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Issue Brief
Testimony before the Committee on Energy and Commerce Subcommittee on Health
Allan Coukell, Director of Medical Programs, Pew Health Group
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.
Full Testimony
The Pew Charitable Trusts and the Premier healthcare alliance sent the White House Office of Management and Budget a letter regarding the review of a Food and Drug Administration rule to establish a unique device identifier (UDI) system. Given the importance of this new device identification system to improve patient care and the missed statutory deadline, in this correspondence Josh Rising of Pew and Blair Childs of Premier strongly urged the Director of the Office of Management and Budget (OMB) to promptly complete review of the UDI final rule.
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A letter from Josh Rising — director of Pew's Medical Device Initiative — to The White House Office of Management and Budget, requesting a speedy review of regulations to develop a unique device identifier (UDI) system.
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'You may not yet depend on a pacemaker, defibrillator, stent, joint implant or any of the other life-changing, potentially lifesaving products made by the medical device industry. But chances are you or a family member will be a patient some day. That’s why it isn’t just the medical device industry that has a stake in the timely rollout of a long-overdue national system to better track the safety and whereabouts of devices once they’re on the market or in use."
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A letter from Josh Rising, director of Pew's Medical Device Initiative, about updates on the unique device identifier system.
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Pew sent a comment letter to the Senate Committee on Health, Education, Labor and Pensions on the Pharmaceutical Compounding Quality and Accountability Act. This bill takes steps toward clarifying state and federal oversight of compounding, including an important increase in FDA supervision of certain activities—specifically, the compounding of sterile medicines that are shipped interstate.
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