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Amanda Fleming
Amanda Fleming
Contributor • (202) 588-7734

An Absurd Double Standard in the Medical Device Industry

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A medical device that is implanted inside your body should be at least as safe as a pill you ingest, right? In reality, the Food and Drug Administration’s (FDA) standards for allowing new medical devices on the market are significantly lower than its standards for approving drugs.

Last week, the Health Subcommittee of the U.S. House Committee on Energy and Commerce held a hearing on the reauthorization of the Medical Device User Fee Act (MDUFA).

The reauthorization of the user-fee program is routine, but this time, 14 bills were introduced in Congress that threaten device regulation. They are indeed the latest attack on patient safety. Public Citizen submitted testimony for the hearing on Feb. 16.

U.S. Rep. Henry Waxman (D-Calif.) called the bills in the House “industry’s wish list,” fulfilling most of the device industry’s desires to reduce already weak standards for approving medical devices and, thereby, expedite devices’ path to market.

A new report, Substantially Unsafe, reveals that this $350 billion industry dispatched 225 lobbyists, including 107 who previously worked for the federal government, to lobby on medical device regulatory issues in the 3rd and 4th quarters of 2011. The industry’s resources surged in the 4th quarter, when an additional 96 lobbyists (of the 225) and 23 new companies (of 53) joined the campaign. The device industry spent $33.3 million lobbying Congress in 2011.

Public Citizen is compiling stories of people harmed by medical devices and is encouraging our members and those who care about this issue to tell Congress to end the absurd double standard. High-risk medical devices, including those that are permanently implanted, should be at least as safe as pharmaceuticals.

I hope you can help by letting me know if you have any former clients who may want to share their stories. Please call me at 202-588-7734 or email me at afleming@citizen.org if you have any good examples we might be able to use, and send a note to your member of Congress today.