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A bipartisan Senate bill would limit opioid prescriptions for short-term pain to seven days.
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.
“Our bipartisan bill would target one of the root causes of the opioid addiction crisis, which is the over-prescription of these powerful and addictive drugs for acute pain,” Gillibrand said in an April 13 statement. “Too many lives have been destroyed, too many families have been torn apart, and too many communities all over New York are suffering because of this tragic epidemic. I am proud to join with Senator McCain in this urgent fight against the over-prescription of opioids, and I look forward to seeing it pass through the Senate as quickly as possible.”
McCain said the bill “is an important step forward in preventing people from getting hooked on these deadly drugs.”
Marc Brumer, a spokesman for Gillibrand, told Bloomberg BNA in an April 14 email the senators are still determining the “best next steps for the bill’s success.”
But one possible vehicle to move the bill forward is legislation to reauthorize the Food and Drug Administration’s user fee programs.
Bloomberg Intelligence analyst Brian Rye told Bloomberg BNA, “This is one of many measures affecting the pharmaceutical industry that could possibly be added to the user-fee reauthorization bill this summer.”
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.
The opioid epidemic could become a major focus at the FDA.
Scott Gottlieb, President Donald Trump’s pick to head the FDA, said April 5 the opioid epidemic should be the agency’s highest priority. Gottlieb spoke at a Senate Health, Education, Labor and Pensions Committee hearing. Gottlieb still has to be confirmed as the FDA commissioner.
The Alliance for Patient Access (AfPA) is concerned that the bill could have some unintended consequences. The AfPA is a national network of physicians dedicated to ensuring patient access to approved therapies and appropriate clinical care.
Brian Kennedy, executive director of the AfPA, told Bloomberg BNA in an April 14 email, “while we support their recommendation to not apply prescribing limitations to those dealing with chronic pain and cancer, we are concerned about unintended consequences patients with legitimate medical needs may face because of arbitrary restrictions placed on prescribing.”
“We encourage lawmakers to focus on access to integrated pain care that provides nonopioid options for treating chronic and acute pain,” Kennedy said. “A balanced approach gives patients more options to treat their pain while reducing the amount of opioids prescribed and the risk for addiction to occur.”
Kennedy said, “Better access to abuse deterrent formulations can also offer relief to patients while reducing the risk of misuse, abuse and diversion. We also encourage increased research into new, innovative nonopioid-based pain medications.”
“We urge Senator McCain and Senator Gillibrand to focus on a balanced pain management approach and subsequent public health policies that can lead to more relief for pain patients while helping to curb the abuse of opioids,” Kennedy said.
The American Medical Association and the American Academy of Family Physicians told Bloomberg BNA they haven’t taken a position on the bill.
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