Shaheen, Capito Lead Bipartisan IMPACT Act to Reform Opioid Use Disorder Medication Holding Period for Providers

November 23, 2021

(Washington, DC) – U.S. Senators Jeanne Shaheen (D-NH) and Shelley Moore Capito (R-WV) introduced bipartisan legislation that would increase the amount of time a physician can hold long-acting injectable (LAI) buprenorphine – a form of medication for opioid use disorders – from a specialty pharmacy. U.S. Representatives Madeleine Dean (PA-04), Victoria Spartz (IN-05), Mary Gay Scanlon (PA-05) and Brian Fitzpatrick (PA-01) led the companion legislation of the IMPACT Act in the House of Representatives.

The current 14-day window is a barrier to health care providers utilizing LAI buprenorphine due to the logistical hurdles associated with specialty pharmacy delivery. This legislation reforms the law that was envisioned in the SUPPORT Act by allowing health care providers to hold the drug in their facility for up to 60 days. It helps to facilitate continuity of care and treatment for Americans with opioid use disorders by reducing an unnecessary barrier to this innovative treatment method.

“The substance use disorder epidemic was a crisis in our communities before COVID-19 hit, but after two years of battling the pandemic, we’ve experienced one public health emergency exacerbate another with over 100,000 overdose deaths in a 12-month period. Now more than ever, we must ensure that no stone is left unturned in our response efforts to assist those in recovery, which is precisely what our bipartisan, bicameral legislation would help us achieve,” said Senator Shaheen. “Medication-assisted treatment is part of our multi-faceted strategy to combat the substance use disorder crisis, and our legislation makes a commonsense reform to improve access so providers can deliver the treatment those struggling with addiction urgently need.”

“The most recent overdose death data from the CDC is yet another sign that we need to redouble our efforts to fight the addiction crisis,” said Senator Capito. “Along with preventing substance abuse before it starts and stopping the flow of drugs into our communities, treatment is a critical component of this fight. The bipartisan bill Senator Shaheen and I are authoring would support those struggling with the disease of addiction by increasing access to Mediation Assisted Treatment, and better equip medical providers in helping them on their road to recovery.”

This bill is supported by the American Society of Addiction Medicine, American Psychiatric Association, American Medical Association, Advocates for Opioid Recovery, Aimed Alliance, Association of Nurses in AIDS Care, Center for U.S. Policy, FORCE, Kennedy Forum, Maryland Heroin Awareness, Mother’s Addiction Journey, No More OD’s Inc., Partnership to End Addiction, Prevention Action Alliance, Shatterproof, The Voices Project, Tyler’s Light and Young People in Recovery.

Bill text is available here.

Following reports that the manufacturer of buprenorphine, which is used to treat those suffering from opioid-related substance use disorders in medication-assisted treatment (MAT), was attempting to use the orphan drug approval process to secure an additional seven years of exclusivity and block potentially cheaper generic versions of the medication from appearing on the market, Shaheen sent a letter to the FDA calling on the agency to prevent the manufacturer from abusing the system. As a result of Shaheen’s actions, the FDA revoked buprenorphine’s orphan drug status.

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