FDA moves to tighten rules on painkiller

The Food and Drug Administration (FDA) announced it is shifting its policy on how patients can obtain certain painkillers.

Hydrocodone drugs, such as Vicodin, have long had less stringent prescribing regulations, but that could all change in early 2014, the regulator said Thursday.

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For 14 years, lawmakers in the House and Senate have been urging the FDA to reclassify the drug from a Schedule III to a Schedule II drug — putting it in line with other painkillers such as morphine, fentanyl and oxycodone that require a doctor’s written prescription.

“Due to the unique history of this issue and the tremendous amount of public interest, we are announcing the agency’s intent to recommend to [the Department of Health and Human Services] HHS that hydrocodone combination products should be reclassified to a different and more restrictive schedule,” the FDA said in a statement, adding that it would submit that official proposal by early December.

Rep. Vern Buchanan (R-Fla.) urged the Health Department to accept the agency’s recommendation.

“Too many of our loved ones are dying every day from prescription drug overdoses and are abusing hydrocodone painkillers for non-medical purposes,” he said in a statement. Sen. Charles Schumer (D-N.Y.), a staunch backer of the change in policy, tweeted his support.

“Rx drug abuse kills more than heroin & cocaine combined. I’m glad the FDA has recommended tighter controls,” Schumer wrote.

Sen. Joe Manchin (D-W.Va.) sent out a message Thursday, saying, “The agency has just saved hundreds of thousands of lives.”

Buchanan and then-Rep. Edward Markey (D-Mass.), Manchin and Sen. Mark Kirk (R-Ill.) reintroduced legislation earlier this year aimed at forcing regulators to reschedule the drug, but it never reached the House or Senate floor.

Those lawmakers and Sens. Jay Rockefeller (D-W.Va.) and Kirsten Gillibrand (D-N.Y.) also wrote to the administration at least three times this year to push for the change, which an FDA expert advisory panel voted 19-10 to approve.

The agency in March told Congress, in a letter obtained by The Hill, not to expect quick action on the issue, and referred to the amount of regulatory red tape involved in changing how the drugs are classified.

In order to finalize the rescheduling, the HHS must accept the FDA’s recommendation and the Drug Enforcement Administration (DEA) would then adopt and enforce it. The DEA has long been a supporter of the change, which would also require stricter storage and inventory recordkeeping requirements.

Members point to a petition that was originally filed with the regulator in 1999 asking for the rescheduling of hydrocodone, and say the number of chronic abusers of the painkiller had increased to more than 24 million since the request was filed.

Recently released lobbying disclosure records show that more than 15 different groups and companies lobbied on the hydrocodone schedule change within the last three months, including the drug company AbbVie (which manufactures Vicodin), the Generic Pharmaceutical Association, Walgreens Co. and the American Association of Nurse Practitioners.

Drug wholesalers and distributers were some of the interests opposed to the regulations, citing the costs of increased security. Changing the drugs from a Schedule III to a Schedule II would require hydrocodone combination products to be moved from a secure cage in their warehouse to a concrete vault, according to DEA rules.

In 2010, 2 million people reported using prescription painkillers non-medically for the first time within the previous year, according to a report by the Centers for Disease Control and Prevention (CDC).

There has been a 300 percent increase in painkiller prescriptions in the United States, the CDC reported. In 2008, nearly 15,000 people died from a painkiller overdose, according to the most recent data available.