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Califf confirmed to lead FDA, but what’s next?


Some expect, or at least hope, the agency will be more nimble beyond the COVID-19 pandemic.

Robert Califf won his difficult confirmation battle and will lead the Food and Drug Administration, but now drug, healthcare, and other leaders are looking to see what he’ll do in the role.

The U.S. Senate confirmed Califf’s nomination Tuesday in a close 50-46 vote. President Joe Biden chose Califf as his nominee in November, citing his experience and expertise. He led the agency for a year under President Barack Obama. When he’s sworn in, Califf will succeed Janet Woodcock, who had been serving in an interim capacity.

However, some lawmakers were unhappy with his ties to the drug industry, and some said he allowed the opioid epidemic to spread widely under his previous stint at the FDA.

However, Califf is a known quantity, and many will undoubtedly be anxious to see how he leads the agency as he takes the reins again.

Barbara Binzak Blumenfeld, a healthcare attorney at Buchanan Ingersoll & Rooney, specializes in FDA-regulated product approvals. With the FDA lacking a permanent leader for a year, Blumenfeld said in a recent interview with Chief Healthcare Executive that many had wanted clarity on the agency’s future.

The FDA has moved more quickly than usual to approve drugs and therapies during the COVID-19 pandemic, and she said many will want to see that continue.

“The industry is going to expect that,” Blumenfeld said. “The industry pressure will be there.”

Some may not be satisfied with seeing the agency simply maintain some of the speed of COVID-era approvals. “They may say they want the FDA to move even quicker,” she said.

Still, Blumenfeld said the FDA deserves credit for getting COVID-19 vaccines approved faster than many thought possible.

“Getting vaccines authorized at the speed they did, I still think that was a monumental day for science and medicine, to be quite honest,” she said.

At the same time, some are pressing the FDA to move more quickly to approve COVID-19 vaccines for kids under the age of 5.

Califf will have to deal with supply chain issues, although Blumenfeld said many of those issues are beyond the agency’s control. She expects supply chain challenges to continue for the time being.

Other questions involve how the FDA will continue to monitor subjects in clinical studies, and if the agency will resume some inspections that have been slowed during the pandemic.

After the confirmation vote Tuesday, U.S. Sen. Elizabeth Warren, D-Mass., noted Califf’s commitment “to close the revolving door between government & the industries it regulates,” as she wrote on Twitter.

“We need strong @US_FDA leadership to help end the pandemic, strengthen public health & lower drug prices,” Warren said.

A cardiologist, Califf easily won confirmation to lead the FDA in the Obama administration, but it was a much tougher fight this time around.

Califf did secure votes from a handful of Senate Republicans, although a few Senate Democrats voted against his confirmation. U.S. Sen. Richard Burr, R-N.C., noted the opposition as he urged the Senate to confirm Califf.

“There’s been a lot of criticism as to what he’s done,” Burr said, adding much of it was unfounded.

“Dr. Califf is a supremely qualified nominee with bipartisan support,” Burr said on the Senate floor. “He has the robust agency and private sector experience needed to help build on the success of the FDA in helping Americans get back to normal life, with the approval of tests, vaccines and therapeutics that are bringing the pandemic to an end.”

“He’s the leader we need today, but also for the future.”

U.S. Sen. Joe Manchin, D-W. Va., bitterly opposed Califf’s nomination. Manchin and U.S. Sen. Mike Braun, R-Ind., wrote an opinion piece in USA Today arguing that Califf can’t stem a drug epidemic that he worsened in his previous FDA tenure.

“Given the dire situation facing our communities, it makes absolutely no sense to install a candidate who has already led the FDA in its most senior position but failed to address this crisis in any meaningful way,” they wrote. “We need new, dedicated leadership that understands the gravity of the drug epidemic and will fight back against the greed of the pharmaceutical industry.”

Sen. Bernie Sanders, I-Vt., voted against Califf’s confirmation. Sanders had assailed Califf’s ownership of stock in pharmaceutical companies.

Califf had been working recently as an adviser at Google Health and Verily and serves on the boards of Centessa Pharmaceuticals and pharmaceutical company Cytokinetics. He will resign those posts, CNBC reported.

With Califf winning confirmation, interest groups began pressing him on everything from vaccines to hearing aids. U.S. Rep. Raja Krishnamoorthi, D-Ill., urged Califf to protect children, particularly by banning flavored e-cigarettes.

“I have long pushed for the FDA to help curb the youth vaping epidemic,” Krishnamoorthi said in a statement. “This includes pushing for the agency to rule on all outstanding e-cigarette applications and ban all flavored e-cigarettes, including menthol-flavored e-cigarettes, which are targeting America’s children.”

Blumenfeld said the FDA’s new leader faces the challenge of managing the agency with lessons learned from the pandemic and continuing to move forward with a robust agenda.

“It’s almost taking double duty,” she said.

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