Healthy Skepticism Library item: 3055

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Joan SW.
Keeping prescription drug advertising honest: FDA's watchful eye
American Pharmacy 1980 May; 20:(5):40-44

Abstract:

Pharmaceutical manufacturers spend nearly $2 billion on advertising annually, regulated by a tiny division of the Food and Drug Administration whose staff is almost half pharmacists. The Division of Drug Advertising consists of Director Peter Rheinstein, and nine staff. It handles nearly 1000 complaints, submissions and inquiries a month. DDA takes hundreds of regulatory and advisory actions every year. Ads are not subject to preclearance, but all new promotional material for products with New Drug Applications must be submitted to the FDA. Sometimes manufacturers seek prior advice. But most DDA activities are remedial. The most common remedy is a notice of violation. Other remedies include seizure of misbranded drugs, injunction, and criminal prosecution. The most effective way to notify health practitioners about advertising violations is a ‘Dear Doctor’ letter, but postage is expensive, so they are reserved for fairly significant violations. Last year one was sent. Remedial ads require publication of boxed statements saying they are replacing ads found misleading by the FDA. Keeping the FDA happy is not simple. The government/manufacturer relationship is one of friendly adversaries. FDA’s approach to violations varies from polite to autocratic. One type of letter is low-key advisory letters; another type is regulatory letters that become part of the public record. DDA also has ongoing research projects focusing on whether ads are misleading. Another activity is trend analysis. Notable trends include targeting of pharmacists, and generic versus brand-name advertising, and DTCA. DDA staff monitor 80-odd professional journals and handle complaints received through the Drug Defect Reporting System and even get input from competing companies. Staff also meet with foreign counterparts. A pharmacy background is extremely useful for staff, but medical officers are consulted.

Keywords:
analysis/United States/