ERIC Number: ED238063
Record Type: Non-Journal
Publication Date: 1983-Nov
Reference Count: N/A
Drug Advertising and the FDA.
With increases in consumer focused advertising for prescription drugs, the Federal Drug Administration has renewed efforts to protect the public from false advertising. In 1982, it charged that the press kits Eli Lilly and Company distributed to reporters on its new antiarthritis drug, Oraflex, misrepresented the product. It recommended that Lilly both remove its claim that the drug halted or reversed arthritis and add a list of possible serious side effects from the drug, such as liver damage. Lilly, however, failed to respond. When criticized by a House of Representatives subcommittee for its slowness in acting, the FDA responded that it was prevented by the First Amendment from taking serious action against Lilly until the press release was proven to be misleading the public. The FDA's clinical investigations office then recommended prosecuting Lilly for failing to report adverse reactions on four drugs, including Oraflex. Although withdrawing the drug from the market, the company continued to maintain that its press kit was accurate and balanced. The FDA is also having difficulty regulating the promotion of drugs awaiting FDA approval. Since preclearance of ads is not required, it is unclear how to remedy ads found to be misleading. The FDA continues, however, to study and to try to control direct-to-consumer drug advertiseme (MM)
Publication Type: Information Analyses
Education Level: N/A
Audience: Researchers; Community
Authoring Institution: Freedom of Information Center, Columbia, MO.