AGs concerned that drug companies may soon introduce opioid painkillers without new tamper-resistant protections that curb abuse
(DES MOINES, Iowa) Attorney General Tom Miller today called on the U.S. Food and Drug Administration to require opioid painkiller manufacturers to produce tamper-resistant generic versions of their prescription drugs.
In a letter to FDA Commissioner Margaret Hamburg, Miller and 46 state attorneys general expressed concern that drug companies may soon introduce generic versions of extended release painkillers in their original formulations, without tamper-resistant formulas. Users could crush, snort, chew or inject these generic drugs, enabling potential opioid misuse and abuse.
Opioids are a class of drugs that are similar to morphine and heroin. Medications that fall within this class include hydrocodone (e.g., Vicodin), oxycodone (e.g., OxyContin, Percocet), morphine (e.g., Kadian, Avinza), codeine, and related drugs.
“The Centers for Disease Control reports that more people die from overdosing on opioids than from heroin, cocaine and all other illegal drugs combined,” said Miller. “The FDA can and should do more to stop this senseless prescription drug epidemic. We’re urging the FDA to make it much harder for people to abuse painkillers in a way that won’t affect patients who really need them for pain.”
In 2010 drug manufacturer Purdue Pharma introduced a tamper-resistant form of its best-selling painkiller OxyContin (oxycodone). In November 2012, a study in the American Pain Society’s The Journal of Pain found that tamper-resistant extended-release oxycodone reduced the drug’s abuse by 41 percent. Non-oral abuse dropped by 66 percent, and oral abuse dropped by 17 percent, according to the study.
“One of that study’s co-authors compares an original oxycodone pill’s consistency to aspirin, which means it’s easy for someone to crush and abuse it,” Miller said. “The newer tamper-resistant pill has a consistency similar to a piece of Skittles candy. When you smash it, it flattens instead of crushing into a powder. That, along with the drug’s reformulated makeup makes it very difficult to abuse it,” added Miller. “The FDA should make these types of drugs safer by requiring tamper resistance for all extended release opioid painkillers.”
Currently, the FDA requires that drug manufacturers cannot carry labeling claims of tamper resistance on reformulated drugs until they have been on the market long enough to be sufficiently studied. Contending that the FDA’s current tamper resistance standards are vague, drug companies are preparing to distribute and market non-tamper resistant generic extended release opioid painkillers.
“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,” the attorneys general wrote in their letter to the FDA.
In January the FDA proposed 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. The FDA has sought public comment on the draft guidance and plans to hold a public meeting to receive and discuss feedback.
“I applaud the FDA for proposing guidelines, but we need to do even more to fight the scourge of prescription drug abuse,” said Miller. "The FDA needs to unequivocally require drug companies to ensure that generic opioids are tamper resistant."
Miller also voiced support for the Stop Tampering of Prescription Pills Act of 2013, or STOPP Act (H.R. 486). The STOPP Act would establish new requirements for the approval of brand-name and generic drugs that are otherwise available in a tamper-resistant formulation. Rep. William Keating (D-MA) introduced the bill on February 4, and it has been referred to the Committee on Energy and Commerce.
State attorneys general in Alabama, North Carolina, Florida and Kentucky led the effort in submitting the letter to the FDA on behalf of Miller and other state attorneys general. In addition to the 46 state attorneys general who signed onto the letter, attorneys general in Guam and Puerto Rico also signed on.
FDA information on opiod medications: