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May 10, 2012 

Key House Committee to Vote on Legislation That Would Weaken Medical Device and Prescription Drug Regulations

Statement of Dr. Michael Carome, Deputy Director, Public Citizen’s Health Research Group

This morning, the U.S. House of Representatives Energy and Commerce Committee will meet to deliberate and vote on legislation that bows to the powerful interests of industry by weakening medical device and prescription drug safety.

The primary purpose of the bill is to renew and extend the Food and Drug Administration’s (FDA) user-fee programs for prescription drugs and medical devices, fees that the agency has become dependent on to fund much of its critical regulatory work because of inadequate direct funding being provided by Congress. However, the bill includes many provisions unrelated to user fees that would amend medical device and prescription drug regulations.

While the bill being considered by the committee today contains some important improvements in comparison to earlier drafts of the bill – which we strongly opposed – the limited number of positive provisions in the revised bill still is offset by:

(1) The inclusion of multiple provisions sought by industry that would weaken the already inadequate oversight of medical devices and drugs and pose a risk to the health and lives of patients; and

(2) The exclusion of several simple, commonsense proposals for strengthening medical device safety opposed by industry.

Therefore, in balance, this bill would have an overall negative impact on medical device and drug safety, and we oppose its passage unless significant amendments are made. For example, a provision should be added closing the dangerous loophole in what is known as the 510(k) process that allows the FDA to clear a new moderate- or high-risk device for marketing based on its similarity to an older device already on the market, even if the older device has been removed from the market because it injures or kills patients. Another provision should be added prohibiting the FDA from clearing class III medical devices – the most risky type of devices – from being cleared through the 510(k) process and instead require the agency to review such devices under the more rigorous premarket approval application process.

Ensuring that the medical devices and drugs used to treat patients in the U.S. are safe and effective should be the paramount goal of any new medical device and prescription drug legislation. Patients in the U.S. deserve legislation that strengthens the FDA’s review and oversight of these medical products to ensure their safety and effectiveness, not legislation that seeks to promote the corporate interests and profits of industry by weakening such review and oversight.

See our detailed review and analysis of the House bill. Get more background here.

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