New FDA Chief Nears Confirmation With Crucial Senate Vote

  • Senators agree to end debate, make final decision on Califf
  • Appointment was held up over issue of opioid abuse epidemic

The U.S. Senate agreed to end debate on President Barack Obama’s nominee to lead the Food and Drug Administration, setting the stage for confirmation as early as Tuesday of former Duke University researcher Robert Califf as the agency’s commissioner.

The Senate voted 80-6 on Monday in favor of moving to a vote on passage of Califf’s nomination, despite some senators’ opposition, based on claims that the FDA hasn’t done enough to curb the opioid abuse epidemic in the U.S. Close to 20,000 Americans died in 2014 from overdoses on opioid prescription painkillers, which include drugs like OxyContin, according to the National Institutes of Health.

“This is an epidemic that’s devastating our entire country,” Senator Joe Manchin, a West Virginia Democrat, said on the Senate floor before the vote. “Rich or poor it makes no difference.”

Manchin said that Califf is “a qualified man” but “I just think he’s the wrong person at this time of need, for the position that we need, to shake it up. The commissioner of the agency must be someone willing to lead in a different direction.”

Manchin voted against ending debate on Califf as did Senators Ed Markey, a Democrat from Massachusetts; Kelly Ayotte, a Republican from New Hampshire; Richard Blumenthal, a Democrat from Connecticut; Bill Nelson, a Democrat from Florida; and Rob Portman, a Republican from Ohio.

Senators have focused on the FDA’s decision last year to allow OxyContin to be prescribed to children from 11 to 16 years old, which the FDA has said it did to give physicians guidance on safely prescribing the drug since they already were doing so anyway. The FDA also has taken heat for approving in 2014 a potent pure hydrocodone pill called Zohydro that wasn’t made with technology that could deter abusers from snorting or injecting the drug.

Opioid Plan

The FDA released an action plan on opioids earlier this month to address some of the opposition’s concerns. The agency said it would convene a panel of outside experts to advise it every time an application for an opioid not made with abuse-deterrent technology came up for review. It also would craft guidance to help generic drugmakers gain approval of abuse-deterrent painkillers to expand access to the drugs.

The FDA’s science board will meet March 1 to discuss the role of opioids in pain management and the scientific challenges in supporting the development of abuse-deterrent opioids, Sarah Peddicord, a spokeswoman for the FDA, said in an e-mail. It also will hold two meetings, one in April and the other in September, with a pediatric advisory committee on the use of the drugs in children in pain, she said.

While opioids have been the hot-button FDA topic, the agency has some other high-profile regulatory actions coming up, including extending its oversight of tobacco to electronic cigarettes and requiring food labels to disclose the amount of added sugar in a product. The FDA also is working to modernize food safety rules meant to curtail food-borne illnesses and is improving its ability to approve generic drugs more quickly as well as figuring out the details of regulating a new type of drug called biosimilars, which are less expensive copies of biologic drugs.

Sanders Opposed

Senator Bernie Sanders, an Independent from Vermont who’s running for the Democratic presidential nomination, has opposed Califf because he says the nominee has close ties to the pharmaceutical industry and wants him to commit to do more to bring down drug prices. The FDA isn’t allowed to consider pricing when reviewing or approving a medicine. Sanders was not present for the vote.

Califf led the key clinical trial evaluating Johnson & Johnson’s blood thinner Xarelto, which the FDA approved in 2011 to prevent strokes in people with an irregular heartbeat. Xarelto generated $1.87 billion in sales last year, according to data compiled by Bloomberg.

Obama nominated Califf for the position in September after Margaret Hamburg stepped down in March 2015. Stephen Ostroff, the agency’s chief scientist, has served as acting commissioner in the interim.

Califf was appointed deputy FDA commissioner for medical products and tobacco in January 2015. Before that, he was founding director of Duke’s Clinical Research Institute, the world’s largest academic research organization, the FDA said. He also led the university’s efforts on translational research, or turning basic scientific discoveries into new treatments for patients.

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