Former Vice President Joe Biden on Friday nominated Robert M. Califf to lead the Food and Drug Administration, despite a record of rulings that strained the agency’s relationship with major drug makers and lawmakers.
Mr. Biden issued the nomination, which requires Senate confirmation, hours after Dr. Califf resigned from his job as the head of the University of North Carolina’s Outcomes Research Institute, at which he had served since 2014.
At the end of each year, universities, public health organizations and other groups provide FDA information on the progress of their research. In 2016, the agency, which is part of the Department of Health and Human Services, published a report on preventive strategies, which included cost-effective strategies and strategies that fell more onerous.
Almost all of the targeted costs are related to opioid addiction and overdose deaths. The reports sparked criticism from the drug industry, which said that the numbers were “confused and dramatic.” The industry frequently used what is known as a “tailoring filter” to show which costs were related to abuse and which ones were devoted to studying the effects of using opioids.
“The vast majority of these expenses went toward documenting the basic effects of the drugs, rather than examining the actual effects of the drugs,” the drugs industry said.
Dr. Califf oversaw the implementation of the “tailoring filter,” and told a House committee last year that the report was “carefully crafted” and said the agency “is well positioned to act proactively in the current opioid abuse epidemic.”
A Califf nomination had been seen as a potential step toward strengthening the FDA’s relations with drug companies.
Dr. Califf has represented Merck Pharmaceuticals in a number of on-going legal battles, including cases stemming from a number of its vaccines.
In one case, he was the co-lead counsel for Merck Pharmaceuticals. In another, he was the lead counsel for World Health Organization.
Dr. Califf said he would recuse himself from all matters related to Merck in his new role at the agency.
Dr. Califf’s appointment to the FDA has been widely expected. Richard Pazdur, the acting commissioner, had previously said he thought the agency needed someone “of a bipartisan background,” which meant that an Obama appointee had to be named. At the time, Dr. Pazdur said he was unable to say whether that meant Dr. Califf would be considered for the permanent position.
More than a dozen drug and drug-related companies offered early endorsements for Dr. Califf. GlaxoSmithKline, the drug-maker, said he “knows the challenges FDA faces in fostering innovation and combating modern-day threats to public health.” Pfizer added, “We look forward to working with him, or anyone else selected to lead FDA, to ensure continued progress in drug approval and public health protection.”
Dr. Califf previously served as a senior official at the National Institutes of Health. In that role, he led a team that proposed several changes to institute that included more public input, more broad-based reviews and more influential oversight by federal judges and expert groups.
In a statement, Mr. Biden said, “All Americans have been affected by the opioid crisis and it is imperative that we urgently address this epidemic by building on the safety foundation established by the new FDA Commissioner. I have been impressed by Robert’s understanding of the issues faced by the FDA and innovative ideas about how to improve the agency.”
The nomination will face an uphill battle in the Senate.
Several Republicans have said the agency has been too close to the drug industry, despite its high-profile criticisms of the industry.
In a statement, Senator John Thune, a South Dakota Republican, pointed to areas where Dr. Califf and the FDA had failed to protect public health.
“The FDA has made progress to protect public health and patients and we remain concerned about the gaps in their efforts,” Mr. Thune said. “Given Dr. Califf’s administrative record and understanding of the FDA’s role in the FDA, I believe it is in the best interest of patients, especially those struggling with addiction, that he step up to serve at the FDA.”