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Mass. lawmakers push to remove opiate from market

WASHINGTON -- Lawmakers from Massachusetts are leading an effort to force a newly approved prescription painkiller off the market, saying the high-potency drug could make a national epidemic of opiate drug abuse even worse.

A bipartisan bill introduced last week by Representative Stephen F. Lynch, the Massachusetts Democrat, and Representative Hal Rogers, the Kentucky Republican, would require the Food and Drug Administration to withdraw approval of the drug Zohydro. The legislation would also bar the FDA from green-lighting similar medication if it does not have tamper-proof design features.

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“We cannot afford to allow yet another highly addictive opioid into the mainstream and potentially onto Main Street America,” Lynch said in a statement.

Zohydro is made up of hydrocodone, a synthetic opiate that is released over a 12-hour period. The painkiller, cleared by the FDA in October, is the first single-ingredient hydrocodone drug approved for U.S. patients. Because it does not cut with other compounds, that makes it even more potent than oxycodone, the widely prescribed painkiller that has been blamed for prescription drug addictions across the country.

The effort in Congress comes as the agency faces a torrent of criticism from consumer watchdog groups and addiction specialists who say Zohydro will aggravate already-rising overdose numbers. Hydrocodone and other prescription opiates contributed to more than 16,650 deaths in 2010, a fourfold jump from 1999, according to the Centers for Disease Control and Prevention.

On Friday, Vermont’s governor and the majority of the state’s city mayors sent a letter calling on the FDA to pull the drug from the market.

Zogenix, Inc., the manufacturer of Zohydro, told the Globe in a statement the company is confident in the FDA review process and its decision. Zogenix said it is developing other versions of the drug to deter abuse.

“Zogenix has always been, and will continue to be, committed to the chronic pain patient and ensuring they have appropriate access to safe and effective therapies to manage their pain,” the company said in a statement.

In clearing the drug, the FDA bucked the recommendation of its own advisory panel. The agency has said the benefits of the drug for treating chronic pain outweigh its risks.

“The FDA’s goal is to balance the important public health concerns around the misuse and abuse of extended-release opioids with the need for continued patient access to effective pain medications,” FDA spokeswoman Morgan Liscinsky said in a statement.

Attorneys general from dozens of states, including Martha Coakley of Massachusetts, wrote to the FDA in December calling for a review of the decision.

Members of Congress — including Lynch and Massachusetts Democratic Representatives Michael E. Capuano, William R. Keating, John F. Tierney and James P. McGovern — also asked the agency in a letter to reconsider the drug’s approval.

Keating, along with Joseph P. Kennedy III and Katherine Clark, both Massachusetts Democrats, have signed on as co-sponsors of Lynch’s legislation. Other Democratic lawmakers from New England — Representatives Rosa L. DeLauro of Connecticut, Michael Michaud of Maine and Carol Shea-Porter of New Hampshire — support the measure.

In the Senate, Senator Joe Manchin, the West Virginia Democrat, introduced similar legislation.

Kimberly Railey can be reached at kimberly.railey@globe.com.
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