Medical Devices Law & Industry Report provides complete in-depth, interdisciplinary news coverage of all major developments in the rapidly changing medical...
By Nathaniel Weixel
Draft legislation in the House for the reauthorization of medical device user fees should be rejected by Congress, a consumer advocacy group said March 20.
According to Consumers Union, the policy and advocacy arm of Consumer Reports, the House Energy and Commerce Health Subcommittee's draft bill would significantly weaken device safety oversight and should be rejected.
Both the House panel and the Senate Health, Education, Labor and Pensions Committee have released discussion drafts outlining policy changes to the Food and Drug Administration's regulatory process for bringing medical devices to market. However, according to Consumers Union, the Senate bill also addresses some safety oversight. The draft bills are the first step in the process of reauthorizing the Medical Device User Fee Act (MDUFA) for fiscal years 2013 through 2017.
MDUFA authorizes FDA to collect user fees and use them for the process of reviewing medical device applications. The current legislative authority for MDUFA expires Oct. 1, and new legislation will be required for FDA to collect medical device user fees for the future. The industry-paid fees supplement congressional appropriations for FDA.
Lisa Swirsky, senior policy analyst for Consumers Union, said in a statement that the House bill “weakens current standards to speed up device approvals rather than improving safety oversight. The Senate bill offers some improvements but it should be strengthened to require stricter safety testing of new implants and life sustaining devices.”
Swirsky noted that while the Senate draft bill provides some additional protections for patients once devices are on the market, “it misses the opportunity to enact a clear process for preventing unsafe devices from being sold in the first place. Congress should recognize that the public is far more concerned about making sure devices are safe and work than how quickly they are made available.”
The House bill was generated by Republican leadership, while the Senate version was a bipartisan effort.
According to the Senate HELP Committee, the discussion draft on user fees reflects “bipartisan efforts to develop consensus policy proposals to accompany the FDA human medical product user fee legislation. The [draft]… should encourage discussion. [The draft does] not represent a completed product, but rather the start of bipartisan work that will hopefully lead to consensus language to be marked up. Our goal is to solicit feedback on the policy merits, potential unintended consequences, and potential opportunities to improve the legislative language.”
The Senate committee is asking for feedback on its draft by April 1.
FDA March 15 said it finished negotiations with industry and announced a public meeting to discuss proposed recommendations for MDUFA reauthorization. The public meeting will be held March 28 at the Department of Health and Human Services in Washington (see related item).
The agency is not able to send its plan to Congress until after the meeting and a 30-day public comment period.
In the House draft, many of the proposed regulatory changes mirror those included in a series of bills introduced in October 2011 that would reform the FDA device approval process to protect innovation (5 MELR 639, 10/19/11).
The 10 bills, all sponsored by Republicans, would provide solutions to improve the predictability, consistency, and transparency of FDA's medical device review and approval process, the Energy and Commerce Committee said at the time. The package was called Saving American Jobs and Saving American Patients.
For example, the House user fee draft bill includes a provision that would require FDA to solicit public input on all draft guidances. The draft also aims to streamline the de novo pathway for novel medical devices by removing the need for a 510(k) premarket notification submission to be found “not substantially equivalent.”
The de novo process involves reviews of devices that do not have a substantially equivalent product already on the market.
The Senate draft is at http://op.bna.com/hl.nsf/r?Open=nwel-8skmjt.
The House draft is at http://op.bna.com/hl.nsf/r?Open=nwel-8skm9l.
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