The National Association of Attorneys General has sent a letter to the Food and Drug Administration asking the agency to require generic drug makers to make tamper-resistant versions of opioid painkillers.
The letter, signed by attorney generals from 48 states and territories, says there is “great concern” among law enforcement and public health officials that new generic painkillers that are not tamper-resistant will be abused.
“The abuse of prescription drugs is a significant danger and has reached epidemic levels in many of our states,” the attorney generals wrote to FDA Commissioner Margaret Hamburg.
“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. 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.”
In recent years, several popular painkillers, including OxyContin and Opana, have been reformulated to make the drugs harder for addicts to crush and snort. However, patents on some of the medications are expiring, allowing generic drug makers to produce generic versions that are not tamper resistant.
In January, Impax Laboratories (NASDAQ: IPXL) began selling a generic version of Opana (oxymorphone) that is not tamper-resistant. A federal judge dismissed a lawsuit by Endo Pharmaceuticals that would have prevented generic Opana from coming on the market. Endo’s extended release version of Opana is tamper resistant and is still under patent protection.
The FDA has not tried to block generics and has denied several citizen petitions from Endo and other pharmaceutical companies to withhold approval of generics that are not tamper-resistant. Instead the agency issued draft guidelines to drug makers encouraging them to conduct further studies of medications they developed to prevent abuse.
“We applaud the FDA for expeditiously proposing guidelines establishing clear standards for manufacturers who develop and market tamper – and abuse-resistant opioid products while considering incentives for undertaking the research and development necessary to bring such products to market. Most importantly, we encourage the FDA to assure that generic versions of such products are designed with similar features,” said the letter from the attorney generals.
A bill under consideration in Congress would prevent the FDA from approving generic drugs that lack the tamper resistance of other products on the market. The Stop Tampering of Prescription Pills Act (STOPP) is sponsored by Rep. William Keating (D-Massachusetts).