State attorneys general have joined forces to urge the FDA to mandate more difficult-to-abuse versions of prescription pain medications—specifically, generic opioid analgesics.
In a letter dated March 11 to the FDA, the group of 48 state attorneys general asked the agency to adopt drug development standards outlining how manufacturers of generic prescription painkillers should develop abuse- and tamper-resistant versions of the analgesics. The FDA has issued a draft directive defining the requirements for developing tamper-resistant opioids that does not make it mandatory. The directive is expected to be finalized sometime in March.
The attorneys general noted that brand-named versions of opioids such as OxyContin (Purdue; oxycodone) and Opana ER (Endo; oxymorphone) have taken steps to make it more difficult to abuse their drugs, such as making it harder to crush pills, which is often done by abusers to make the drug easier to inject or snort. Yet, the FDA is faced with the contentious issue of generic opioids. Purdue and Endo have filed Citizen Petitions separately with the FDA over the past year in an effort to force generic opioid formulations to prove they are tamper-resistant in order to stay on the market.
The concern is that prescription drug abusers will simply avoid the new tamper-resistant formulations as long as standard agents in the class are available; in many cases, that means generic versions of opioids.
“In our states, 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,” the attorneys general wrote in their letter to the FDA. “There is great concern in our law enforcement community that many non–tamper-resistant products are available for abuse when only a few products have been formulated with tamper-resistant features.”
“By making prescription opioids tamper-resistant, we can further safeguard people from deadly prescription drug abuse,” stated Florida’s attorney general Pam Bondi. Ms. Bondi sent a similar letter to the FDA in October 2012, asking that all manufacturers of prescription opioids develop tamper-resistant formulations. Alabama attorney general Luther Strange, Kentucky attorney general Jack Conway, North Carolina attorney general Roy Cooper, and Ms. Bondi led the current effort.
The Centers for Disease Control and Prevention cites fatal drug overdose as the leading cause of unintentional injury death in the United States. Motor vehicle deaths are second.
In February 2012, the FDA issued a draft directive outlining requirements for tamper-proof opioid development; among them were conducting randomized controlled, double-blind trials showing “the ease with which the potentially abuse-deterrent properties of a formulation can be defeated or compromised.”
The letter was signed by attorneys general from Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Washington, West Virginia, Wisconsin and Wyoming. The letter also was signed by attorneys general from Guam and Puerto Rico.