Biden FDA pick familiar to agency, drug industry
Nominee is former leader with Big Pharma ties
WASHINGTON — President Joe Biden announced Friday that he would nominate Dr. Robert Califf, a former commissioner of the Food and Drug Administration, to lead the agency again. His decision ends nearly a year of political wrangling as the White House vetted and then dropped several candidates after complaints that some were too close to the pharmaceutical industry.
In the end, White House officials might have concluded that they could not find a suitable candidate with no industry ties. Califf, 70, a respected academic and clinical trial researcher who ran the agency during the last year of the Obama administration, has long been a consultant to drug companies and ran a research center at Duke University that received some funding from the drug industry.
Since Margaret Hamburg, who served as commissioner for most of the
Obama administration, left in 2015, the FDA has had seven commissioners — some acting, some permanent — including Califf, who served for just 11 months after Hamburg’s departure. And recently, its reputation for independence has come under attack.
The FDA has been front and center in the federal government’s response to the coronavirus pandemic. It has the authority to approve COVID-19 vaccines, tests and treatments, as well as certain types of protective equipment. It was also widely criticized for allowing manufacturers to flood the market with inaccurate COVID-19 tests early in the pandemic and for failing to stand up to Biden’s predecessor, Donald Trump, who at times promoted unproven and unsafe treatments.
“Dr. Califf is one of the most experienced clinical trialists in the country, and has the experience and expertise to lead the Food and Drug Administration during a critical time in our nation’s fight to put an end to the coronavirus pandemic,” Biden said in a statement.
The statement added that Biden was confident that Califf would ensure that the FDA continued its science and data-driven decision-making.
During his previous stint as commissioner, Califf sought to permit pharmaceutical companies to advertise off-label uses for FDA-approved products, a practice that is not permitted under the strict regulations governing drug advertising. But the proposal, which many public health experts considered dangerous, was blocked by others in the Obama administration, according to a person familiar with it.
For the past two years, after stepping down as the vice chancellor for clinical and translational health at Duke, Califf has worked as a senior adviser to Verily Life Sciences, a health technology firm, and its sister company Google Health. He has encouraged Verily to focus on addiction, cardiovascular health and management of chronic diseases, according to a person at the company who spoke on the condition of anonymity.
Califf, who remains an adjunct professor of medicine at both Duke and Stanford universities, is on the corporate board of Cytokinetics, a biopharmaceutical company, according to its website. He has received personal fees for consulting from Merck, Amgen, Biogen, Genentech, Eli Lilly and Boehringer Ingelheim, according to his Duke University biography.
In a statement, Califf said he was honored to be nominated for the position “at a critical time for our country,” adding, “There’s a lot of work to do, and if confirmed I look forward to rejoining the great team at the FDA to help in their inspiring mission to serve the public.”
If Califf is confirmed by the Senate, he will again take the reins of an agency that is responsible for more than $2.8 trillion worth of food, medical products and tobacco. The FDA regulates products accounting for about 20 cents of every dollar spent by consumers in the United States.
More recently, the agency’s dealings with Biogen, the maker of a newly approved drug for Alzheimer’s disease, have come under scrutiny. The FDA approved the drug, Aduhelm, which costs $56,000 annually, over the objections of its own independent advisers, who said there was insufficient evidence that it was effective.
Dr. Janet Woodcock, the acting commissioner, was once considered a front-runner for the top job. But critics accused her of being too close to the pharmaceutical industry.
But others said they believed that Califf ’s industry experience should not bar him from the job, noting that he has disclosed his ties in publishing the results of clinical trials.
“The truth of the matter is, industry develops drugs; you have to work with industry. The issue is disclosure in publication,” said Ellen Sigal, founder and chair of the nonprofit Friends of Cancer Research, which accepts industry funding.