A bipartisan Senate bill that would limit opioid prescriptions for short-term pain to seven days could be added to legislation to reauthorize the FDA’s user fees.
Sens. John McCain (R-Ariz.) and Kirsten Gillibrand (D-N.Y.) April 7 introduced the Opioid Addiction Prevention Act of 2017 (S. 892). The legislation would require medical professionals to certify, as part of their registration with the Drug Enforcement Administration, that they won’t prescribe an opioid as an initial treatment for acute pain in an amount that exceeds a seven-day supply, and won’t provide a refill. This limit doesn’t apply to treating chronic pain, pain being treated as part of cancer care, hospice or other end-of-life care, or pain treated as part of palliative care.
The bill is intended to keep patients from becoming addicted to opioids when they are prescribed these drugs for short-term pain, such as for a broken bone or wisdom tooth extraction. The bill was referred to the Senate Judiciary Committee for consideration.
The senators are still determining the “best next steps for the bill’s success,” Marc Brumer, a spokesman for Gillibrand, told me in an email.
But one possible vehicle to move the bill forward is legislation to reauthorize the Food and Drug Administration’s user fee programs.
“This is one of many measures affecting the pharmaceutical industry that could possibly be added to the user-fee reauthorization bill this summer,” Bloomberg Intelligence analyst Brian Rye told me.
All of the FDA’s user fee programs expire Sept. 30, and Congress is preparing to consider legislation to reauthorize the programs for fiscal years 2018 through 2022. The drug industry pays user fees to the FDA, and in return, the FDA commits to meeting certain performance goals. The agency has separate user fee programs for prescription drugs, generic drugs, biosimilars and medical devices.
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