Congress passed an end-of-year bill Dec. 23 that includes withdrawing a federal barrier to pharmacists prescribing an opioid overdose treatment and numerous strategies to manage persistent drug supply problems.
Four things to know from the proposed legislation:
1. One provision would remove the FDA's "X waiver" from buprenorphine, meaning that pharmacists who are authorized to dispense controlled substances and have at least eight hours of training for treating and managing patients with substance use disorders could prescribe the opioid dependence therapy.
2. It directs HHS to identify incentives that would achieve increased domestic production of generic medicines and antibiotics.
3. The bill aims to "modernize" the FDA's accelerated approval program, which includes requiring post-drug-approval studies before the treatment enters the market and simplifying the process of pulling a drug if drugmakers don't conduct studies or if the drug fails to show a clinical benefit. Recent delays in the fast-track drug approval program have cost the U.S. about $18 billion.
4. To combat shortages of medical products during an emergency, another provision would require HHS to issue guidance on how the Strategic National Stockpile distributes its supplies.