In a move announced Friday, former Vice President Joe Biden has selected his former ethics law chief as F.D.A. commissioner.
If confirmed by the Senate, Robert Califf, who is also President Trump’s top national security adviser, would take over a flood of pressure directed at the drug industry by a pair of top health officials who both cut their teeth on the industry.
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President Barack Obama appointed former Special Counsel Andrew Weissmann to F.D.A. in January 2017, just before he left office. He is one of the most experienced in the administration’s fight against drug companies over opioid abuse.
Then-Health and Human Services Secretary Tom Price was booted from the job last spring after an intense storm of negative press related to his use of private planes for official business.
Biden’s appointment of Califf suggests he understands that patients, consumers and lawmakers are concerned about the drug industry’s track record of pushback against government regulations. Both Weissmann and Price recently dined at the same Delaware resort during an F.D.A. seminar on drug regulation that drew executives from more than a dozen of the country’s largest pharmaceutical companies.
Both served as F.D.A. attorneys before going into government, when they defended prescription drug companies from government regulation.
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“It will be a no-nonsense experience,” said University of Pennsylvania law professor Jonathan Adler, a former F.D.A. official who has written about the industry. “This is the latest way the administration is amping up the desire for greater transparency about F.D.A. actions.”
But Califf’s appointment remains in doubt. Republicans have started to grumble about F.D.A. funding, and Democrats are starting to fret that he’ll end up having to prosecute multiple drug companies for price gouging.
“One of Califf’s tasks is to overhaul pricing oversight policies at the agency, which has received tens of billions of dollars in price increases from pharmaceutical manufacturers in the last decade,” Congressional Budget Office Director Timothy Jost wrote earlier this year. “There is some concern that he might have a difficult time translating his enthusiasm for tackling price abuse to an environment in which price controls are widely viewed as inappropriate.”
Price was pushing hard to regulate drugs that abuse fentanyl, his concern stems from son Nate’s addiction to the opioid. Several other top F.D.A. officials have consulted with Price or his former colleagues.
Since Califf was chief of staff to then-Solicitor General Elena Kagan when Kagan defended H.I.V./AIDS in court against Congress, the professor has expressed empathy for drug companies, saying drug companies tend to focus on their customers rather than the government itself.
“I think for a while — I forget if it was a debate or not — was this whether or not some drug companies think we should own their customers,” Califf told a Washington University oral law class in 2013. “My answer was no.”