Congress is once again tackling prescription painkiller abuse, zeroing in on how to prod the federal government to approve more drugs with features that deter abuse.
But such technology isn’t a silver bullet for this growing problem, according to doctors.
Painkiller overdoses kill 44 people a day in America, according to the Centers for Disease Control and Prevention. Overdose deaths started to take off in the nineties but dropped in 2012 and essentially leveled off.
With painkiller overdoses still a problem, lawmakers believe abuse-deterrent technology can be a potential problem solver. However, there are very few painkillers available that have such features, with one being the popular painkiller Oxycontin.
The most common abuse-deterrent technology prevents a pill from being snorted, usually by having it turn into a gel after it is crushed. The technology also prevents an abuser from chewing the pill to get a high more quickly.
The FDA finalized a draft regulatory guidance from 2013 on how drug makers can adopt abuse-deterrent technology. If it hadn’t done so by June the agency would have lost $20 million in funding from Congress, a threat that the agency apparently took seriously.
Earlier this week Sen. Joe Manchin, D-W.Va., introduced new legislation to revamp how the FDA approves drugs. Manchin was furious with the agency in late 2013 when it approved a painkiller called Zohydro without abuse-deterrent features.
The bill forces the FDA to justify why it would ignore recommendations from its advisors in approving a new painkiller. Agency advisors recommended Zohydro be rejected because of its abuse potential, but the FDA approved it anyway.
The technology isn’t a complete solution to the problem, physicians and experts say. For one thing, the features don’t prevent someone from abusing the drug orally.
The painkillers that are on the market are also more expensive than traditional painkillers, which can be $50 cheaper, Dave Stack, CEO of Pacira Pharmaceuticals, recently told the Examiner. Stack’s company makes non-opioid products for controlling pain after surgery.
He recently spoke during the Rx Summit, an event held by House Appropriations Committee Chairman Hal Rogers, R-Ky., a staunch advocate for action on this issue.
The FDA has guidance on how brand-name opioids can adopt this technology but there isn’t guidance for generics that occupy a majority of the painkiller market. The agency has said that guidance will be forthcoming.
Doctors are trying to better decide how to deal with pain after surgery. The first time a patient gets painkillers oftentimes is after a surgery, said Dr. Greg Mancini, general surgeon at the University of Tennessee Knoxville Hospital.
“We continue to evaluate best ways to minimize that,” Mancini said referring to opioid prescribing. He added that the hospital has looked at new medications that don’t have opioids.
Researchers are also looking into new drugs that lack the same abuse risk as regular painkillers, the FDA has said.
“There is sophisticated pain treatment out there for surgeries but it is not being utilized,” said Laura Clark, a professor and anesthesiologist at the University of Louisville Hospital.
Part of the issue is that it is much more expensive than current therapies, Clark said.
Hospitals need to understand the entire “continuum of care” for a patient and what happens after they leave, Mancini said.
