Testimony before the Committee on Energy and Commerce Subcommittee on Health
Allan Coukell, Director of Medical Programs, Pew Health Group

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Since 1992, user fee agreements have given FDA significant and sustained resources that allow the agency to review new products quickly. In fact, preliminary findings of a study that Pew has funded show that FDA reviews new drugs faster than its counterparts in the European Union and Canada.

• The user fee legislation is also an important opportunity to consider key updates to the Food, Drug and Cosmetic Act that will protect Americans and support innovation, in particular:
  Drug supply chain safety: FDA needs regulatory systems that are appropriate for today’s global supply chain.
• Medical device safety and innovation: We urge the Committee to include legislation to create a more robust system of post-marketing surveillance, which would promote safety by identifying problematic medical devices more quickly.
• It would also facilitate innovation by increasing confidence in the safety of medical devices on the marketplace. Antibiotic development: We urge the Committee to include the Generating Antibiotic Incentive Now Act, which would provide economic incentives to stimulate the development of new antibiotics.

The user fee agreements are essential to an effective FDA that can foster innovation while ensuring the safety and efficacy of the products we depend. We urge Congress to swiftly reauthorize this program with three important additions - drug supply chain safety, medical device safety and innovation, and antibiotic development.