Lawmakers appeal to HHS chief over FDA approval of new pain pill

 

Lawmakers are turning to Health and Human Services Secretary Kathleen Sebelius to overturn the Food and Drug Administration's approval of a controversial prescription drug that is scheduled to hit the market later this month.

Sen. Joe Manchin (D-W.Va.) is the most recent lawmaker to criticize the Food and Drug Administration (FDA) for approving Zohydro, which critics say is a highly addictive and easily-abused prescription drug. 

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"Given the potentially imminent release of Zohydro later this month, it is imperative that you act as soon as possible to keep this dangerous drug off the market," Manchin wrote Monday in a letter to Sebelius, who overseas the FDA.

Machin is the second lawmaker to appeal to Sebelius to overturn the FDA's ruling from last October, after letters to the agency did nothing to unsettle its resolve. Sen. Charles Schumer (D-N.Y.) sent a similar letter last week.

Their requests to Sebelius come after a handful of lawmakers from both sides of the aisle and health activists first appealed to FDA Commissioner Margaret Hamburg to overturn her agency's decision.

"This is not the first letter you’ve received on this topic, and the FDA has been urged many times to overturn their approval," Manchin wrote. "Senators and congressmen from both parties have written several times demanding an explanation for the FDA’s head-scratching approval and requesting your intervention." 

Zohydro is the first FDA-approved drug that uses pure hydrocodone to treat chronic pain.

Other combination drugs mix hydrocodone with weaker, non-addictive painkillers such as aspirin to balance out the effects. But Zohydro contains up to 10 times as much hydrocodone as other combination drugs such as Vicodin, experts say.

The FDA approved Zohydro last October, contrary to the recommendation of one of its own advisory panels a year earlier, which warned against it because of the high levels of hydrocodone contained in the drug.

Critics are concerned the FDA's decision could increase prescription drug overdose rates and lead to abuse of the painkiller. Manchin pointed out that 16,000 Americans die each year from prescription drug abuse of opioid painkillers.

Hydrocodone is one of the most commonly abused medicines in the United States, according to the Drug Enforcement Administration. 

Manchin said the FDA "failed" in its duty to protect the public.

"Simply put, the FDA’s approval of Zohydro ER, in its current form, must be stopped before this dangerous drug is sold to the public," he said.