Robert Califf, a cardiologist and President Biden’s “new” nominee to head the federal Food and Drug Administration, is a familiar face around the agency and Washington, D.C.
Califf served as the FDA commissioner before — winning U.S. Senate confirmation and holding the important post for the last year of the Obama presidency.
He is 70 and has long history in academic medical research and running clinical trials, including consulting for Big Pharma and giving his foes queasiness about his ability to run the nation’s top overseer of prescription medications and medical devices, as well as food quality and safety.
Senators, including Democrats Joe Manchin, of West Virginia, Edward J. Markey, of Massachusetts, and Richard Blumenthal, of Connecticut opposed his nomination before, with Manchin and Blumenthal saying they would do so again.
Califf overcame previous objections to his heading the FDA, partly because the record has been plain and clear about conflicts he may have and how he dealt with these. But he also satisfied Democrats that he would lead the agency in appropriate and acceptable ways to them, and Republicans — including now Senate Minority Leader Mitch McConnell — have supported him because they fretted they might be presented a more anti-industry pick.
Given how the GOP has slow-walked Biden nominees, Califf may be further constrained in any efforts to make big — and needed — changes at the FDA due to the ticking clock on his time as commissioner. He was nominated on the brink of a statutory deadline for filling the top FDA job and may not get into his official role until some time in the second year of Biden’s term. That leaves him with a small span to tackle big problems, especially as many agencies tread lightly in the last year of a presidential term, fearing to cause problems for a campaigning leader.
He is credited with getting some important work done in his previous, brief stint, including initiatives to deal with the opioid painkiller abuse and drug overdose crisis and in planning to shut down e-cigarettes and vaping. Scott Gottlieb, his GOP successor, reversed the FDA crackdown on alternative nicotine delivery systems, leading to a mess with young people, smoking, and vaping.
Janet Woodcock, an FDA stalwart and once considered a top, potential nominee as commissioner, will keep running the agency until a nominee is confirmed and takes office. Her candidacy, analysts say, was doomed by her work on drug regulation and senators blaming her and the FDA for its failures in better dealing with the opioid crisis, which federal officials say has killed more than 500,000 Americans in a decade and has worsened since the onset of the coronavirus pandemic.
Approval for Alzheimer’s drug has more blowback
Woodcock also took fire for what critics say have been bungles by the agency in giving controversial approval to Aduhelm, an evidence-light and costly prescription medication targeted for Alzheimer’s treatment, as well as the FDA blessing for the first time a vaping device as an anti-cigarette smoking alternative.
Seniors soon will feel the harms of the FDA’s Aduhelm decision, which was blasted by experts in the disease, including independent authorities advising the agency. Officials at the Centers of Medicare and Medicaid Services say that Medicare Part B rates will make one of their largest increases ever — by $21.60 a month in 2022 — in part because the federal government may be stuck paying for patients taking Aduhelm, even though its best-case benefits may be spare. Biogen has priced Aduhelm treatment at $56,000 annually.
Califf, who has spent much of his career at Duke Medical School and is credited with founding and building the Duke Clinical Research Institute into one of the largest academic clinical trial operations in the world, has criticized the way many clinical trials are conducted and how the FDA uses data from them as it oversees and approves prescription drugs.
He has called for improved use of technology to share, analyze, and apply data, and he has built ties — potentially problematic to those worried about the rise of Silicon Valley and its sway — in high tech, serving as a health policy advisor to Google’s parent company Alphabet.
He has his work cut out for him at the FDA, which is just one of the many federal agencies tasked with protecting the public health and which was politicized and damaged, notably during the anti-science administration of President Trump. Critics have slammed the FDA, saying it has not only become too dependent on industry for information and funding that it lacks the independence it needs as a reliable regulator. The agency has found itself, too, in the midst of ferocious debates over vaccines and medications for treating the coronavirus, with too many meds debunked yet promoted by extremists with little or no evidence.
U.S. health agencies struggle
Though optimism had prevailed about Rochelle Walensky, her brilliant achievements in academic and clinical medicine, and her much-promoted communication capacities, Stat, a science and medical new site, is reporting that she is faltering as Biden’s head of the federal Centers for Disease Control and Prevention. The CDC also was run aground during the previous administration.
The Washington Post reported that Biden at this point in his term has lagged other recent presidents in filling key posts in federal health agencies. Compensation apparently is playing a role in the administration’s ability to recruit top candidates who easily can find much higher paying posts in lucrative health care. Able individuals also may be wary of taking on public roles at a time when doctors, nurses, and frontline medical personnel, not to mention health policy makers, routinely get pilloried and threatened by those with extreme views.
In my practice, I see not only the harms that patients suffer while seeking medical services, but also the damage that can be inflicted on them dangerous drugs and by defective and risky products, particularly those of the medical kind. Patients are simply getting slammed by modern medicine’s complexity, uncertainty, and soaring cost — especially for therapies and prescription drugs.
With Big Pharma, medical device makers, and Big Agriculture lining up with deep pockets and tons of hired guns, who will represent the interests of regular folks, cutting through difficult scientific issues to safeguard patients and consumers? Taxpayers spend billions of dollars, wanting rigorous, independent experts from agencies like the FDA and CDC to protect them and be their prime advocates.
We’ve got a lot of work to do to see this happens — and here’s hoping that Califf, Walensky, and others in this administration don’t disappoint a wanting public.