R

epublicans lawmakers rarely give a warm reception to presidential nominees when a Democrat is in the White House. But President Barack Obama likely has little reason to worry about Tuesday’s confirmation hearing for Dr. Robert Califf, his choice to head the Food and Drug Administration.

If Califf faces any serious grilling, it’s likely to come from Democrats who have questioned his ties to the pharmaceutical industry and the relationship between drug makers and the Duke Clinical Research Institute, where he served as founding director.

Aside from Vermont Senator Bernie Sanders, who has vowed to reject Califf’s nomination, the toughest questions could come from Democrats Patty Murray of Washington; Edward Markey and Elizabeth Warren of Massachusetts; and Tammy Baldwin of Wisconsin.

advertisement

Here’s what to look for during Califf’s confirmation hearing before the Senate Committee on Health, Education, Labor and Pensions.

How would Califf speed up the approval of drugs?

The pharmaceutical industry has dispatched more than 1,300 lobbyists to the Capitol this year, and most of them are working toward one goal — making the process of getting their products through the FDA and onto the market faster and cheaper.

They came a step closer in July, when the House of Representatives overwhelmingly passed the 21st Century Cures Act, which would do just that. But the bill faces obstacles in the Senate.

Much depends on the FDA’s willingness to go along with this agenda, especially if Congress doesn’t pass a law directing the agency to simplify the approval process. Some within FDA believe speeding drug and device approval would undermine safety.

An appearance of coziness with industry

Look for Sanders and some other lawmakers to interrogate Califf on his ties to many of the pharmaceutical companies that the FDA regulates. Califf joined the agency in February after many years at Duke, where he founded the nation’s largest academic clinical research center. That center receives more than 60 percent of its funding from drug companies. Califf, a cardiologist, has also reported that pharmaceutical firms Eli Lilly, Merck, Novartis, and others contributed to his salary.

Last month, Sanders made clear he would not accept Califf’s nomination. “At a time when millions of Americans cannot afford to purchase the prescription drugs they need, we need a new leader at the FDA who is prepared to stand up to the pharmaceutical companies and work to substantially lower drug prices,” he said. “Unfortunately, I have come to the conclusion that Dr. Califf is not that person.”

Invoking Martin Shkreli

Senators from both parties are likely to press Califf on how he would keep drug prices from continuing to rise. Expect the name Martin Shkreli to be cited early and often. He’s the founder and CEO of the pharmaceutical company Turing, which recently raised the price of Daraprim, a drug often used to treat infections in people with AIDS, from $13.50 to $750 a pop.

The committee is also likely to ask Califf how FDA will prevent drug shortages, which can lead to price hikes.

Examining his record

Califf’s supporters note that he has had a stellar career as a researcher and has published many influential papers. Recently a host of patient advocacy groups and other medical associations — among them the American Academy of Pediatrics, Michael Milken’s FasterCures, and the National Alliance on Mental Illness — wrote to the Senate to support his nomination.

But critics, among them the Project on Government Oversight, a research and advocacy group, have raised questions about his clinical trial expertise. POGO noted that Califf played a key role in the Duke drug trial of Xarelto, a blood thinner. According to POGO, Califf pushed the FDA to approve it over the objections of its agency reviewers.

Missing attribution

Califf recently coauthored a series of scientific papers raising concerns about the agency’s oversight of clinical trials. But, as reported previously by STAT, he asked that his name be removed before publication. He hasn’t yet explained his reasons for doing so.

Leave a Comment

Please enter your name.
Please enter a comment.

Sign up for our Morning Rounds newsletter

Your daily dose of news in health and medicine.