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FDA Commissioner Marty Makary's comments bode well for biopharma's prospects of efficiently commercializing new drugs, per Jefferies analysts.

Why it matters: Industry insiders have reported worries about slowdowns at the agency amid high-profile departures and changing leadership at the FDA.

Driving the news: Makary made an appearance at the Jefferies Global Healthcare Conference in New York on Wednesday, discussing everything from drug pricing to AI.

One analyst wrote in a report that Makary's comments "resonate well" for biotech.

Behind the scenes: Makary discussed constructive collaboration with the biopharma industry to improve and accelerate the drug development and approval process, per the analysts' reports.

Despite high-profile departures from the FDA and other recent staffing changes, Makary indicated that staffing changes have so far not impacted clinical reviewers, saying "trains are running on time."

Instead, staffing changes were focused on consolidating redundancies at the agency, Makary said.

While drug pricing and the recently proposed MFN policy are outside the FDA's purview, Makary said streamlining the drug development and FDA approval process could help shrink R&D costs for manufacturers, eventually leading to lower price tags, per the reports.

Rare disease approvals appear to be a priority, with Makary saying the FDA will continue to customize and optimize the approval process.

What they're saying: "We found Dr. Makary's comments (positive) and pragmatic for the biotech industry," wrote Jefferies equity analyst Michael Yee in a report.

The latest: Despite recent moves by Health Secretary Robert F. Kennedy Jr. to move away from broad COVID vaccine boosters, Makary emphasized his medical background at the conference, telling the audience that "vaccines save lives."

What's next: The FDA will continue incorporating AI into the drug review process to make it more efficient, Makary said.

The bottom line: Jefferies equity analyst Andrew Tsai wrote that the bank's analysis "suggests operations seem fine," adding that "fears (of) a dysfunctional FDA might be overblown."

Makary appearance tempers biotech fears

Analysts say fears of dysfunctional FDA may be "overblown."

From left: Mark McKenna, CEO of Mirador Therapeutics; George Tidmarsh, adjunct professor of pediatrics and neonatology at Stanford; and FDA Commissioner Marty Makary. Photo: Jefferies

FDA Commissioner Marty Makary&#x27;s comments bode well for <a class="gtmContentClick" data-vars-link-text="biopharma&#x27;s" data-vars-click-url="https://www.axios.com/pro/biotech-deals/2025/05/19/biopharma-correction-first-quarter" data-vars-content-id="a01188e4-2ae4-4fdc-ad02-1cc90fc05828" data-vars-headline="Makary appearance tempers biotech fears" data-vars-event-category="story" data-vars-sub-category="story" data-vars-item="in_content_link" href="https://www.axios.com/pro/biotech-deals/2025/05/19/biopharma-correction-first-quarter" target="_self">biopharma&#x27;s</a> prospects of efficiently commercializing new drugs, per Jefferies analysts.Why it matters: Industry insiders have <a class="gtmContentClick" data-vars-link-text="reported worries" data-vars-click-url="https://www.axios.com/pro/biotech-deals/2025/04/28/fda-upheaval-vc-biotech-deals" data-vars-content-id="a01188e4-2ae4-4fdc-ad02-1cc90fc05828" data-vars-headline="Makary appearance tempers biotech fears" data-vars-event-category="story" data-vars-sub-category="story" data-vars-item="in_content_link" href="https://www.axios.com/pro/biotech-deals/2025/04/28/fda-upheaval-vc-biotech-deals" target="_self">reported worries</a> about slowdowns at the agency amid high-profile departures and changing leadership at the FDA.

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Makary appearance tempers biotech fears

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