The FDA’s policies on analgesic labeling appear to be limiting the potential for novel non-opioid pain medicines to qualify for separate payments in Medicare after CMS said the indication must be for post-operative use.

A Senate hearing on the medical product supply chain suggests there is bipartisan support for ‘buy American’ policies for federal Rx purchases, and for country-of-origin labeling to help those policies expand to the private sector.

Alternative therapies designed to avoid, eliminate, or reduce the use of opioids may be eligible for Breakthrough Therapy Designation or Priority Review, the US FDA draft guidance says.

The White House is directing the Health and Human Services Department to replenish stockpiles of active pharmaceutical ingredients for “especially critical” medicines.

Legislation prohibiting work with certain Chinese biopharma firms will be reintroduced soon, Democratic Sen. Gary Peters said. And it will not be the only bill tied to international biotech competition and security concerns that will be considered.

Sanofi’s Xenpozyme and Sentynyl’s Nulibry are the first two case studies the FDA is using to continue educating rare disease sponsors on best practices.