The post I think most about is FDA commish; there, my view is that any consulting for pharma/ device co should be disqualifying
In an interview last May, Dr. Marty Makary expressed reasonable concerns about people who left the FDA to work for industry. While noting that we live in a “free country”, Dr. Makary also worried about former FDA employees having “undue influence”. “When it comes to their influence on the operations of the FDA, that is something we cannot tolerate,” he said.
In another interview, Dr. Makary said that previous FDA commissioners, who doubted the still unproven claim the COVID vaccine killed 10 children, were “paid by big pharma” and therefore unreliable. Dr. Makary reported at a MAHA summit that in contrast to these unethical doctors, he has “taken a voluntary pledge never to work for Big Pharma for the rest of my life.” Good for him.
Dr. Makary’s right-hand man at the FDA, Dr. Vinay Prasad, has long expressed similar thoughts, writing:
- I am, like most Americans, sick of revolving doors & tweeps may know I have published on this topic You can’t take 400k from airbnb and 400k from carnival cruises and then shape policy that impacts their profits.
- The post I think most about is FDA commish; there, my view is that any consulting for pharma/ device co should be disqualifying, but most don’t agree with me, I concede.
- This is Bob Califf, current FDA commish. When not in office, he stuffs his pockets with pharma cash & takes roles in biotech that interface with FDA. When in office, he approves ineffective, costly drugs & lies about antivirals like Paxlovid. The current system is corrupt.
Those are harsh words, but these concerns are not misplaced, and every reasonable person supports a wall between pharma and FDA regulators. There is ample evidence that pharma money influences doctors, even though most of them incorrectly feel that they are immune to such forces. A wise mentor advised me to avoid pharma long ago, and despite receiving many tempting offers, I have made $788 from pharma since 2018, all but $150 in the form of office lunches I am too weak to resist. I think it is great that this data is freely available to anyone.
Makary is a director on the board at Harrow, an ophthalmic pharmaceuticals company
However, as SBM readers know, our current medical establishment has one set of standards for themselves and an entirely different, higher set of standards for everyone else. Dr. Prasad’s concern about a doctor who stuffs his pockets with pharma cash & takes roles in biotech that interface with FDA vanished immediately upon assuming office. He no longer feels that any consulting for pharma/device co should be disqualifying for the FDA commissioner.
Similarly, Dr. Makary’s concern about the revolving door was entirely unidirectional. He expressed no concern about people leaving industry for the FDA, even though this path has greater potential for malfeasance. In fact, Dr. Makary has facilitated such journeys. He appointed Dr. George Tidmarsh to head CDER, for example, boasting in the announcement that “Dr. Tidmarsh has led the successful clinical development of seven FDA-approved drugs and served as founder and CEO of multiple biopharmaceutical companies”. Dr. Tidmarsh’s brief tenure ended in disaster precisely because of this history- he allegedly abused his powers at the FDA to enact revenge on a former business partner.
Dr. Makary also conveniently never mentions his own pharma ties. According to one news report from 2024:
Makary is a director on the board at Harrow, an ophthalmic pharmaceuticals company, and an adviser to Sidecar Health, an insurance provider that aims to lower customer costs by eliminating provider networks and drug formularies. He’s also chief medical adviser to Nava, a benefits brokerage, and chief medical officer at Sesame, a cash-pay health service market that offers compounded semaglutide.
Despite being a pancreatic surgeon with no expertise in ophthalmic products, Dr. Makary earned a pretty penny from Harrow Health, garnering $130,357 in the two years prior to becoming FDA commissioner. That’s triple the amount Dr. Robert Califf received, which prompted Dr. Prasad to say he “stuffs his pockets with pharma cash” and the “current system is corrupt.”
