Don’t expect quick action on painkillers, FDA tells lawmakers

“The FDA shares your concerns regarding prescription drug abuse,” wrote Michelle Mital, the acting associate commissioner of legislation at the FDA. “We are strongly committed to finding ways to reduce and misuse of those medications.”

The agency said it is “analyzing and reviewing the data” from the advisory panel, but noted that the Drug Enforcement Administration (DEA) is ultimately responsible for reclassifying drugs, and required to follow a long rule-making process before doing so.

In order to reclassify the drugs — which would include the brand-name painkiller Vicodin — the DEA needs to publish information in the Federal Register and receive public comment, the FDA said in the letter.

To reschedule a drug, the FDA must also conduct research into the addictiveness of a medication. Its recommendations to the Department of Health and Human Services puts in motion a rulemaking process from the DEA. The FDA alone cannot change the schedule status of a drug.

{mosads}Lawmakers can also force the DEA to change the scheduling of the painkillers with legislation.

A House staffer, who signaled dissatisfaction with the FDA’s response, told The Hill that there is an impending bill to address the issue.

Changing hydrocodone from Schedule III to Schedule II would require that a patient present a hand-written prescription for the painkiller, rather than placing a call to the pharmacy.

Congress originally petitioned the FDA to make recommendations on hydrocodone rescheduling in 1999.

“It has been 14 years since the initial petition requesting that the FDA and [the Drug Enforcement Agency] evaluate the proper scheduling of hydrocodone combination drugs,” Buchanan, Markey and five senators wrote to the FDA last month. “In those 14 years, there has been a staggering number of hydrocodone related deaths and a drastic increase in non-medical users of these products.”

There were roughly 22,000 drug overdose deaths in 2010 and prescription drugs accounted for 60 percent of that total. Opioid painkillers – which include the brands OxyContin, Norco and Percocet – were involved in “3 of every 4 pharmaceutical overdose deaths,” according to the Centers for Disease Control and Prevention.


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