Califf confirmation could come as early as Tuesday

The five-month saga to confirm Dr. Robert Califf as the next head of the U.S. Food and Drug Administration might be coming to an end.

Senators by a 80-6 vote Monday approved a motion for cloture on Califf's nomination vote. That eliminates the risk of a filibuster that could have furthered delayed approval to confirm the next FDA commissioner.

A confirmation vote could come as early as Tuesday.

Califf, a prominent cardiologist and medical researcher at Duke University for more than 30 years, is now the No. 2 official at the FDA. In September, he was named the Obama administration's pick to succeed Dr. Margaret Hamburg as head of the agency.

Although he has received bipartisan support, several lawmakers have expressed concerns over Califf's ties with the drug industry as well as the FDA' s overall response to the opioid drug abuse epidemic.

Four senators had vowed to block his confirmation in an effort to force the agency to be tougher on prescription drug prices and the abuse of opioid painkillers. The opponents included Democratic presidential candidate Sen. Bernie Sanders and Democratic Sens. Joe Manchin of West Virginia and Ed Markey of Massachusetts.

Manchin and Markey held a news conference before the vote blaming the FDA for enabling the opioid crisis. In 2014, U.S. deaths linked to misuse and abuse of prescription painkillers climbed to 19,000, the highest number on record, according to the Centers for Disease Control and Prevention. By its estimation, deaths tied to these drugs have risen more than four-fold since 1999 amid increased prescribing by U.S. doctors.

"The FDA is part of the opioid problem when America is depending on it to be part of the solution," Markey said.

For years, the FDA has made only minor changes to the way it regulates painkillers like OxyContin and Percocet, despite the record levels of abuse and death tied to the highly addictive medications. Hamburg repeatedly stressed the need to keep prescription opioid drugs accessible to patients with chronic pain.

But in an unusual move as pressure mounted from the Senate, Califf announced earlier this month that the agency would rethink its approach. He pledged that the agency would add new warning labels to the most commonly prescribed opioids and require new opioid drugs to go before an outside panel of independent reviewers.

"It's time we all took a step back to look at what is working and what we need to change to impact this crisis," Califf said in a statement.

Manchin and Markey said it wasn't enough. They said that if Califf is confirmed, they will continue through other legislation to try and bring more attention to the problem.

Sanders did not leave the campaign trail to vote, but said in a statement released by his office that Califf is too tied to the pharmaceutical industry. In 2006, Califf founded the Duke University Clinical Research Institute, a contract research group that has conducted studies for virtually all of the world's largest drugmakers.

"We need someone who will work to substantially lower drug prices, implement rules to safely import brand-name drugs from Canada and hold companies accountable who defraud our government," Sanders said. "Dr. Califf's extensive ties to the pharmaceutical industry give me no reason to believe that he would make FDA work for ordinary Americans."

As head of the FDA, Califf would inherit a raft of projects and potential challenges, including unfinished tobacco regulations and food safety and labeling reforms.

Hamburg left the job early last year. The FDA's chief scientist, Dr. Stephen Ostroff, is serving as acting head of the agency.

The Associated Press contributed to this report.

Steven Ross Johnson

Steven Ross Johnson has been a staff reporter for Modern Healthcare magazine since 2013 and covers issues involving public health and other healthcare news. Johnson has been a freelance reporter for the Chicago Tribune, Progress Illinois, the Chicago Reporter and the Times of Northwest Indiana and a government affairs reporter for the Courier-News in Elgin, Ill. He received a bachelor's degree in communications from Columbia College in Chicago and a master’s degree in journalism from the Medill School of Journalism at Northwestern University.

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