Inside Health Policy | Health Groups Sue FDA Over Deeming Rule Delays, But Attorney Questions Suit’s Viability

This week, the Biden Administration announced the first 10 Medicare Part D drugs selected for price negotiation and House Budget Committee Chair Jodey Arrington (R-TX) announced a Budget Committee Health Care Task Force and a Request for Information.

This week, PAHPA reauthorization legislation was marked up in both the House Energy and Commerce and Senate HELP Committees and HHS distributed $47.8 million in funding to combat substance use disorders.

This week, President Biden unveiled his FY 2024 Budget, and ASPR released a cybersecurity implementation guide for health care organizations.

This week, the Biden Administration released a final rule on surprise billing, President Biden issued an Executive Order on the implementation of the CHIPS Act of 2022, and HHS took action to strengthen access to reproductive health care. 

Alston & Bird has expanded its health care and life sciences regulatory and compliance capabilities with the addition of counsel Alexandra Marzelli, former associate chief counsel at the U.S. Food and Drug Administration (FDA). Based in the firm’s Washington, D.C. office, Marzelli joins Alston & Bird’s Health Care and FDA/Food, Drug & Device Groups, where she will advise clients on the FDA’s complex approval process and regulatory compliance for prescription and over-the-counter drugs, biologics, medical devices, food ingredients, and other products regulated by the agency.