MedIC Ends First Year Strong PDF Print E-mail
Tuesday, December 20 2011

2012 Promises To Be Critical For FDA Reform

NVCA's Medical Innovation and Competitiveness Coalition (MedIC) reached its one year anniversary and made a big footprint in Washington and gained significant traction in moving its FDA reform goals forward. MedIC ended the year strong by releasing the results of a survey of the venture capital industry showing that investment in biotechnology and medical technology is being strongly and adversely affected by FDA uncertainties and delays. This was presented on Capitol Hill by Senators Bennet and Burr as well as Congressman Burgess.

During 2011 MedIC also:

  • Developed key relationships with members of Congress, senior White House officials and leaders at HHS, FDA, and CMS and increased the awareness of the threats to jobs and U.S. competitiveness;
  • Participated in White House taskforce, committees and meetings on FDA regulatory issues;
  • Partnered with MDMA on a study by Dr. Josh Makower that highlighted the additional time and capital required for medical devices approval in the U.S. compared to Europe;
  • Developed comprehensive FDA Reform priorities to share with Congress and the Administration;
  • Testified three times before Congress on the impact FDA is having on drug and medical device innovation;
  • Commented on five FDA draft guidances focused on improving to review process for medical devices;
  • Educated and partnered with other healthcare trade, patient groups and coalitions to help advance mutual goals, and;
  • Hosted two Washington DC fly-ins for MedIC members.

Next year will be a critical year for our FDA reform efforts since Congress must reauthorize the FDA user fee programs for drugs and medical devices which expire in September. The user fee reauthorization will provide a germane legislative vehicle for board FDA reforms. Interestingly, there is a genuine bi-partisan effort in Congress to pass board FDA reform legislation and several bills have already introduced legislation that addresses many of MedIC’s FDA reform priorities.

For example, Senators Klobuchar (D-MN), Bennet (D-CO) and Burr (R-NC) introduced the Medical Device Regulatory Improvement Act, which would streamline the FDA’s regulation of medical devices by clarifying FDA’s current least burdensome requirements; restore the appropriate balance to conflicts of interest requirements by requiring the FDA to be subject to the same conflicts of interest requirements as the rest of the federal government and; direct the FDA to contract with an outside entity to conduct a thorough review of the management and regulatory processes at the FDA’s Center for Devices and Radiological Health, including the impact on medical device innovation. Several members in the House introduced the “Saving American Jobs and Saving American Patients” legislative package. This package of bills reflect the House Energy and Commerce Committee’s extensive work in examining the need for FDA reform through a series of hearings that have been conducted over the year. Several NVCA and MedIC members testified before the Committee on the impact FDA is having on medical innovation. You can view a summary of the legislation by clicking here.

Also, Senators Hagan (D-NC) and Bennet (D-CO) and several other members are interested introducing legislation to establish a new progressive approval pathway for new treatments in areas of unmet medical need which is one of MedIC’s top priorities.

Congress will begin to move both user fee reauthorization and broader FDA reform bills through the legislative process in February. Several additional bills will be introduced and marked up by springtime. It is Congress’ goal to have all these bills completed and passed by the beginning of summer. 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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