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Post-Approval Studies May Reveal Safety Problems

FDA Creates Web Page Concerning Post-Approval Testing of Medical Devices

WASHINGTON, DC -- April 13, 2007 -- The Food and Drug Administration (FDA) has created a new web page that shows the status of recently approved medical devices. Medical devices include heart defibrillators, pacemakers, breast implants, stents, and even hip replacement parts.

The FDA admits that it sometimes "approves a medical device before all long-term questions about its safety and effectiveness have been answered." As a result, the agency may allow a medical device to go on the market while requiring the manufacturer to perform a large-scale study about the device's safety and effectiveness. This study is called a "post approval study," and must now be listed on the agency's web site. A recent check of that web site showed that the FDA required a 10-year follow-up study of women with breast implants, a one-year report on adults and children with cochlear implants and a five-year study on patients who received urinary control systems.

The web page only lists post approval studies that began after January 1, 2005. It is updated once a month. Each listing includes the company's name, the product's name, the approval number and date, and describes the study and whether it is meeting reporting deadlines. No information on clinical data is available, but at least the web site alerts doctors and the public when there are unanswered questions.

FDA Also Proposes New Procedures for Membership on Its Advisory Committees

The FDA has also proposed a new rule for determining who may sit on its advisory committee, which provides recommendations concerning medical devices and medical drugs (FDA Press Release, March 21, 2007). The FDA gives these opinions great weight, but is not obligated to follow them.

Currently, the FDA screens all prospective advisory committee members before each meeting to see if they may have ties with drug manufacturers that constitute financial conflicts of interest. The agency may grant a waiver if the need for an individual's expertise outweighs the potential for a conflict of interest.

The proposed rule would tighten the waiver policy by disqualifying an individual whose financial interest exceeds $50,000. If a financial interest exists, but it is $50,000 or less, then the individual might still be allowed to participate, but as a non-voting advisory committee member.

FDA Attempts to Improve Its Image

Both the proposed FDA advisory committee rule and the new web page are attempts by the FDA to better connect with the public and to improve its tarnished image. The agency has been roundly criticized for not taking harsher measures in handling the marketing of Vioxx®, an arthritis drug that was finally recalled in September 2004, for its role in delaying warnings about certain antidepressants, and most recently, for its failure to catch problems that led to a massive pet food recall. Many feel that the FDA needs a bigger budget, more staff and more authority to do its job properly; others believe that a complete overhaul of the agency is in order.

Drug and Medical Device Safety

Brayton Purcell is concerned about sales of unsafe prescription drugs and medical devices. For more information, please read our sections entitled Defective Medical Devices and Injuries from Medical Drugs. If you have been injured by an unsafe medical device or drug, please feel free to contact us for a free evaluation of your potential case.

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