Pubdate: Fri, 05 Feb 2016
Source: New York Times (NY)
Copyright: 2016 The New York Times Company
Contact: http://www.nytimes.com/ref/membercenter/help/lettertoeditor.html
Website: http://www.nytimes.com/
Details: http://www.mapinc.org/media/298
Author: Sabrina Tavernise

PRESSURED ON OPIOIDS, F.D.A. TAKES STEPS TO TOUGHEN STANCE

Under pressure from Congress to take action amid a worsening opioid 
epidemic, the Food and Drug Administration on Thursday announced 
several measures aimed at dealing with abuse.

Dr. Robert Califf, the acting commissioner and nominee to run the 
agency, announced the measures in a phone conference with reporters. 
He said the steps were an attempt by the agency to toughen its 
response to the crisis, in which tens of thousands of Americans were 
addicted to the prescription painkillers and were dying of overdoses. 
He said the actions were part of a broader government effort: Earlier 
this week, the Obama administration said it would ask Congress to 
spend an additional $1.1 billion next year on the problem, which 
would help increase badly needed treatment facilities.

"It has reached a point where we felt we had to step back and take a 
careful look at everything and see what we could do," Dr. Califf 
said. "We thought we could do more."

The decrees include convening an expert panel before approving some 
new opioids, strengthening requirements to study a drug after it has 
come to market, and increasing access to training on pain management 
for doctors and other prescribers.

Drug treatment experts welcomed the measures, but some said they were 
unlikely to change much.

"What I'm seeing here is the F.D.A. attempting to say something in 
response to congressional concerns, perhaps in response to the holdup 
of approval of the new F.D.A. commissioner, without actually having 
any vision for change," said Dr. Nathaniel Katz, an assistant 
professor of anesthesia at Tufts University School of Medicine in 
Boston, whose company, Analgesic Solutions, develops treatments for pain.

Last month, Senator Edward Markey, Democrat of Massachusetts, became 
the latest lawmaker to block Dr. Califf's nomination, over what he 
said was the agency's limp response to the drug crisis. He said the 
department had "willfully blinded itself to the warning signs."

Dr. Califf acknowledged that the broader concern from Congress had 
been noted at the agency.

"The level of concern is quite high from people in Congress," he 
said. "This is an extraordinary situation."

In a statement, Mr. Markey said the measures "fall short of what is 
needed," and said he would continue to block Dr. Califf's candidacy.

The F.D.A. has come under fire for continuing to approve opioids. 
Hillary Clinton publicly condemned the agency's decision in August to 
allow prescriptions of OxyContin, a powerful painkiller, for 
children. Its approval in 2013 of a drug called Zohydro brought 
public outcry over what critics saw as yet another opioid in a market 
flooded with them. "The F.D.A. has appeared to be somewhat nonchalant 
in their approach to the opioid epidemic," said Dr. Carl R. Sullivan 
III, the director of the addictions program at West Virginia University.

But Dr. Sullivan, who has seen the opioid epidemic up close - West 
Virginia is among the hardest-hit states - said he saw the measures 
as a sign that the agency might be trying to shift course.

Some are steps addiction treatment specialists have long been asking 
for, like increasing the drugs studies after they come to market.

"I am hopeful," he said.
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MAP posted-by: Jay Bergstrom