous, and neutral presentation of risk information in direct-to-consumer TV and radio ads, in addition to benefit information, “helps ensure that these ads convey a truthful and non-misleading net impression about the advertised drug and that consumers are better informed when they participate in healthcare decision making,” the agency said.
The FDA oversees advertising and other types of drug promotion under the federal Food, Drug, and Cosmetic Act. Pharmaceutical companies often promote their products to consumers and healthcare professionals through advertisements that appear on television, online, radio, or in magazines and newspapers.
“American consumers encounter ads for an enormous variety of goods and services, each ad seeking to attract their attention, pique their interest, and ultimately drive demand for the advertised product or service. But few ads provide information about products as important as prescription drugs. Prescription drugs are integral to healthcare, and decisions about their use can have critical effects on health and well-being,” the agency said in the final rule.
This final rule amends FDA’s prescription drug advertising regulations to be consistent with the current requirements of the FDCA, as amended by the by the Food and Drug Administration Amendments Act of 2007, that in human prescription drug ads presented directly to consumers in television or radio format and stating the name of the drug and its conditions of use, the major statement relating to side effects and contraindications shall be presented in a clear, conspicuous, and neutral manner.
The rule also lays out standards the agency will consider in determining whether the major statement is presented in the manner required by the 2007 law. Some standards include presenting information in language that is readily understandable by consumers, clear audio, and appropriately placed text in the advertisement.