Latest From Laura Helbling
US House of Representatives if moving forward with a bill to respond to advocacy from ALS patients for more attention from FDA. The bill focuses on planning and scientific support, not new pathways.
Participants in a US FDA meeting on opioid REMS did not treat a move to mandatory education as a foregone conclusion. Instead, they delved frequently into alternate approaches to enhance the education itself.
US FDA is once again asking whether its opioid Risk Evaluation & Mitigation Strategy program for opioids should make continuing education requirements mandatory for prescribers. This time there may be no choice but to move forward with the plan.
FDA and NIH are looking to spark research on approaches to reduce use of benzodiazepines and to help mitigate issues with withdrawal associated with the widely prescribed therapies.
Three of the US FDA’s former leaders believe the agency is coming through COVID with its reputation intact. They still support making the agency independent of the broader Health & Human Services Department, but the urgency may be gone.
New incentives will most likely not be the immediate focus, but working group to explore ideas on enhancing understanding of drug effects in elderly populations will likely be formed by US FDA.