Articles and Blogs

The Gilbert Family Foundation, Henry Ford Health and Shirley Ryan AbilityLab announced plans for a $439M inpatient rehab hospital and research facility in Detroit. Plans for the project include a 125,000-sf inpatient tower with 72 beds. According to a recent Bloomberg article, private equity is no longer a reliable last resort as a buyer of…Read More

On May 2, 2023, in a move intended to accelerate the adoption of digital health technologies, the U.S. Food and Drug Administration (“FDA”) released draft guidance regarding the conduct of decentralized clinical trials (“DCTs”) for drugs, biological products and devices. This draft guidance expands on previous FDA recommendations released in the midst of the COVID-19…Read More

A group of California tech billionaires spent $800M to acquire nearly 50,000 acres of land between Sacramento and San Francisco to develop what they are calling a “modern metropolis”. The project, if approved, would be one of the largest development projects in the works nationally. While detailed plans have not been released, the project will…Read More

On June 27, 2023, the Food and Drug Administration (“FDA”) issued its Final Guidance for the presentation of “Quantitative Efficacy and Risk Information” in Direct-to-Consumer (“DTC”) promotional labeling and advertisements for prescription drug and biological products, prescription animal drugs and DTC promotional labeling for over-the-counter animal drugs. The Final Guidance provides recommendations on how to…Read More

After no enforcement actions for the first six months of 2023, enforcement from the Food and Drug Administration’s (“FDA”) Office of Prescription Drug Promotion (“OPDP”) is heating up with two new letters issued in the month of August. The first was a Warning Letter issued on August 4, 2023, to a pharmaceutical manufacturer for making…Read More

On September 1, 2023, the Centers for Medicare & Medicaid Services (“CMS”) released a proposed rule (“Proposed Rule”) that calls for minimum staffing standards in long-term care facilities (“nursing homes”). If finalized, the changes in the Proposed Rule would be used to survey nursing homes for compliance and enforced as part of CMS’s existing survey, certification…Read More

In the past two years, many health systems have been selling their long-term care, home health, nursing home, hospice and lab businesses, largely due to rising costs and regulatory pressures. This trend reflects a shift from ownership to partnership models as hospital systems focus on cost reduction and operational simplicity. Despite some financial struggles last…Read More

On August 16, 2023, a three-judge panel of the Fifth Circuit Court of Appeals issued an opinion in the ongoing litigation regarding the U.S. Food & Drug Administration (“FDA”) approval and regulation of mifepristone (brand name Mifeprex), a drug used in medically induced abortions. The panel vacated in part and affirmed in part a decision…Read More