Makary 离开 FDA 后生物医药界松口气：Signal 调查显示监管情绪回升

When Endpoints Signal released the Q3 Biopharma Sentiment Index last week, it showed a level of industry optimism not seen in years. Behind the topline figure, one area of improvement really stood out: the regulatory environment. The Q3 Biopharma Sentiment Index (we call it the BPSI) is based on our survey of 569 industry insiders and was the first fielded since Marty Makary resigned as FDA commissioner on May 12. It's the closest thing we have to a before-and-after reading of his exit, and the verdict was pretty clear: Relief. In a quarter where overall sentiment moved firmly into positive territory for the first time since the post-pandemic crash, regulation was the only area where pessimists still outnumbered optimists. But the gap is closing fast. The relative score for current regulatory conditions increased to 75, from 50 in Q2 and a miserable reading of just 23 a year ago. A score of 100 would indicate neutral sentiment. “I’m hopeful that stability will return to the FDA now that some of the most egregious leadership is gone,” wrote a biotech C-suite executive with more than 20 years of experience in the field. “But there has been substantial damage.” if (!window.__epChartHeightListener) { window.__epChartHeightListener = true; window.addEventListener('message', function(e) { if (e.data && e.data) { var h = e.data.height; var frames = document.querySelectorAll('iframe'); for (var i = 0; i < frames.length; i++) { if (frames.contentWindow === e.source) { frames.style.height = h + 'px'; break; } } } }); } The recent improvement mirrors the jump in regulatory sentiment following the departure of FDA biologics chief Vinay Prasad in April. Prior to those two officials stepping down, discontent was nearly universal. In February, following the Q1 survey, I wrote about the hailstorm of hundreds of open-field complaints about the upheval in Washington. Only President Donald Trump received more criticism than Makary and Prasad. The evolution in sentiment hasn't been uniform. The money side of the industry moved most: At finance and investment firms, 40% of respondents now call the environment more supportive than a year ago and 23% less supportive, nearly the reverse of the prior quarter. In contrast, 58% of respondents from Big Pharma still said the regulatory situation was in decline. “The long-term damage to the FDA is just now starting to become apparent in review processes,” one respondent wrote. The most pessimistic group was scientists. When we asked a more forward-looking question — how the regulatory and policy climate would look a year from now — 40% of scientists expected conditions to continue to worsen, while only 12% predicted improvements. Comments on the regulatory environment in Q3 were far from glowing. The consensus was more a hope that things might begin to stabilize after a year of "regulatory chaos" that included FDA staff turnover, policy reversals and the unexpected freezing or termination of thousands of NIH research grants. Most of the grants have now been restored. The real test will be what approach the replacement leadership takes. Kyle Diamantas, the agency's former food chief, has run the FDA on an acting basis since May. Heidi Overton, Trump's pick for commissioner, is still waiting for the Senate HELP Committee to schedule a vote more than a month after her Sept. 24 confirmation hearing. And nothing's happening on that front at the moment because the Senate is out until Nov. 9, after the midterms. Read more from the Q3 2026 Biopharma Sentiment Index. if (!window.__epChartHeightListener) { window.__epChartHeightListener = true; window.addEventListener('message', function(e) { if (e.data && e.data) { var h = e.data.height; var frames = document.querySelectorAll('iframe'); for (var i = 0; i < frames.length; i++) { if (frames.contentWindow === e.source) { frames.style.height = h + 'px'; break; } } } }); }