WEST VIRGINIA ATTORNEY GENERAL ASKS FDA TO MAKE GENERIC PAIN PILLS HARDER TO ABUSE
CHARLESTON – West Virginia Attorney General Patrick Morrisey today said his office has joined with 47 other Attorneys General in a letter asking the U.S. Food and Drug Administration to ensure that generic manufacturers of opioid prescription drugs use tamper-resistant and abuse-resistant formulations.
The letter, which was sent to FDA Commissioner Dr. Margaret Hamburg, says prescription drug abuse is a significant danger and has reached epidemic levels in many states. The letter states the development of tamper-resistant opioid-based prescription pain relievers help to deter abuse and can be a part of a comprehensive approach when combined with prevention, interdiction, prosecution and substance-abuse treatment. Significantly, the Attorneys General from 46 states and two U.S. territories say they are concerned that nonmedical users are shifting away from the new tamper-resistant formulations to non-tamper-resistant formulations of other opioids as well as to illegal drugs.
“Like many other states and territories, West Virginia suffers from an epidemic of prescription drug abuse. The most recently available information from the Centers for Disease Control shows the Mountain State had one of the highest rates of drug overdose deaths in the nation in 2008 with more than 25 deaths per 100,000 people.(1) That is a very sad and scary statistic that is made all the worse when you think of the families and lives forever changed by this plague,” Attorney General Morrisey said.
“We joined in with other states and territories in the hope that if pharmaceutical manufacturers can make all prescription opioid-based pain relievers tamper-resistant and abuse-resistant, it will help to address one part of the prescription drug abuse problem.”
Attorneys General in Alabama, Florida, Kentucky and North Carolina are the lead authors of the letter. It applauds the FDA for proposing guidelines to establish clear standards for manufacturers who develop and market tamper-resistant and abuse-resistant opioid products while considering incentives for undertaking the research and development necessary to bring such products to market. The letter also encourages the FDA to assure that generic versions of the prescriptions are designed using formulations that deter abuse and misuse.
“At a time when opioid abuse is a serious problem for both the State of West Virginia and the nation, I hope the FDA will take seriously the potential impact of generic opioid-based pain relievers that do not incorporate tamper-resistant features,” Attorney General Morrisey said. “The last thing anyone wants is for old problems to reoccur simply because individuals shift to the generic brands that don’t utilize protective features.”
To read the letter from the 48 Attorneys General, click here
1. Centers for Disease Control and Prevention, National Center for Injury Prevention and Control, Division of Unintentional Injury Prevention. http://www.cdc.gov/homeandrecreationalsafety/rxbrief/