The U.S. Food & Drug Administration (“FDA”) is looking to elbow its way into the medical testing business by mandating stricter regulations that would slow the process of bringing lab-developed tests (“LDTs”) to market. LDTs are common medical diagnostic tests that have led to both diagnostic advances and setbacks that affect the everyday consumer. (FDA News Release, U.S. Food and Drug Administration). The FDA’s regulation was previously opened for a 60-day comment period and was met with vigorous discussion. Regardless, the FDA moved forward with the regulations on April 29, 2024, and has been met with legal push back and Congressional commentary that could threaten the future of the proposed rule. (Chair Rogers, U.S. House Energy and Commerce Committee).  This post examines the current structure of LDT regulations, their marketability, and how this regulation change will affect small startups and patient experiences.

The Department of Justice (“DOJ”) announced a new safe harbor policy for mergers and acquisitions, and companies are grappling with the potential benefits and pitfalls of utilizing the policy. The policy is a product of the DOJ’s focus on corporate criminal enforcement, as national security-related corporate crime has doubled from last year to this year. As highlighted by Deputy Attorney General Lisa Monaco, corporate crime intersects with “national security in everything from terrorist financing, sanctions evasion, and the circumvention of export control, to cyber-and crypto-crime.” (Lisa Monaco, U.S. Department of Justice). The DOJ has identified mergers and acquisitions as a source of access to corporate crime that threatens national security. Through this policy, the DOJ is hoping to create a “virtuous cycle” of acquiring companies identifying and reporting potential crimes committed by the  target companies during the due diligence stage, thereby assisting the DOJ in identifying and prosecuting individuals. Id. This cooperation spares the target company from prosecution as long as the acquiring company pays back any ill-gotten funds. Id. In exchange for their whistleblowing efforts, acquiring companies are protected from prosecution, provided they follow additional requirements. This post will examine the concerns and risks acquiring companies utilizing the safe harbor policy face.