Yesterday, the U.S. House of Representatives unanimously passed Congressman Jerry McNerney's (CA-09) bipartisan bill, H.R. 5811, the Long-Term Opioid Efficacy Act of 2018. Congressman Morgan Griffith (VA-09) was the lead Republican co-sponsor. H.R. 5811 grants the Food and Drug Administration (FDA) the authority to require that opioid manufacturers conduct post-market studies to examine the long-term efficacy of these drugs.
"Our country is in the midst of a national crisis," said Congressman McNerney. "Thousands in California have lost their lives as the result of an opioid overdose, yet we have little knowledge about the long-term effects of these medications, which are often prescribed for long-term usage. To combat this epidemic, we must give the FDA the critical tools it needs to understand an opioid drug's efficacy over time."
In March, the House Energy and Commerce Committee held a hearing with FDA Commissioner Scott Gottlieb where he explained why this authority would be a useful tool. During the hearing, Commissioner Gottlieb noted that many opioid drugs have not been studied for chronic administration, but are chronically administered. He went on to state that certain important questions could be answered by properly studying the chronic administration of these drugs and examining their long-term efficacy.
"I'm pleased this bill passed the House. This legislation will help ensure that the public is informed about the long-term effects of these powerful drugs," said Congressman McNerney.