May 12, 2026

Makary Resigns At FDA

Food and Drug Administration (FDA) Marty Makary, M.D, is out at the agency, having resigned under pressure from Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. The move was approved by the White House.

The last straw appeared to be Makary’s reluctance to approve fruit-flavored e-cigarettes given the potential for abuse by minors.

Critics argued that Makary lacked government experience and did not lead the agency well. Others say he rightfully pushed back on certain administration initiatives he deemed wrong-headed.

I won’t get into the saga, only to say that Makary was dealt a poor hand, with layoffs and huge cutbacks at a time of great political volatility for the agency. Such appointments don’t always work out for the principled person.

I am a supporter of Makary, who I have been connected with for over five years now. (He endorsed my book when it was published.) I was inspired to write based on several of his works and those of Uwe Reinhardt. Makary is a deep thinker and consummate professional. His works on surgery, healthcare, and reform are top-notch. He brings the unique perspective of a practicing physician and academic to healthcare reform. Makary would be better as a healthcare policy change agent more broadly.

That Makary drew scorn from all corners is likely a signal that he was actually a good pick. His speeding of drug development will be a lasting legacy as will his reforms on rare diseases. I know he will continue to influence the healthcare world for good.

Additional articles: https://www.fiercepharma.com/pharma/fda-commissioner-marty-makary-resigns-capping-turbulent-tenure and https://www.healthcaredive.com/news/makary-fda-commissioner-resign-trump/820008/ and https://www.medpagetoday.com/washington-watch/fdageneral/121232 and https://thehill.com/policy/healthcare/5875030-marty-makarys-tenure-as-head-of-fda-ends-with-difficulty/

(Some articles may require a subscription.)

#fda #makary #trump #hhs #rfkjr

https://www.modernhealthcare.com/politics-regulation/mh-trump-fda-marty-makary-resign

Democrats Continue To Do Well In Generic Ballots

A new poll shows a majority (54.6%) said they would support the Democratic candidate, while 40.1% indicated they would back the Republican candidate in the coming midterms. At the same time, a CNN poll shows Democrats winning by a tighter margin. Roughly 45% of Americans said they would support a Democrat, and 42% said they would support a Republican in the midterms.

#midterms #elections 

https://thehill.com/homenews/campaign/5873873-democrats-expand-lead-gop-midterm-poll/?tbref=hp

ACCESS Examined

Health Affairs Forefront blog reviews the ACCESS program as do CMS officials in the JAMA Network. In my view, ACCESS could be one of the most impactful of all Centers for Medicare and Medicaid Services’ value-based-care reforms.

Additional article: https://www.healthaffairs.org/content/forefront/access-model-may-set-off-health-tech-gold-rush-but-new-markets-bring-serious-obstacles

(Some articles may require a subscription.)

#access #cms #vbc

https://jamanetwork.com/journals/jama/fullarticle/2848799?guestAccessKey=b3681c01-430f-443f-9fb6-0f39855791cb&utm_source=linkedin_company&utm_medium=social_jama&utm_term=20462148984&utm_campaign=article_alert&linkId=941158510

— Marc S. Ryan

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