Last week the US Food and Drug Administration (FDA) finalised its risk evaluation and mitigation strategy (REMS) for ER/LA opioids after three years working on the project. The impact on drug approvals was largely overlooked in news coverage and the opioid industry is staying quiet too.
“Purdue doesn’t discuss our pipeline and we can’t comment on the potential actions of the FDA in regard to the approval of drugs,” Libby Holman, associate director of public affairs at Purdue Pharma, told in-PharmaTechnologist.com.
Drugs sold by Purdue account for one-third of innovator ER/LA opioids covered by the REMS. Other firms with affected products include Pfizer, Actavis, Janssen and Endo Pharmaceuticals.
Endo also declined to comment on the impact of the REMS but voiced its support for the project. “We support this REMS as part of national efforts to address the epidemic of prescription drug abuse in the US,” Kevin Wiggins, corporate communications at Endo, told this publication.
The REMS makes manufacturers of ER/LA opioids fund continuing education activities aimed at raising physician and patient awareness of risks posed by the drugs. Firms looking to enter the ER/LA space must consider this burden but the plan was never to discourage new entrants.
Speaking at a media briefing in 2009, John Jenkins, director of the Office of New Drugs at the Center for Drug Evaluation and Research at the FDA, said: “We don’t think that the need for a class REMS stands in the way of approval of additional members of the class.”
Taking this stance keeps the door open for development of formulations that can cut the risks and abuse-potential of ER/LA opioids, such as products that eliminate possible dose dumping.
Since the FDA began developing the REMS in 2009 some important elements have changed, namely the dropping of plans to make education on ER/LA REMS mandatory for prescribers.
The FDA encountered resistance to this plan and prescriber education is voluntary in the final REMS. This could change if the FDA achieves its goal of seeing Congress make education a part of the US Drug Enforcement Agency (DEA) registration process for opioid prescribers.
Until then prescribers can choose whether to take the education programmes. The provision of manufacturer-funded educational activities is, however, mandatory for companies selling ER/LA opioids. Manufacturers have until March 1 2013 to put educational programmes in place.
At a media briefing to discuss the REMS, Margaret Hamburg, commissioner of the FDA, said the goal is to have 60 per cent of current prescribers receive training within four years of the project starting.