October 14, 2013

Scheme in Washington could hurt W.Va. communities, Manchin calls emergency Senate hearing | Bluefield Daily Telegraph

WASHINGTON — U.S. Sen. Joe Manchin called Wednesday for an emergency Senate hearing into reports of a “pay to play” scheme in Washington that could be hurting West Virginia communities by making it easier for doctors to write prescriptions for certain painkillers.

Citing a report by Peter Whoriskey of The Washington Post, Manchin said that private pharmaceutical companies paid as much as $25,000 per meeting recently to participate in a Food and Drug Administration advisory panel discussions on federal regulations for prescription painkillers.

Two academic researchers set up the meetings, in order to provide advice to the FDA on how to weigh evidence from clinical trials.

A leading FDA official later called the group “an essential, collaborative effort.”

According to Manchin, the “pay to play scheme” could explain why FDA officials have disregarded recommendations by its own advisory panel to make it harder for patients to be prescribed certain hydrocodone pills.

“I am gravely concerned by the allegations of ‘pay to play’ between the FDA and pain medicine companies and am calling for a full investigation to see how deep this goes,” said Manchin. “If these allegations are true, they explain why it has taken the FDA almost a year to reach a decision to reschedule hydrocodone even after their own expert advisory panel recommended it.”

The FDA “schedules,” or classifies, drugs based in part on how addictive they can be and how “easy” it is to fall into abusing them. The schedule system is designed to protect patients’ interests. The system also regulates how doctors write scripts for drugs.

Eight months ago, an internal FDA panel of 29 scientists and researchers had urged FDA regulators in a 19-to-10 vote to re-classify hydrocodone/acetaminophen combination drugs like Lortab and Vicodin as “Schedule II” because they have a higher potential for addiction and abuse.

The Schedule II classification would limit doctors to writing only one 30-day prescription for the pills, under typical circumstances. (A 90day supply could be written on three, separate scripts.) To date, the FDA still classifies hydrocodone “combo” drugs as Schedule III, meaning that doctors may legally write prescriptions with up to five refills — a key draw for addicts and those who sell the drugs on the black market for huge profits.

“I’m asking for a full Senate investigation,” said Manchin Wednesday. “I want to find out how someone adopted the policy of ‘pay to play.’ “I’ve never heard of such a thing,” Manchin told reporters. “That might explain why we have never been able to get the hydrocodone rescheduled.

“This is ridiculous — having a government agency ... paid to say what’s on the market,” he said. “It doesn’t make sense to me.”

Manchin stopped short of accusing FDA officials of criminal wrongdoing.

He added, “But I sure as heck want to find out.”

Manchin said it at least appears that the $9 billion painkiller industry in the United States may have influenced public policy in a way that has increased drug addiction in West Virginia.

Manchin added that when the National Institutes of Health challenged the FDA on the panel, FDA officials continued with the arrangement, anyway.

“It looks like they were buying access to direct policy and not to the benefit of the consumer,” Manchin said. “I’m going to take it all the way to the Department of Justice and anywhere else.”

The Center for Disease Control has reported an increase in overdose deaths each year since 1999, with 60 percent of the overdose deaths involving prescription drugs.

Of the prescription drug deaths, oxycodone, hydrocodone, methadone and others represented 75 percent of the deaths.

Manchin, who has pushed for a reclassification of hydrocodone combo drugs for several years, had testified last year before the Drug Safety and Risk Management Advisory Committee that hydrocodone combination drugs should be rescheduled, due to the high risk of addiction.

“All manufacturers of the drugs have opposed it,” he reported.

West Virginia has the highest rate of deaths due to drug overdoses in the nation, according to a national report released Monday.

“It is a shame that some of these companies were able to influence the FDA’s decision with a $25,000 contribution, while West Virginian families are destroyed by the addiction these pills cause,” Manchin stated.

Manchin acknowledged reports from constituents that some pill abusers take advantage of public assistance to get painkiller prescriptions from doctors and often sell those same pills in the community.

“For a Schedule III right now, if you get the right doctor, they can prescribe you six months (supply) in a day,” said Manchin. “If the law allows them to do it and maybe some would do it; they’re not breaking the law.

“If we get this rescheduled from III to II, they will be breaking the law.”