At the Senate hearing on Tuesday, President Joe Biden chose to lead the Food and Drug Administration, avoiding various crises from the COVID-19 pandemic to the opioid epidemic, which seemed to augur well for his confirmation.
After the hearing, independent Senator Bernie Sanders of Vermont announced that he would oppose the nomination of Dr. Robert Calif. But Senator Patty Murray (Patty Murray, D-Wash.), chairman of health, education, labor, and pensions, and Richard Burr, the Republican ranking senator, both said they would support him.
Califf, who briefly served as the FDA commissioner at the end of the Obama administration, promised that if confirmed, he will use the data to simplify the approval of COVID treatment and testing, conduct a comprehensive review of the FDA’s controversial treatment of opioid painkillers, and continue to pay attention Tobacco regulation, efforts to make prescription drugs cheaper, and to deal with medical misinformation on social media.
As a cardiologist with close ties to the pharmaceutical industry and academic research centers, Califf insists that public service is his motivation to return to the FDA. While laughing at himself, he called himself “a 70-year-old man with nothing.”
His most acute question came from Sanders, who emphasized Calif’s connection with pharmaceutical companies and his multi-million dollar investment in pharmaceutical stocks. “What comfort can you give the American people when you yourself are so closely connected with the pharmaceutical industry?” Sanders asked.
Kalif replied: “I fully support you. The price of medicines in this country is too high.”
New Hampshire Democratic Senator Maggie Hassan pressured Califf to change the FDA’s prescription information for opioids to better reflect the risk of addiction.
Senator Bill Cassidy, Republican of Louisiana, told the nominee, “I thank you for your vision.”
Although a series of scientific controversies-including the approval of a controversial Alzheimer’s drug-have damaged its public reputation, the FDA has been nervous amid the massive pandemic workload for months. Biden’s nomination of Calif last month was seen as a safe and stable choice to guide the agency, which has not had a permanent leader since January last year.
The FDA regulates vaccines, drugs, and tests used to fight COVID-19. This is the normal duty of overseeing a range of consumer products and pharmaceuticals, including prescription drugs, medical devices, tobacco and e-cigarette products.
More than a year after approving the first COVID-19 vaccine, the FDA still faces a series of key decisions, including whether to expand the booster injection to adolescents and children. In addition, as researchers learn more about omicron variants, the FDA will play a decisive role in whether injections should be updated to target strains.
FDA commissioners usually do not participate in daily scientific reviews, but they are the intermediaries between the agency’s scientists and White House political decision makers.
This fall, this relationship reached its peak when two top FDA vaccine examiners publicly opposed the Biden administration’s plan to provide boosters to all American adults. Both retired from the agency after decades of professional careers, which gave Califf the opportunity to choose a key replacement. Last month, as COVID-19 cases surged again, the FDA finally approved boosters for all adults.
Calif will also help select a new head for the FDA’s Tobacco Center, which is weighing whether to ban Juul and other e-cigarette companies’ e-cigarettes because of the risks of e-cigarettes to teenagers.
After working at Duke University for more than 35 years, Khalif served as an FDA commissioner for the first time, where he founded a contract research organization to conduct research for many of the world’s largest pharmaceutical manufacturers.
After leaving the government, he has served as Google’s health policy consultant, and has served as a board director or consultant for more than six pharmaceutical and biotechnology companies. According to the most recent Federal Disclosure Form, if confirmed, Califf will resign from all these positions.
In 2016, under the leadership of Califf, the FDA added an enhanced warning to prescription opioids and began a public review of all new opioid applications. But the agency has not implemented many other steps recommended by experts, including a comprehensive review of whether opioid painkillers pose more risks than benefits to society as a whole.