Enforcement Relief: What New Regulatory Reforms Could Mean for Hospices
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
The top legal issues in 2024 for the life sciences field reflect the complex and changing legal landscape that the industry is navigating, encompassing drug pricing, regulatory challenges, and broader societal and governance...more
On February 6, 2024, the Federal Trade Commission (“FTC”) commented in support of what would be a historic expansion of government march-in rights under the Bayh-Dole Act in response to the release of the National Institute...more
Under the University and Small Business Patent Procedures Act of 1980 (35 U.S.C. §§ 200-212), commonly referred to as the Bayh-Dole Act, the federal government can exercise “march-in” authority in certain circumstances to...more
This legislative session, Florida has joined Arkansas and Oklahoma among the most regulatory-minded states with respect to pharmacy benefit plans and programs as well as pharmacy benefit managers (PBMs). Florida's...more
Inflation Reduction Act Implementation: On Dec. 1, 2022, the Centers for Medicare & Medicaid Services (CMS) distributed an invitation addressed to “All Drug Manufacturers” announcing that CMS “will host monthly one-hour calls...more
On July 17, 2017, the U.S. Court of Appeals for the District of Columbia Circuit ruled in favor of the Department of Health and Human Services (HHS), finding that the American Hospital Association’s (AHA) legal challenge of...more
Throughout his presidential campaign, President Trump championed the need to allow the government to negotiate drug prices on behalf of the Medicare program. However, that third rail for pharmaceutical companies was not...more