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Gottlieb Becomes FDA Commissioner With Immediate Issues Pending

Executive Summary

Confirmation comes with fewest votes of any recent commissioner as FDA dealing with budget, user fees and other issues.

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Attorneys predict the upcoming Biden administration will try to quickly fill top leadership positions at the HHS and the FDA, and note that January’s two Senate runoff elections in Georgia could decide the fate of the Affordable Care Act before the Supreme Court does.

With Gottlieb Sworn In, His Focus Should Be On Quick User-Fee Passage, Industry Advocates Say

Scott Gottlieb was sworn in as US FDA commissioner May 11. Device-industry lobbyists say championing quick passage of user-fee reauthorization should be his near-term priority. Gottlieb is a well-known figure by some in industry, including AdvaMed chief Scott Whitaker, who served with him at HHS during the George W. Bush Administration.

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The Senate HELP Committee is ready to mark up user-fee reauthorization legislation May 10 that includes several device add-ons to the core industry-FDA agreement. Most of the additional reforms are supported by industry, but staffers have warned that putting too much extra legislative baggage into the user-fee package could slow it down. Reforms included address device facility inspections, device accessories' classification and post-market surveillance, among other issues.

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