The FDA’s new boss has pretty close ties to the industry he’ll regulate | McClatchy Washington Bureau

After five months of delays, the Senate voted 89-4 on Wednesday to confirm cardiologist Dr. Robert Califf, a longtime Duke University drug trial researcher, as the new commissioner of the Food and Drug Administration.

The Columbia, S.C., native was nominated to the post by President Barack Obama last September, but concerns about his ties to the pharmaceutical industry and some of the FDA’s practices tied up his confirmation.

“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,” Health and Human Services Secretary Sylvia Burwell said in a statement on Wednesday.

The position has been open since Dr. Margaret Hamburg stepped down last February. Califf already was serving as deputy commissioner of the agency, its No. 2 spot, when he was nominated last year.

“The broad bipartisan support for Dr. Califf’s nomination is testament to his strong, transparent leadership and record of advancing medical breakthroughs,” Sen. Lindsey Graham, R-S.C., said Wednesday in a statement.

“The FDA has been operating without a confirmed commissioner for the past year, and I applaud the Senate’s confirmation of Dr. Califf,” Graham said.

Several senators held up the confirmation over concerns ranging from the FDA’s approval and labeling processes to doubts about the candidate’s ties to the drug industry.

Califf spent three decades as a drug trial researcher at Duke University, where he founded Duke’s Clinical Research Institute. He forged close relationships with the pharmaceutical industry that some critics say are too close for comfort. Opponents to his confirmation have pointed out that as head of the agency, Califf would be in charge of regulating former clients.

The strongest pushback against Califf’s nomination came from Sen. Edward Markey, D-Mass., and Sen. Joe Manchin, D-W.Va., who said the candidate’s industry ties make him a poor choice to reform problematic practices in the agency. They expressed frustration with the FDA’s approval of pediatric opioids and said the agency needs to change its process for approving opioid painkillers.

Markey pointed out that 80 percent of heroin overdoses in 2014 happened to people who started out on prescription opioids.

“The FDA is not using the proper safeguards to make sure the problem doesn’t get worse,” Markey told fellow senators on Monday. “We consume 80 percent of all prescription opioid pills in the world. A pandemic has broken out.”

Sen. Lisa Murkowski, R-Alaska, also briefly held up the nomination in January because she wanted the agency to put labeling requirements in place for genetically engineered salmon.

Others, like Vermont Sen. Bernie Sanders, objected to Califf himself.

“His extensive ties to the pharmaceutical industry give me no reason to believe that he would make the FDA work for ordinary Americans, rather than pharmaceutical CEOs who are more focused on making obscene profits than saving lives,” Sanders, who is also a candidate for the Democratic presidential nomination, said last month in a statement.

Even so, Califf has broad bipartisan support in Congress and sailed through an initial vote by the Senate health committee last month. The Senate cleared the way for Califf’s nomination on Monday, overwhelmingly backing a motion to prevent lawmakers from further blocking the vote and limiting the debate on the decision to 30 hours. Only six senators voted against it, though some advocacy groups still tried to rally opposition to the nomination ahead of Wednesday’s vote.

“We need a strong watchdog willing to stand up to Big Pharma and crack down on exorbitant prescription drug prices, not an industry insider with extensive ties to the very companies he’s supposed to oversee,” said Murshed Zaheed, political director at liberal advocacy group CREDO Action. “We can only hope Dr. Califf will fight for American families instead of protecting the profits of the pharmaceutical industry.”

As of Wednesday, more than 190,000 people had signed a petition on the group’s website asking the Senate to oppose Califf’s nomination.

Supporters, public health groups and former colleagues applauded the final vote on Califf’s nomination on Wednesday.

“It’s a proud day for the DCRI and Duke,” said the executive director of Califf’s former institute, Dr. Eric Peterson, in a statement. “So many of us have had the privilege to work side by side with Dr. Califf through the years, and today marks another milestone in his storied career as a champion for improving patient care around the world. Dr. Califf has devoted his life to innovations in clinical research, and we look forward to his contribution to advancing and protecting our nation’s public health.”

As the new chief of the FDA, Califf is inheriting an agency that faces a slate of challenges in the final year of the Obama administration. Under his leadership, the agency will continue to be under pressure to speed the drug-approval process and to extend its regulation of tobacco to include electronic cigarettes.

The FDA also is in the middle of overhauling how it controls companies’ food-safety practices in order to prevent food-borne illnesses, and under pressure to end delays on labeling cheaper copies of biologic drugs, known as biosimilars.