Pa. considers restricting access to potent new painkiller

Pennsylvania’s House will take up a plan to limit access to a newly available and controversial prescription painkiller.

The House Human Services Committee has approved proposed restrictions on Zohydro, an opioid medication approved by the federal Food and Drug Administration last fall.

Public health advocates say the drug is dangerously addictive, stronger than other painkillers on the market, and could contribute to an epidemic of drug abuse and fatal overdoses in Pennsylvania.

The plan sent to the full House would require doctors to do a medical evaluation and a risk assessment before writing a prescription for the drug. It would also subject patients to urine screenings and pill counts to guard against abuse of the medication.

Sponsor Rep. Gene DiGirolamo admits the proposed requirements make up a long list.

“It is – a lot of work for the doctors,” he said. But DiGirolamo, R-Bucks,  remains incredulous that Zohydro was ever approved over the objections of the doctors on the FDA’s expert advisory committee. They voted 11-2 against the drug’s federal approval in 2012.Pennsylvania wouldn’t be the first state to attempt to limit access to the prescription painkiller.

Vermont’s governor issued emergency restrictions on the drug last month, as reported by the Burlington Free Press. Meanwhile, a federal judge blocked a Massachusetts ban on the painkiller issued by Gov. Deval Patrick, as the Associated Press reported.A nearly unanimous vote Tuesday sent the proposed Pennsylvania restrictions to the full House, though several lawmakers had reservations about putting a greater burden on doctors.

“I’m very concerned with the issue here, I’m just wondering if there’s not another way … to do this, without sort of continuing to intervene between a practice and a patient,” said Pam DeLissio, D-Montgomery.

By way of response, DiGirolamo offered a blistering critique of FDA Commissioner Margaret Hamburg.

“She is completely out of touch with the reality of what we’re seeing here on the ground – people dying, people being incarcerated,” said DiGirolamo. “People are dying from this stuff. We don’t need another drug that’s 10 times more – it’s almost pure heroin when you get the maximum dose.”