Painkiller abuse has become so prevalent that FDA is working with pharma to create a strategy for handling misuse of all drugs across the entire opioid category.
FDA isn’t slouching on opioid abuse. The agency met recently with an industry work group consisting of members from a number of drug firms to discuss progress on a risk evaluation and mitigation strategy (REMS) to end opioid abuse. This includes drugs that are commonly associated with accidental overdose and addiction, such as morphine and oxycodone.
The group, last Friday, proposed a phased-in approach for a REMS for this class of products. According to John Jenkins, director of the Office of New Drugs the working group agreed to conduct a public advisory meeting about this topic in the spring.
The thinking is that once FDA has had time to digest the information and create the path forward, the agency will seek expert opinions from advisors and offer another opportunity for the public to give its comments.
One area discussed in detail was the idea of having physicians who prescribe Class 2 narcotics trained before they can obtain mandatory certification from the Drug Enforcement Agency (DEA). Physicians seeking registration would be required to certify that they received training to prescribe the medication. DEA does not have that authority at this time, and legislation would be required to move that proposal forward. Voluntary training programs for physicians-almost as a continuing education situation-was discussed as an alternative.
Some stakeholders said they were concerned that there might be some apprehension by doctors to prescribe opioids if the training and certification requirements are too burdensome.
“There are some serious ongoing concerns with the use of these products that we need to address,” Jenkins said. “We can hear all the concerns and the issues, but the IWG’s job is to find a solution that meets the twin goals of ensuring the safe use of these drugs while ensuring access for patients. We are required to put the REMS in place to ensure that the benefits of these drugs continue to outweigh their risks.”