Law360 | The Defining Pandemic Moments for Health and Life Sci Attys

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.

Cathy Burgess, partner in Alston & Bird’s Health Care Group and leader of the firm’s FDA Compliance & Enforcement Team, has been recognized by The National Law Journal in its third annual list of professionals identified as agents of change in health care and life sciences law.

Alston & Bird has formed a working group to advise clients on the business and legal implications of the COVID-19 coronavirus.

This week, the House passed an appropriations bill to fund HHS and other agencies for the remainder of fiscal year (FY) 2024, with the Senate expected to vote shortly, and CMS introduced the ACO Primary Care Flex Model.

This week, CMS finalized a rule on the Medicaid Disproportionate Share Hospital (DSH) program, clarifying hospital-specific DSH payment limits, and the House launched a bipartisan Artificial Intelligence (AI) Task Force to study AI-specific legislative proposals.