Healthy Skepticism Library item: 8217

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

Wood J, Rupright P.
Erosion of the learned intermediary rule
Pharmaceutical Executive 1997 Oct; 17:104, 106, 108, 110

Abstract:

The erosion of the learned intermediary rule, which provides liability protection to companies that manufacture prescription medicines and devices, by regulatory and marketing developments such as direct-to-consumer advertising in the United States and internationally, the Internet and companies’ World Wide Web home pages, the Omnibus Budget Reconciliation Act of 1990 (OBRA 1990), which places pharmacists as an intermediary between the physician and patient, and new U.S. Food and Drug Administration (FDA) requirements and recommendations about the provision of patient package inserts and brochures by the pharmaceutical industry is examined.