April 20, 2012 ~ Ask most Americans and they would say that the role of the U.S. Food and Drug Administration (FDA) is to protect us from unsafe food, medications and medical devices.
Congressman Mike Rogers (R-MI) would like to expand the role of the FDA to include jobs promotion and growth for industry, a sort of goodwill ambassador for the corporations he represents in Congress. Rep. Rogers wrote an amendment to the User Fee Act that would expand the agency’s role to “promoting economic growth, innovation, competitiveness, and job creation among the industries regulated by this Act.”
He is taking such a proactive role that Rogers has even posted a video segment on his YouTube channel showing him grilling medical devices chief Jeffrey Shuren M.D. in February during a hearing of the Health subcommittee of the House Energy and Commerce Committee. Shuren was asked if he was concerned that a recent report said 36% of venture firms with the National Venture Capital Association planned to take investments to Europe and 44% planned to invest in Asia?
Fortune Magazine (here) reports that the top industries to donate to Rep. Rogers campaigns since he was elected to Congress in 2000 are health professionals, insurance and pharmaceuticals/health products according to research by the Center for Responsive Politics contributing more than $1.6 million. (See his coffers here).
Despite the fact that 78 percent of high-risk medical devices are reviewed through the FDA's fast track 510(k) process, industry lobbyists have urged Congress to ease federal oversight in order to promote innovation and speed up new device approvals. And according to a March 2012 Consumer Reports poll, 82 percent of Americans believe that preventing safety problems is more important than limiting safety testing in order to prevent delays and encourage innovation.
The amendment is part of the U.S. House version of the FDA’s user fee reauthorization. User fees come from industry to fund medical device reviews and the industry has agreed to pay $595 million if it receives in return faster reviews to get medical devices onto the market. (Background story here.)
The Medical Device User Fee & Modernization Act (MDUFA) must be passed by the last day of September to ensure the continuation of medical device reviews by the FDA. Congress must approval MDUFA and House and Senate Committees will vote next week.
The Senate Health, Education, Labor and Pensions Committee will hold a mark-up of its bill to reauthorize the Medical Device User Fee Act on Wednesday, April 25. The House Energy and Commerce Committee's Health Subcommittee will mark up its bill on Thursday, April 26.
Where is Patient Safety?
Consumer and patient groups testified and reminded the committee that nowhere was patient safety even mentioned in the MDUFA reauthorization. The House bill wants to speed up approvals and focuses on how quickly medical devices can be made available.
Last year, Rep. Rogers introduced the FDA Mission Reform Act to increase the job promotion efforts by the FDA.
Public Citizen has complained to the subcommittee that promoting innovation overshadows the FDA’s primary mission of protecting the public health calling it a “very bad idea,” and Consumers Union joined in rejecting Rep. Roger’s proposal. #
Here is a news release from Consumers Union
Consumer Reports Poll on Medical Device Safety Oversight, March 20, 2012
Feb. 14 2012 ~ What is MDUFA? Hearings on $595 Million and What Industry Wants
Open Secrets on Rep. Rogers’ funding
Rogers’ YouTube Videos