Opioid Review Modernization Act of 2016

Floor Speech

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Mr. PALLONE. Mr. Speaker, I wish to voice my support for H.R. 4976, which would complement the efforts taken by the Food and Drug Administration to combat the opioid abuse crisis.

The opioid epidemic has hit nearly all communities across the country--young and old, rich and poor, urban and rural. The Energy and Commerce Committee has held a number of hearings on this issue, inviting a wide range of stakeholders to come and share with us their suggestions on how Congress can help to address this crisis. What has been made clear is that there is not one solution. It will take the collaboration and expertise of a variety of agencies, and it must not only appropriately account for the need for access to opioids for those with acute and chronic pain, but it must also discourage misuse and diversion.

As the public health agency responsible for reviewing pain medications for safety and efficacy, the Food and Drug Administration should play a critical role in making clear how prescription opioids can be safely used, in encouraging the development of technologies to prevent abuse, and identifying what education would assist prescribers who treat patients with opioids.

In February, FDA outlined an action plan that included a number of steps focused on the agency's regulatory approach to opioids.

These actions included: reassessing the risk-benefit approval framework for opioid use; convening an expert advisory committee before approving any new drug application for an opioid that does not have abuse-deterrent properties; consulting with the Pediatric Advisory Committee regarding recommendations for pediatric opioid labeling before any new labeling is approved; updating the Risk Evaluation and Mitigation Strategy or REMS program for extended-release and long- acting opioids regarding prescriber training; developing changes to immediate-release opioid labeling to include additional warnings and safety information; reviewing options to make naloxone more accessible, such as availability over-the-counter; and strengthening post-market requirements, among other steps.

I was pleased by the agency's announcement as I believe it was an important step forward in improving regulatory oversight of opioids, and would help to take another step towards addressing the opioid crisis holistically.

H.R. 4976, the Opioid Review Modernization Act, was introduced by Representatives Sean Patrick Maloney and Leonard Lance to build on the actions announced by the FDA. The legislation would require the agency to work closely with expert advisory committees before making critical product approval and labeling decisions, make recommendations regarding education programs for prescribers of extended-release and long-acting opioids, and would encourage the development and approval of generic opioids with abuse-deterrent properties.

These actions will be critical to improving the way we regulate opioids to ensure that these products are used safely and appropriately and I urge my colleagues to support this legislation.

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