Pubdate: Tue, 23 Feb 2016
Source: Boston Globe (MA)
Copyright: 2016 Globe Newspaper Company
Author: Sophia Bollag


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."

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 thisreport. 
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MAP posted-by: Jay Bergstrom