Califf Confirmed to Head FDA, Opposition Remains

By MedTech Intelligence Staff
February 29, 2016


• Categories: 05-Quality/Regulatory, Combination Products, RC - Medical Device Audits, Certification & Verification

Last week the Senate confirmed the appointment of Robert Califf, M.D., as the next FDA commissioner. The 89-4 vote, however, was not without outspoken opposition—and the most vocal opponents were Democrats who take issue with Califf’s ties to the pharmaceutical industry.

Bernie Sanders (D–VT) opposed the confirmation due to Califf’s salary history with Duke University, which was partially underwritten by Eli Lilly and Merk, according to The Washington Post. Sanders stated he didn’t think Califf would be able to “stand up to the greed of the pharmaceutical industry, one of the most powerful special interests in Washington.”

Democrats Edward J. Markey (Mass) and Joe Manchin III (W. Va) have been vocal about opioid abuse and the agency’s lax approach to the problem and stated that they will continue to fight the issue moving forward. “The fight I led against Dr. Califf was not personal. It was a fight to change the culture of the FDA starting from the top,” Manchin said in a statement.  “I still believe that we must act now to change the culture at the FDA if we have any hope of stopping the prescription drug abuse epidemic that is ravaging our nation.” Manchin added he was disappointed that someone outside of FDA was not brought in to lead the agency.

HHS secretary Sylvia M. Burwell commended the confirmation, stating “Dr. Califf is the right person with the right experience to build on the FDA’s unsurpassed record of protecting public health while encouraging innovation and the introduction of new life-saving therapies to the market… Dr. Califf’s life in medicine and research has positively impacted the lives of many Americans, and as the new head of the FDA, he will be able to improve the lives of many more.”