Markey opposes FDA nominee because of stance on opioids

US Senator Edward Markey, a Massachusetts Democrat, spoke during a news conference.
Alex Brandon/Associated Press
US Senator Edward Markey, a Massachusetts Democrat, spoke during a news conference.

WASHINGTON — The Senate voted Monday to move toward final confirmation of a new Food and Drug Administration commissioner, brushing aside objections from Democrat Edward Markey of Massachusetts who opposed the appointment over FDA approvals of prescription opioids.

The motion easily cleared the required 60-vote threshold, passing 80-to-6. The bipartisan support set up a vote Tuesday to confirm for Dr. Robert Califf, a former Duke University researcher selected by President Obama to lead the agency.

Markey had placed a procedural “hold’’ last month on Califf in a bid to force the FDA to get tougher on addictive painkillers.


“Today we have an epidemic in the United States,’’ Markey said on the Senate floor, lamenting what he considers weak regulatory efforts by the FDA of Oxycontin, Percocet, and other addictive painkillers. “They are not going to change business as usual at the FDA ... with regards to what the industry has been doing to our country.’’

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Califf, a cardiologist, joined the FDA as a deputy commissioner in February 2015 after working on his own clinical research and in leadership roles at Duke University.

It was these years at Duke, where he oversaw research that was often funded by drug companies, that led critics to charge that Califf is too close to industry to be an objective FDA leader.

Some of his critics, among them Democratic Senator Elizabeth Warren, of Massachusetts, backed down and agreed to support him after Califf provided more details about his Duke years and made assurances of his independence from industry.

In remarks just before the vote, Senator Lamar Alexander of Tennessee, chairman of the Committee on Health, Education, Labor and Pensions, called Califf a respected leader, top cardiologist, and longtime medical school professor. He did not discuss the FDA’s track record on painkillers.


“We’re very fortunate to have a man of this distinction accept this nomination,” the Tennessee Republican senator said. “His nomination has been widely applauded across this country and received strong bipartisan support in my committee.”

He said the agency needs a leader who is prepared to safely approve new drugs, reduce unnecessary regulatory barriers, and keep pace with medical innovation.

``We hear stories about drugs and devices that are avaialble outside the US before they are available here,’’ Alexander said.

Senator Patty Murray of Washington, a Democrat and ranking member of the committee, also supported Califf. She cited an ``action plan’’ developed by the FDA to tackle the opioid epidemic in local communities.

At a press conference Monday, Markey and West Virginia Senator Joe Manchin, both Democrats, pleaded for the FDA to crack down on pharmaceutical companies, whom they say have hooked thousands of people on pain killers.


Many of those eventually become addicted to heroin. An estimated 30,000 people a year die from opioid abuse.

Both senators said that Califf’s experience in the industry makes him the wrong man to oversee such a policy change.

“Dr. Califf is a good man, an honorable man, “ said Manchin, “But I told Dr. Califf it would be culturally hard for him to change.”

Markey said they planned to continue their push to change the agency’s opioid policy, and that, even if Califf was confirmed, they would try to push Congress to attach strings to the FDA’s funding next year to require stronger measures against opioid abuse and related heroin use.

Markey blamed the FDA for perpetuating the opioid epidemic by approving the drugs too liberally without consulting outside experts.

“The Food and Drug Administration is supposed to be our nation’s pharmacist, but right now it is prescribing dangerous and addictive painkillers without limits, without supervision and without consequence,” he said. “This must stop.”

Markey is calling for the FDA to consult advisory committees of outside experts on all opioid approval decisions. He also wants the FDA to reverse its approval of prescription painkiller OxyContin — an opioid — for use in children, which was approved last year without consultation from an advisory committee.

The administration has defended Califf.

“The president and the administration have full confidence in the ability of our nominee,” White House press secretary Josh Earnest said during a January briefing. “The president would not have nominated him to the job if he didn’t think that he would be able to effectively look out for the interests of middle-class families in that role.”

Over the past decade, heroin use more than doubled among young adults 18-25, according to the Centers for Disease Control and Prevention.

In 2014, more than 1,300 people in Massachusetts died of overdosesof prescription opioids and heroin, Markey said.

Earlier this month, the FDA released a plan to combat the opioid abuse epidemic, including toughening warning labels and improving treatment. The plan will not require the FDA to consult with outside experts before approving all prescription opioids.

Sheila Kaplan of STAT contributed to this report. Sophia Bollag can be reached at Follow her on Twitter @SophiaBollag.