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Senate Health panel advances Califf to lead FDA

Nominee has bipartisan support, bipartisan opposition

FDA Commissioner Robert Califf will make the final decision on removing the only available drug aimed at lowering the risk of premature births.
FDA Commissioner Robert Califf will make the final decision on removing the only available drug aimed at lowering the risk of premature births. (Bill Clark/CQ Roll Call file photo)

The Senate Health, Education, Labor and Pensions Committee advanced Robert Califf’s nomination to be commissioner of the Food and Drug Administration in a 13-8 vote Thursday. 

“As our nation continues to fight the COVID-19 pandemic, the scientists and experts at the Food and Drug Administration who are working diligently to ensure we have safe and effective vaccines, tests, treatments, and more, deserve a strong leader who will make sure science always comes first,” Chair Patty Murray, D-Wash., said in a statement.

Califf had the top job at the FDA for one year in 2016, under the Obama administration, and was confirmed then in a bipartisan 89-4 vote. But in a more polarized Washington and with unprecedented scrutiny on the FDA, he faced a tense job interview with the committee on Dec. 14. 

Biden nominated Califf after a nearly yearlong search, underscoring the challenges Califf will face.

The former FDA commissioner, cardiologist and biotechnology consultant has done extensive research on clinical trial design. As part of this work, he has advocated incorporating electronic medical records into the data the FDA uses to determine whether a drug is safe and effective, a view that supporters say could lead to positive changes at the agency. 

But that work has also brought him into many partnerships with the pharmaceutical industry, and several senators have questioned his impartiality in FDA actions on drug approvals, especially in the context of the raging opioid crisis. 

Two committee senators with concerns about Califf’s ability to be a watchdog at the FDA, Sens. Bernie Sanders, I-Vt., and Maggie Hassan, D-N.H., joined Republicans to vote against his confirmation. 

Sens. Richard M. Burr, R-N.C., Mitt Romney, R-Utah, Susan Collins, R-Maine, and Lisa Murkowski, R-Alaska, who were complimentary of Califf’s deep experience with clinical trials during his confirmation hearing, joined Democrats to back the nominee. 

Califf would take the FDA reins amid profound uncertainty about the future of the pandemic. Rapid COVID-19 tests regulated by FDA are hard to find and expensive. New antiviral treatments that could stave off hospitalization are also in short supply, and some monoclonal antibody treatments do not protect against the omicron variant. 

The FDA faces a credibility crisis with millions of Americans who have yet to receive a first dose.

And the Health and Human Services Office of the Inspector General is investigating whether meetings between a top drug reviewer at the FDA and drugmaker Biogen about a controversial Alzheimer’s drug were inappropriate. The drug was approved on a fast-track pathway without demonstrating a clear clinical benefit.  

On Tuesday, the Centers for Medicare and Medicaid Services proposed stiff Medicare coverage limits on the drug, brand name Aduhelm, amid concerns the drug could bankrupt Medicare and state Medicaid programs.

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