Long-Term Opioid Efficacy Act of 2018

Mr. Speaker, I rise in strong support of H.R. 5811, which amends the Federal Food, Drug, and Cosmetic Act with respect to post approval study requirements for certain controlled substances.

H.R. 5811 allows the FDA to require that pharmaceutical manufacturers study certain drugs after they are approved to assess any potential reduction in those drugs' effectiveness for the conditions of use prescribed, recommended, or suggested in labeling.

In recent years, many communities have been devastated by the number of overdoses that have been related to the escalating opioid epidemic.

According to U.S. Department of Health and Human Services, illegal substances, deadly synthetics such as fentanyl, and legally available pain relievers accounted for more than 42,000 deaths across the country in 2016.

Further, in the city of Houston, there were 364 drug-related overdose deaths alone that happened in 2016 according to the Treatment Center, a highly respected drug and alcohol addiction treatment service center.

This is a national emergency that deserves immediate action.

H.R. 5811 would expand an existing mandate that requires drug developers to conduct post-approval studies or clinical trials for certain drugs.

FDA will provide doctors and patients the information they need to use medicines wisely.

This will ensure that drugs, both brand-name and generic, work correctly and that their health benefits outweigh their known risks.

Under current law, in certain instances, the FDA can require studies or clinical trials after a drug has been approved.

H.R. 5811 would permit the FDA to use that authority if the reduction in a drug's effectiveness meant that its benefits no longer outweighed its costs.

I urge my colleagues to join me in voting to pass H.R. 5811.

Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 5811) to amend the Federal Food, Drug, and Cosmetic Act with respect to postapproval study requirements for certain controlled substances, and for other purposes, as amended.

Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days in which to revise and extend their remarks and insert extraneous materials into the Record on the bill.

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, I want to speak in favor of this bipartisan bill and thank Representative McNerney and Representative Griffith for working so hard to advance this important policy.

Currently, there are limited data on the long-term efficacy of opioids, their increased addictive tendencies over time, and their overall place in the treatment of pain. This legislation will enhance the Food and Drug Administration's authorities and enforcement tools to ensure timely post-marketing studies for chronically administered opioids.

Collecting and analyzing data is the best way to ensure that patients and physicians have access to evidence-based treatments. This bill will advance our understanding of the science underlying long-term use of opioids, and I encourage my colleagues to support its passage.

Mr. Speaker, I especially appreciate the work of the sponsors of this bill, including Representative Griffith, who would be here with us to speak in favor of this legislation but for traffic congestion on his way back from his district that has detained him from getting here as he had previously scheduled.

Mr. Speaker, I encourage my colleagues to support the bill, and I reserve the balance of my time.

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, I rise in support of H.R. 5811, the Long-Term Opioid Efficacy Act of 2018, authored by Representatives McNerney and Griffith.

Despite the prevalent use of opioids today in combating pain, the long-term

impacts of opioids and whether or not they are truly the most effective treatment is still fairly unknown.

FDA Commissioner Gottlieb testified before the Energy and Commerce Committee that many opioids have not been studied for chronic administration and further studying could help address certain questions. This includes the long-term efficacy of opioids and whether opioids may contribute to increased addictive tendencies over time.

This legislation would help us better understand the long-term impacts of opioids and whether opioids truly are the most effective treatment for chronic pain management by allowing the FDA to require manufacturers of controlled substances, such as opioids, to conduct post-market studies to assess the effectiveness of these products and whether or not they pose an increase in serious risk.

Under current law, the FDA has the authority to request postmarket studies relating to the safety considerations of a drug, but it does not have explicit authority to do so related to the efficacy of a drug. It is our hope that, by granting this authority to the FDA, we will better understand the long-term impacts of opioids that are chronically administered and encourage more responsible prescribing of opioids moving forward.

Mr. Speaker, I urge my colleagues to support this legislation, and I yield back the balance of my time.

Mr. Speaker, I yield back the balance of my time.