Scott Gottlieb, who served as US Food and Drug Administration commissioner during the first half of President Trump’s first term, advised the pharmaceutical industry to seek a legislative extension of the user fee program because he sees “nothing good” coming from negotiating new agreements in the “current political environment.”
User Fees: Industry Should Push For Extension Of Current Agreement In Reconciliation Bill, Gottlieb Says
Trump’s former FDA commissioner sees ‘nothing good’ coming from negotiating a new user fee agreement in the ‘current political environment.’
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Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.
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FDA staffing cuts are making negotiation preparations more difficult, but also could mean the result is a smaller user fee renewal package.
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Republican congressional staffers could bring a wealth of experience and strong contacts with key legislators to the FDA ahead of the next user fee reauthorization process. But will Health and Human Services Department leadership interfere?
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Multiple sources, including former Acting FDA Commissioner Janet Woodcock, told the Pink Sheet that industry is quietly complaining about FDA work delays and they expect the problem will worsen.
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Center for Biologics Evaluation and Research Director Peter Marks expects no fundamental changes in support for FDA initiatives and said the Rare Disease Innovation Hub, which promotes cross-center collaboration, is “consistent with what we're hearing in the current environment.”
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Sponsors should consider the DTC ad's audio as the major statement about a prescription drug’s side effects and then choose strategically how to display the accompanying text. TV ads are now employing banners and larger text to satisfy the rule’s “dual modality” requirement.
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Given the Trump Administration’s intense focus on cutting costs and increasing efficiency, industry and the FDA should focus on what is and is not working in PDUFA VII when negotiating the next agreement, lobbyists said at the BIO CEO and Investor Conference.