US FDA User Fee Legislation: Is Sen. Burr’s ‘Clean’ Bill A Lifeline – Or A Wrench In The Works?
Sen. Richard Burr introduces a reauthorization bill without any policy changes, even ones he previously endorsed, saying it’s the clearest path forward now.
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The FDA had picked grantees for the initial round of biosimilar regulatory science research, but told them not to start major activities until the user fee reauthorization was assured. Congress now appears to have reached deal for a ‘practically clean’ reauthorization.
The month of September will be a crucial time for the US Food & Drug Administration and the legacy of its commissioner, Robert Califf. The agency will be taking several significant regulatory actions – but also crossing its fingers that legislation to assure its funding is secured.
A quickened shift toward gene therapies for small populations may be the result of the new Medicare drug pricing law given protections afforded to those types of products.