Archive for February 16th, 2012

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.

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"dr wolfe"Public Citizen applauds the strong efforts of a bipartisan group of U.S. senators who on Wednesday asked the Office of Inspector General (OIG) at the Department of Health and Human Services (HHS) to resume its long-neglected oversight over state medical boards. HHS partly funds medical services for 105 million people through Medicare and Medicaid and thus has an important interest in the appropriate discipline of the hundreds of thousands of U.S. doctors who take care of these patients. Starting in the 1980s, the HHS OIG conducted a number of investigations of state medical boards, but it has not completed a comprehensive evaluation of state medical boards in more than 15 years, the senators’ letter said.

Sens. Charles Grassley (R-Iowa), Orrin Hatch (R-Utah) and Max Baucus (D-Mont.) noted in their request the Public Citizen finding in March 2011 that medical boards failed to take action against 220 physicians who were considered an “immediate threat to health or safety of patients” – 75 percent of whom had had their clinical privileges suspended on an “emergency basis.” The senators called on the OIG to conduct an evaluation of state medical boards’ performance. They also reiterated concerns – expressed by Public Citizen in a March 15, 2011, letter to HHS Secretary Kathleen Sebelius – that a state medical board licensure action against a physician provides greater patient protection from questionable physicians than a hospital clinical privilege action alone.

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By Rick Claypool and Bartlett Naylor

Flickr photo by wintersoul1

The Wall Street Journal’s Victoria McGrane reports:

The so-called Volcker Rule has broken the record for attracting the most comment letters submitted on any Dodd-Frank proposal.

Regulators have received a whopping 17,000-plus comments on the proposal, a Federal Reserve spokeswoman said. And some poor junior-level staffers are still counting them. The rule restricts U.S. banks from making bets with their own money.

More than 15,700 of those comments came from activists mobilized by Public Citizen’s online organizing efforts.

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