Healthy Skepticism Library item: 3478

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

Yellin AK.
FDA prescription drug enforcement policies and techniques
Food Drug Cosmetic Law Journal 1987; 42:552-558

Abstract:

This paper explains the FDA enforcement policies and techniques in the regulation of promotional materials for prescription drugs. Drug promotion is a five billion dollar per year activity, which comes to the FDA’s attention through routine surveillance, industry complaints, and inquiries or complaints from tother quarters. The FDA prefers amicable discussion of issues. It uses preventive letters and guidance statements. It generally has an excellent relationship with the trade press. It does not profess to be infallible and will consider reasonable arguments based on scientific data.

Keywords:
*policy statement & guideline/United States/