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Manchin calls for investigation in 'ridiculous' FDA, pharmaceutical situation

CHARLESTON, W.Va. -- U.S. Sen. Joe Manchin, D-W.Va., wants a "full fledged" investigation into allegations a Food and Drug Administration panel charged with crafting policies regulating prescription painkillers accepted thousands of dollars from pharmaceutical companies.

Manchin hopes the charge could lead to a reclassification for hydrocodone, a power prescription painkiller that's rampantly abused in West Virginia. 

"To me, it looks like they were buying access to change policy or direct policy not to the benefit of the consumer," Manchin said Wednesday morning during a conference call.

The FDA panel accepted as much as $25,000 from large pharmaceutical companies so the companies could attend and chime in at closed-door meetings, according to The Washington Post. The Post broke the story earlier this week after obtaining emails through a Freedom of Information Act.

The panel examined regulations and testing of prescription painkillers, helping shape the FDA's policy for the medication.

This week a national report indicated West Virginia has the highest fatal overdose rate in the nation. Most of those overdoses are attributed to prescription pills.

Hydrocodone is an active ingredient in power painkillers like Lortab and Vicodin. Another recently released report from the Center for Investigative Reporting shows the veterans hospitals in Beckley and Huntington have some of the highest prescription rates in the country. Between 2001 and 2012 both prescribed far more medication with hydrocodone than the three other prescription painkillers examined for the study.

Manchin said he's repeatedly pushed for the FDA to reclassify hydrocodone from a Schedule III drug to a Schedule II drug. Schedule II drugs have stricter limits for the amount that can be prescribed at one time, and require more input from a doctor.

"We wanted to make sure people are getting the medications they need and the amount they need, but by God the way they're (going about it) is wrong," Manchin said.

"It won't cure our drug problem, but it sure does give us a better handle."

Manchin said.

The Drug Enforcement Agency wants the reclassification and an FDA panel voted earlier in the year to reclassify hyrdocodone, but the FDA has yet to grant final approval for the shift.

"(I'm) totally, absolutely frustrated, trying to figure out a way for the FDA to try and reschedule hydrocodone," Manchin said.

He believes an investigation could help precipitate a change, but he also wants to see if the FDA or the pharmaceutical companies involved did anything illegal.

He sent a letter to FDA Commissioner Margaret Hamburg asking her to provide information about the panel's meetings, companies who paid to attend, panel recommendations and more.

"These press reports raise troubling questions about the FDA's delay in issuing a recommendation regarding this petition," Manchin wrote in the letter.

"I truly hope that the FDA is not allowing their relationship with the pharmaceutical industry to influence their duty to protect the American public."

Manchin said he expected Hamburg, members of the panel, officials from the companies and others to be subpoenaed for the hearing. The Washington Post story and Manchin's letter do not specifically name any pharmaceutical companies.

The partial shutdown of the federal government should not affect the hearing or investigation, Manchin said.

The senator bemoaned the shutdown, calling it "craziness" that needs to end. He said there needs to be a negotiation as to how to fund the government, and scolded Republicans for not accepting a previous deal from Democrats on the debt ceiling.

Manchin did not say if he would support a Democrat-backed measure to raise the country's borrowing limit without attaching any other amendments. He said he doesn't like the idea of attaching social policies to such a bill.

"But sooner or later we're going to have to be serious about fixing the debt of the nation," Manchin said.

Experts expect the county will reach the debt ceiling Oct. 17. Contact writer Dave Boucher at 304-348-4843 or david.boucher@dailymail.com. Follow him at www.twitter.com/Dave_Boucher1.


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