North America: Food, Drugs, Healthcare, Life Sciences

Today’s drug development programs routinely span continents: distributed research teams, multinational clinical trial networks, and complex webs of cross-border licensing, contract manufacturing...

Welcome to FDA in Flux – A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies.

Partner Jason Schultz explores the evolving role of in-house counsel in healthcare organizations, identifying five critical capabilities that legal professionals must develop to remain effective strategic partners. The article examines how modern healthcare lawyers can enhance their value by mastering skills beyond traditional legal expertise, including project management, emotional intelligence, and business acumen.

On May 18, the Supreme Court denied all six petitions for certiorari filed by drug manufacturers challenging the IRA’s Medicare Drug Price Negotiation Program, bringing much of the first wave of constitutional challenges to a close.

Developments since then, including renewed U.S. attention to most‑favored‑nation (“MFN”) drug pricing have heightened the legal and policy concerns associated with that notice. In our view, those concerns merit renewed scrutiny.

Today’s drug development programs routinely span continents: distributed research teams, multinational clinical trial networks, and complex webs of cross-border licensing, contract manufacturing...

On May 18, the Supreme Court denied all six petitions for certiorari filed by drug manufacturers challenging the IRA’s Medicare Drug Price Negotiation Program, bringing much of the first wave of constitutional challenges to a close.

Developments since then, including renewed U.S. attention to most‑favored‑nation (“MFN”) drug pricing have heightened the legal and policy concerns associated with that notice. In our view, those concerns merit renewed scrutiny.

CMS has issued nationwide moratoria on new Medicare enrollments for hospices and home health agencies, effective May 13, 2026, halting all new applications and branch expansions for at least six months.