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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President Trump's eleventh-hour signature on the FDA Reauthorization Act puts into play about $1bn in device user-fee collections from industry through FY 2022, new US FDA performance goals and a range of device process enhancements and reforms supported by industry.
The Trump White House is not backing down in its push to renegotiate the US FDA user-fee reauthorization deals that were inked during the Obama administration. The FY 2018 budget request would ask for more than a $200m increase in fees from device companies in the coming fiscal year to counterbalance major cuts in appropriations from Congress. That would make the agency's device program dependent on user fees for about 71% of its budget, versus about 27% currently. But Congress has already said it opposes the plan.
New US FDA Commissioner Scott Gottlieb made only one direct mention of medical devices in his first speech to the agency, highlighting the promise of devices that empower consumers to be "better stewards of their own care." Gottlieb has been a strong proponent of FDA largely staying out of the oversight of many products in this category, in particular, DTC gene tests and digital-health tools.