NACDS urges FDA to move carefully in risk management rules for opioids

ROCKVILLE, Md. Note to the Food and Drug Administration from the chain pharmacy industry: when it comes to beefing up oversight and regulation of some high-risk medications, slow and steady is the best approach.

As the FDA mulls new, broad-based requirements on the dispensing and monitoring of all medications in the opioid class of painkillers, the National Association of Chain Drug Stores is weighing in with a cautious, if qualified, endorsement. That support came today from Kevin N. Nicholson, NACDS VP and pharmacy adviser for government affairs and public policy, who addressed a joint meeting of the FDA’s Anesthetic and Life Support Drugs Advisory and Drug Safety and Risk Management Advisory committees.

The meeting was set up to study the agency’s proposal to require all painkillers in the opioid class of medicines to follow the FDA’s Risk Evaluation and Mitigation Strategies guidelines. The agency first unveiled new REMS requirements for the makers of some higher-risk specialty medications in 2007. Thus far, the biggest target for those new REMS requirements has been the opioid class of painkillers, given their narcotic properties and the risks they carry for abuse and addiction.

Nicholson told the joint panel that NACDS "supports the measured approach to REMS that the FDA appears to be embracing, as evidenced by the FDA’s proposal for the classwide opioid REMS." However, he added, "The FDA must carefully navigate between mitigating the risks of these medications while also not negatively impacting patient care."

"We are pleased that the proposed REMS for long acting and extended release opioids follows the advice of stakeholders that emphasizes caution and deliberation over speed," said the NACDS executive. "Take time to develop the REMS and allow for stakeholder input to prevent negative consequences."