Today, the United States Senate passed an end-of-year legislative package that included two ASHP advocacy priorities. The package included the Mainstreaming Addiction Treatment (MAT) Act, which removes a federal barrier on pharmacists prescribing buprenorphine, known as the X-waiver.
To prescribe medications for opioid use disorder, pharmacists must be legally authorized to dispense controlled substances under state law and complete at least eight hours of training for treating and managing patients with opioid or other substance use disorders.
The legislative package also includes several provisions addressing pharmaceutical supply issues. It directs the Department of Health and Human Services (HHS) to identify incentives to increase domestic production of generic pharmaceutical products and to award contracts to increase the domestic production capacity of antibiotics, including their active pharmaceutical ingredient or key starting materials. The bill also includes an ASHP policy recommendation to increase the transparency of the Strategic National Stockpile by requiring HHS to issue guidance describing how the Strategic National Stockpile deploys its contents.
Finally, the bill includes a provision that provides the Food and Drug Administration (FDA) with greater oversight over its accelerated approvals program. Specifically, the legislation requires drug sponsors to begin post-approval studies before a drug hits the market and streamlines the process for FDA to pull drugs from the market when sponsors fail to conduct studies or when studies fail to demonstrate a drug's clinical benefit.
The bill is expected to be passed in the House and signed into law.