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Troubles at the Food & Drug Administration

Last Friday, the Institute of Medicine, part of the National Academy of Science, released a report titled The Future of Drug Safety: Promoting and Protecting the Health of the Public. According to the IOM’s summary, the report findings include:

There is a perception of crisis that has compromised the credibility of FDA and of the pharmaceutical industry.

Most stakeholders–the agency, the industry, consumer organizations, Congress, professional societies, health care entities–appear to agree on the need for certain improvements in the system.

The drug safety system is impaired by the following factors: serious resource constraints that weaken the quality and quantity of the science that is brought to bear on drug safety; an organizational culture in CDER that is not optimally functional; and unclear and insufficient regulatory authorities particularly with respect to enforcement.

FDA and the pharmaceutical industry do not consistently demonstrate accountability and transparency to the public by communicating safety concerns in a timely and effective fashion.

The report included several recommendations to help alleviate these problems. Those recommendations include:

Labeling requirements and advertising limits for new medications

Clarified authority and additional enforcement tools for the agency

Clarification of FDA’s role in gathering and communicating additional information on marketed products’ risks and benefits

Mandatory registration of clinical trial results to facilitate public access to drug safety information

An increased role for FDA’s drug safety staff

A large boost in funding and staffing for the agency

The New York Times ran an article describing the study and the FDA’s response this weekend.

The FDA, and these problems, are obviously important to the protection of the nation’s health. But they’re also important in drug litigation in Texas. As a result of 2003 legislative changes, drug manufacturers receive a rebuttable presumption that warnings with their drugs were adequate if the FDA approved the warnings. It can be very difficult for injured Texans to overcome this presumption. For example, an injured plaintiff can overcome this presumption by proving that the manufacturer withheld or misrepresented information to the FDA, by showing that the manufacturer continued to sell the product after the FDA ordered it withdrawn from the market, or that the manufacturer promoted or advertised the product for some unauthorized use. This is a complicated area of the law, and if you or someone you know has been injured as a result of medication, you should contact an attorney as soon as possible.

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