The nomination for Dr. Robert Califf to lead the Food and Drug Administration narrowly advanced out of the Senate Health Committee on Thursday by a vote of 13 to eight largely along party lines.
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Six Republicans, plus a Democrat and an independent who caucuses with the Democrats — New Hampshire’s Maggie Hassan and Vermont’s Bernie Sanders — opposed Califf’s nomination for FDA chief, signaling outstanding concerns on both sides of the aisle about his financial ties to the pharmaceutical industry, the FDA’s history of approving opioid medications despite the health risks, and policies for regulating abortion.
Sanders said ahead of the vote, “We need leadership at the FDA that is finally willing to stand up to the greed and power of the pharmaceutical industry. … Shockingly, nine out of the last ten FDA Commissioners went on to work for the pharmaceutical industry or to serve on a prescription drug company’s board of directors. Unfortunately, Dr. Califf is not the exception to that rule.”
Hassan, meanwhile, rejected Califf’s nomination out of concern that the agency under his leadership would not keep doctors from overprescribing opioids, which are rampant in her home state.
“New Hampshire has been hit especially hard by the substance misuse epidemic and it is imperative that we have a strong FDA Commissioner in place who recognizes the role that the agency’s decisions played in fueling this crisis,” Hassan said. “After careful review of Dr. Califf’s record … it does not appear that things would be different under his leadership.”
Califf, a cardiologist, has had a long career in medical research at Duke University and is one of the most frequently cited authors in biomedical science, with over 1,200 peer-reviewed publications. He was paid as a consultant for pharmaceutical companies, including Merck, Johnson & Johnson, and GlaxoSmithKline from 2009 to 2013. He also was chosen by former President Barack Obama to serve as FDA commissioner from 2016 to 2017 before becoming the head of medical strategy and policy at Verily, Google’s health sciences arm.
West Virginia Sen. Joe Manchin, a centrist Democrat who has been under fire for voting against his party’s objectives, has already said that he will vote against Califf’s nomination over his ties to the pharmaceutical industry when it gets to the Senate floor.
The date for a full Senate vote has not yet been announced, but lawmakers are eager to get a permanent FDA head in office after about a year without one.
“We need a wartime Commissioner, who will lead us through the next phase of the response to coronavirus, and build a stronger, more nimble FDA,” Senate Health Committee ranking member Richard Burr, a Republican, said last month. “The past two years have tested FDA. Its authorities and regulatory practices have come under scrutiny as the gatekeeper for medical countermeasures needed to protect against the coronavirus.”
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Republican lawmakers, for their part, are basing their opposition to Califf’s confirmation over abortion access. For instance, a spokesperson for Kansas Republican Sen. Roger Marshall confirmed that his “no” vote was over abortion rights issues. Last month, the FDA permanently lifted prescribing restrictions on abortion-inducing medication, a regimen of two pills that can be taken within the first 10 weeks to terminate a pregnancy. Under the new prescribing guidelines, which were first loosened during the pandemic to limit exposure to the virus in doctors offices and waiting rooms, the abortion medication can be prescribed via telehealth services and sent to patients through the mail.
Anti-abortion rights groups have rallied around the medication abortion issue in recent months while the Supreme Court mulls over a Mississippi case that puts legal access to the procedure in jeopardy.
“With a track record of rubber-stamping abortion industry demands and with permanent authorization of unsafe mail-order abortion hanging in the balance, Califf is the wrong choice for FDA Commissioner. We urge you to vote no on his nomination,” said Marjorie Dannenfelser, president of the anti-abortion group Susan B. Anthony List.
