Califf Breezes Through Nomination Hearing for FDA Chief

Alicia Ault

November 18, 2015

WASHINGTON — Most members of a Senate committee had few reservations yesterday about Robert Califf's qualifications to be the next commissioner of the US Food and Drug Administration (FDA).

"You come here today with impressive qualifications," said Senate Health, Education, Labor and Pensions Committee (HELP) Chairman Lamar Alexander (R-Tenn), who clearly was a fan, as were many other Republican members of the panel.

Questions about Dr Califf's ties to the pharmaceutical industry, however, have dogged him since President Obama nominated him in September to lead the FDA.

Trying to head off those concerns, Chairman Alexander noted at the outset of the hearing that Dr Califf had gone through an extensive vetting process that involved the White House, the FBI, the Office of Government Ethics, and dozens of pages of questions from the HELP committee.

The staff "has not found anything that would call into doubt your ability to lead the FDA fairly and impartially," said Sen. Alexander.

But Sen. Elizabeth Warren (D-Mass) confronted Dr Califf directly about his past relationships with drug companies. "It's no secret that during your time at Duke University you received significant financial support from the pharmaceutical industry both personally and through your research," she said.

She asked him whether he believed that the FDA should lower its standards for approval.

"I've never been a proponent of lowering standards," said Dr Califf. "If anything, I've argued for raising standards."

Drug Prices an Issue

A cardiologist by training, Dr Califf, 64, has been deputy commissioner for medical products and tobacco at the FDA since January, leaving behind his position as vice chancellor of clinical and translational research at Duke University.

Most members of the HELP committee — especially Republicans ― were complimentary about Dr Califf's credentials. Sen. Bernie Sanders (D-Vermont), however, joined Sen. Warren in questioning Dr Califf's ability to lead the agency free of conflict.

Sen. Sanders has said previously that he would not support Dr Califf. Taking time off from the campaign trail, the Democratic presidential contender repeated his vow to vote against confirmation. Sen. Sanders said that Dr Califf would not address the rising cost of prescription drugs and quizzed him on why Americans paid among the highest prices for pharmaceuticals.

"I'm not an expert on the price of drugs," said Dr Califf, who noted that the Obama Administration did support price negotiation for Medicare in certain circumstances.

Sen. Sanders was not satisfied. "I believe we need a commissioner who's going to stand up to the pharmaceutical industry and protect American consumers," he said, adding, "You are not that person."

Dr Califf also was queried by several panel members on why the FDA seemed to be slow to approve generic drugs and update labeling requirements. The Generic Pharmaceutical Association estimates that approvals have gone from taking 30 months in 2011 to 40 months in 2014, Sen. Alexander said, adding that generics could help bring down the cost of pharmaceuticals.

The panel quizzed Dr Califf on many other topics, including Plan B, whether he would work to expedite approval of new sunscreen products, and when the agency would issue new advice on what types of seafood were safe for pregnant women. Several members also expressed frustration about the agency issuing lots of nonbinding guidance documents and fewer rules.

He said he would work with Congress to address its concerns.

Dr Califf has received support from hundreds of organizations. In early November, 50 health groups, including the American Society of Clinical Oncology, the National Alliance on Mental Illness, and the Society for Women's Health Research, among others, wrote to the Senate committee urging approval.

The HELP committee is expected to vote on Dr Califf's confirmation at a later date, some time after it closes its docket on Nov 24, a committee spokesman told Medscape Medical News.

Dr Califf's nomination would then go to the full Senate for a vote.


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