House Committee Leaders Pressure FDA on Opioid Black Boxes

Bipartisan leaders of the House Energy & Commerce Committee are asking the FDA why extended-release opioids require black box warnings and immediate-release versions of the painkillers do not.

A July 7 letter asks the FDA to provide studies it relied on in 2013 when deciding to exempt IR opioids from the warnings. It also raises a series of questions regarding studies and FDA statements on opioid abuse, pointing to the agency’s Guide to Safe Use of Pain Medicine, which states opioid compounds taken exactly as prescribed manage pain and rarely cause addiction.

In addition, the lawmakers — committee chairman Rep. Fred Upton (R-Mich.) and ranking member Frank Pallone (D-N.J.) and Oversight and Investigations Subcommittee chairman Tim Murphy (R-Pa.) and ranking member Diana DeGette (D-Colo.) — want to know how the FDA evaluates the effectiveness of risk evaluation and mitigation strategies for opioid drugs and whether there is evidence that REMS are effective. The letter cites a recent review by the Agency for Healthcare Research and Quality, which found no evidence the strategies were effective in controlling abuse in patients being treated for chronic pain.

The request follows a letter sent by 22 Democratic committee members to FDA Acting Commissioner Stephen Ostroff last month pointing out that evidence linking opioids to serious health risks does not distinguish IR from ER formulations.

The lawmakers want the FDA to respond by July 21. Read the letter at www.fdanews.com/07-13-15-opioidletter.pdf. — John Bechtel