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Medical Device User Fees & FDA Reform Among Congress Priorities |
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Thursday, January 19 2012 |
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Congress Gears up for Drug and Medical Device User Fee Reauthorization and FDA Reform—Many of MedIC’s Goals included in Congress’ Priorities
This year is a critical one for advancing our FDA reform priorities since Congress must reauthorize the Prescription Drug User Fee (PDUFA) and Medical Device User Fee (MDUFA) programs which expire in September. These bills provide germane legislative vehicles for broader FDA reforms. Interestingly, there is a genuine bipartisan effort in Congress to pass broad FDA reform legislation; several bills have already been introduced that address many of MedIC’s FDA reform priorities. MedIC’s priorities include:
- Encourage FDA to approve cancer treatments;
- Provide a new paradigm for an accelerated approval for critical therapies;
- Reform the Advisory Committee process to promote difference of opinion on Advisory Boards;
- Propose a flexible risk-benefit assessment whereby FDA may consider “probable” risks and benefits;
- Require FDA to comply with the “least burdensome” provisions for medical devices;
- Require FDA to be more predictable in its submission requirements;
- Allow FDA to have access to and consult with external experts;
- Make it easier for sponsors to rely on foreign data in FDA regulatory decisions;
- Reform the medical device appeals process.
MedIC is working closely with both the Senate and House authorizing committees, Senate Health Education Labor and Pensions and House Energy and Commerce to ensure our key priorities are included in the broader FDA reform proposals that will be introduced. We are also coordinating efforts with BIO, MDMA and several key patient organizations to help provide a consistent message on the legislative needs to keep the development of new therapies and medical devices and new jobs in the U.S.
Congressional Time for FDA Reform: Beginning in February, the House Energy and Senate Health Education, Labor and Pensions Committees will begin to hold hearings on the PDUFA and MDUFA agreements which expire September 30. Both committees will hold additional hearings aimed at making the case for broader FDA reforms that can be attached to the PDUFA and MDUFA reauthorization bills. Both committees plan to move legislation by April and hope to have the measures passed by both the Senate and House by early summer. However, it is more likely these bills won’t get passed until late September—closer to the reauthorization deadline. MedIC will continue to work closely with likeminded groups to move our key priorities forward and get them included into the reauthorization packages.
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