Faster, Safer Access to New Medicines and Devices One Step Closer to Passage

Press Release

A Senate committee passed a bipartisan effort today that will help make medicine safer for children. It will also help ensure American patients have access to safe and innovative medicine and devices, according to U.S. Senator Mike Enzi, R-Wyo., the Ranking Member of the Senate Health, Education, Labor and Pensions (HELP) Committee, which approved the bill.

The bill reauthorized FDA user fees, which drug and medical device companies pay to the FDA when they submit a new product for approval. The FDA uses the fees to cover the costs of approving the products. The fees were set to expire in September, which would have delayed access to new medicines and slowed safety trials.

Enzi joined the Chairman of the HELP Committee, Sen. Tom Harkin, D-Iowa., in saying, "Today's markup of the user fee agreement reauthorizations was an important step. At a time when Congress has been deeply divided, today's markup displayed strong bipartisan cooperation."

The bill aims to bring important products to the market quickly (such as generic drugs or products intended to treat life-threatening diseases) while improving oversight of potential safety issues. The FDA will also be required to update its record-keeping requirement in efforts to track down contaminated products throughout the supply chain.

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