Healthy Skepticism Library item: 16549

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: news

Arnold M
Physician's group wants new drug labeling, 2-year DTC moratorium
Medical Marketing & Media 2009 Sep 25
http://www.mmm-online.com/Physicians-group-wants-new-drug-labeling-2-year-DTC-moratorium/article/149797

Full text:

The American College of Physicians (ACP) called for the FDA to be empowered to label newer drugs as such and to restrict consumer advertising of them.

In a policy paper titled Improving FDA Regulation of Prescription Drugs, the group, which claims a membership of 129,000 internal medicine physicians, related sub-specialists and medical students, said the agency needs more funding and greater powers. Among them, ACP argues that FDA should be authorized to require that new drugs carry labeling indicating their new-to-market status and that DTC advertising be restricted for the first two years a drug is on the market.

ACP also called for FDA to: increase their capacity to regulate drugs manufactured outside the US through appropriations and user fees; be given expanded authority in design of pre-approval trials and studies; ban “bundling of drugs that limits marketability and availability”; and improve the adverse events reporting system.