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State Rep ‘Outraged’ at FDA, Drafts Bill to Restrict Zohydro

A painkiller that has five to ten times more opioid than any other drug on the market was approved by the Food and Drug Administration last year, and a Pennsylvania lawmaker isn’t happy.

Rep. Gene DiGirolamo (R-Bucks County) is sponsoring a bill that would regulate the use of Zohydro, a pure formulation of hydrocodone, in Pennsylvania. The drug was approved by the FDA, even though its medical board voted 11 to 2 against it.

“The FDA went over the heads of their own medical board and approved this,” DiGirolamo said.

DiGirolamo, who is “outraged the FDA allowed this to happen,” isn’t directly proposing a state ban on Zohydro because of a ruling in Massachusetts in April. After Massachusetts banned the drug, a federal judge struck it down, saying the state had no authority to overrule the FDA’s approval.

“[My bill will] not absolutely ban it, but put a lot of different rules and regulations in place here in Pennsylvania before a doctor can prescribe it,” DiGirolamo said. “And make it much harder for them to prescribe, until we can really look at what this FDA did.”

These regulations include a medical evaluation and risk assessment of the patient before a doctor prescribes Zohydro, a signed consent form, a set maximum daily use and scheduled follow-up visits and evaluations.

The bill comes in response to a growing opiate problem in Pennsylvania. In January, 22 deaths were linked to fentanyl-laced heroin in western Pennsylvania. In Allegheny County, fatal overdoses, including prescription and illegal drugs, increased from 100 in 1997 to 268 in 2012.

DiGirolamo, chair of the House Human Services Committee, said Zohydro is “fueling the heroin epidemic.”  The representative is calling for the resignation of FDA Commissioner Margaret Hamburg.

“Our kids are dying out there because of this prescription drug epidemic, and you’re putting something on the market that is almost pure heroin,” DiGorolamo said.

The Human Services Committee will consider the bill Tuesday.

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