Aldeyra Dry Eye Disease Candidate Hit by FDA Delay
I discussed Dr. Makary’s conflicts of interest when he was nominated in my article Questions for Senators to Ask Drs. Marty Makary and Jay Bhattacharya. That first question in that article asked, “why should the American people believe you’ll represent their interests over these corporations?” That remains a fair question, especially for anyone working for an openly corrupt President in an administration where blatant conflicts of interests are the norm. Indeed, now that Dr. Makary is FDA commissioner, regulatory standards are falling, leaders like Dr. Prasad have private meetings with investors, and the headlines read On Eve of JPM, Everything’s Coming Up Big Pharma. That article said:
From the corporate jets of Teterboro Airport to the crowded halls of the J.P. Morgan Healthcare Conference, it’s a good time to be a pharmaceutical executive.
After months of fear, anxiety, and frantic negotiation, the men and women who run the world’s largest drugmakers are striding into 2026 newly unencumbered as they descend on San Francisco next week for JPM, as it’s known. President Trump, who began his second term with sharp words and escalating demands for the industry to lower its prices, has become a vocal supporter. And thanks to a series of White House photo-ops, presidential handshakes, and agreements with drugmakers, the risk of destabilizing tariffs and painful pricing policies appears to be off the table, giving Big Pharma its warmest investor reception since the height of the Covid-19 pandemic.
Meanwhile, Dr. Makary is doing promotional infomercials at industry events for untested AI wellness devices.
Give all this, I couldn’t help but notice that other ophthalmic pharmaceutical companies are having trouble with the FDA today. According to the article US FDA Declines to Approve Outlook’s Eye Disease Drug for Second Time in 2025:
Outlook Therapeutics said on Wednesday the U.S. health regulator has declined to approve its drug for a type of eye disease, dealing another blow in the company’s prolonged push to bring the treatment to market and sending its shares tumbling nearly 70% after the bell…
The U.S. Food and Drug Administration had initially declined to approve the drug, also called bevacizumab, in 2023, in part due to manufacturing issues observed during pre-approval inspections.
It again declined to approve the drug in August 2025, citing a lack of substantial evidence of effectiveness, and recommended the company submit additional data to support the application.
Outlook said on Wednesday the FDA concluded that additional data provided with the resubmission did not change its prior view, and it again recommended confirmatory evidence of efficacy to support approval.
The FDA has not indicated what type of confirmatory evidence would be acceptable for Lytenava, which is approved in the European Union and the UK, the company said.
According to the article Aldeyra Dry Eye Disease Candidate Hit by FDA Delay Amid Shifting Agency Guidance:
The FDA has delayed an approval decision for Aldeyra Therapeutics’ lead dry eye disease candidate, adding another detour to the candidate’s winding road to potentially enter the market.
At a Dec. 12 meeting, the agency requested Aldeyra submit a report for a failed trial that the regulator had previously told the company not to include in reproxalap’s new drug application, Aldeyra CEO Todd Brady, M.D., Ph.D., explained during a Dec. 16 conference call…
The Office of Specialty Medicine (OSM) oversees the Division of Ophthalmology, and Brady said that Aldeyra has had no interaction with OSM or any other part of the FDA aside from the ophthalmology office. The request to submit a report on the failed trial to the NDA, which triggered the PDUFA delay, was made by the OSM, he explained.
Extensive layoffs and leadership flux at the FDA this year has prompted fears of disrupted drug reviews and the loss of American biotech leadership. Brady said Aldeyra has seen no turnover in the ophthalmology staff that they interact with. The only major change, he noted, is that the former director of OSM retired over the summer, with a new director taking over.
It was not immediately clear who the current director of OSM is—an FDA webpage last updated in 2020 lists Charles Ganley, M.D., as acting director. At the time of publication, the FDA had not answered questions from Fierce about leadership at OSM.
It’s likely there are reasonable explanations for all this, or that it is indicative of the broader dysfunction and chaos at the FDA. But it’s also possible the FDA commissioner is exerting “undue influence” to help his former benefactor and target their competitors. It’s not my fault for wondering about this. It’s Dr. Makary’s fault for excoriating doctors who get paid by big pharma with one hand, while getting paid by big pharma with the other.
