Painkillers may face tougher FDA regulations
Thursday , June 07, 2012 - 4:46 PM
WASHINGTON - Vicodin and other hydrocodone- combination painkillers may face tighter federal oversight following repeated reports of misuse and addiction that have been flagged by the Drug Enforcement Administration.
Advisers to the Food and Drug Administration, which regulates pharmaceutical sales, will meet in October to discuss the risks and benefits of hydrocodone preparations used as pain relievers or cough suppressants, the agency said in a notice posted Thursday on its website. The DEA has been taking a closer look at rules for hydrocodone combinations since 1999.
Prescription pain relievers are the second-most abused drug in the United States after marijuana, with hydrocodone-related emergency room visits more than doubling from 2004 to 2010, according to the Substance Abuse and Mental Health Services Administration. Consumers have easier access to hydrocodone through combination drugs, such as the acetaminophen-mixed Vicodin, which have fewer regulations than pure hydrocodone.
The DEA is seeking to change the drug classification in a way that would require more interaction with doctors in order for people to obtain those combination products.
"It has to do with penalties for trafficking," Barbara Carreno, a spokeswoman for the enforcement agency, said in a telephone interview. "You have to go back to the doctor when you run out of medicine. It's more oversight by the doctor."
A change in such classifications may benefit companies including Zogenix Inc., which is developing a pure form of hydrocodone that would have to compete with less controlled substances such as Abbott Laboratories' Vicodin and the generic equivalents.
Zogenix submitted an application to the FDA for its product, Zohydro, in May. The San Diego-based company says Zohydro doesn't contain acetaminophen, which avoids the potential for liver injury.
"We already understood that Zohydro will be regulated as a DEA Schedule II product versus the currently marketed hydrocodone combination products which are all Schedule III," Catherine O'Connor, a Zogenix spokeswoman said in an email. "We are supportive of measures to help with the responsible prescribing of hydrocodone and other opioid products."
Hydrocodone is an opioid considered by the DEA to be a Schedule II controlled substance, the second-highest level on a five-stage scale that takes into account the potential for addiction. Hydrocodone combinations are one class lower and as a result have fewer restrictions on sales.
Senate legislation passed May 24 that allows the FDA to collect $6.4 billion in review fees includes a provision to restrict access to hydrocodone products. A version passed by the House doesn't contain hydrocodone language. The two chambers are working out the differences in the bills they must pass before the current user fee programs expire Sept. 30.