RE: Rob Califf -- CQ on the QT

  • by: |
  • 09/16/2015

Good story in Congressional Quarterly on President Obama’s nomination of Rob Califf to be the next FDA Commisisoner.

Unfortunately, since CQ is a subscription-only service, I can only provide some snippets:

Califf, according to several former FDA officials, is a believer in new technology and involving the voice of the patient in the drug development process.

"He understands what the future of health care looks like," said Peter Pitts, who led FDA external relations during the George W. Bush administration.

Califf previously was a top official at Duke University's School of Medicine. During a 30-year career at Duke, he was in charge of the Translational Medicine Institute, whose goal is to speed up the development, testing and approval of drugs and devices.

At the time of his appointment, the FDA hailed Califf, a cardiologist, as "one of the top 10 most cited medical authors." Shortly before taking his FDA position, Califf oversaw a vast long-term study that revealed that a cholesterol-lowering drug could help prevent heart attacks in some patients who cannot tolerate a more common cholesterol-reduction method, statins.

But during his years at Duke, Califf developed close ties to players in the pharmaceutical industry. Some believe these relationships will be an asset for someone who needs industry buy-in for his agency's policies. If Califf is confirmed, Pitts said, it "means the FDA can be both the regulator of industry and its colleague in innovation."

The Senate Health, Education, Labor and Pensions Committee would hold a hearing on Califf's nomination.Sen. Lamar Alexander, R-Tenn., the committee chairman, said in a statement that the panel will move promptly on the nomination.

"Dr. Califf has impressive credentials," said Alexander. "The FDA affects nearly every American and needs the certainty of a strong leader. I look forward to hearing from Dr. Califf specifically on how we can move medical discoveries more rapidly through the FDA and other agencies and get safe treatments and drugs into Americans' medicine cabinets."

If Califf is confirmed, he may only have a little more than a year on the job. But FDA observers say that he's already worked hard to earn a rapport with different branches of the agency and policymakers.

Former FDA official Frank Sasinowski, now a consultant, said Califf will be able to "go into congressional hearings and people will understand that he has an appreciation of what it takes to drive innovation and get new therapies out to patients."

If you are a CQ subscriber, the full article can he found here.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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