Yesterday, 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). Since 2002, MDUFA has required that the Food and Drug Administration collect fees from medical device companies seeking approval for devices they want to market in the U.S.
The reauthorization of the user-fee program is nothing new. However, the 14 bills introduced in Congress that threaten device regulation are indeed the latest attack on patient safety.
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.
Public Citizen’s new report, Substantially Unsafe, reveals that this $350 billion industry dispatched 225 lobbyists, including 107 who previously worked in 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.













In record numbers, public citizens call for strong Volcker Rule
By: Editor
By Rick Claypool and Bartlett Naylor
Flickr photo by wintersoul1
The Wall Street Journal’s Victoria McGrane reports:
More than 15,700 of those comments came from activists mobilized by Public Citizen’s online organizing efforts.
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