Newsletters

10.16.24

CBO Publishes Report Detailing Alternative Approaches to Reduce Prescription Drug Pricing

On October 4, the Congressional Budget Office (CBO) published a report analyzing the potential fiscal implications of seven policy approaches aimed at reducing the net prices of retail prescription drugs.


09.18.24

House Passes BIOSECURE Act

As part of the House’s “China Week”—focusing on legislation to curb threats from Beijing—the House passed the BIOSECURE Act (H.R. 8333) on September 9 with strong bipartisan support (in a 306–81 vote).


05.06.24

FDA Finalizes Rule to Phase Out Enforcement Discretion of Laboratory-Developed Tests

On April 29, the U.S. Food and Drug Administration (FDA) released a final rule that will gradually phase out FDA’s long-standing policy of enforcement discretion for laboratory-developed tests (LDTs), subjecting them to the same enforcement approach as other in vitro diagnostic (IVD) products.


03.25.24

Congress Revisits Longstanding Debate Over FDA Regulation of Lab-Developed Tests

On March 21, 2024, the Health Subcommittee of the House Energy & Commerce Committee held a hearing titled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.”


02.27.24

The FDA and the Future of AI Oversight

In January 2024, the U.S. Government Accountability Office (GAO) issued a report highlighting current obstacles to the U.S. Food and Drug Administration’s (FDA) timely and effective regulation of artificial intelligence (AI) and machine learning (ML) in medical devices and other emerging ...


03.14.23

Biden Administration Seeks $500M to Implement and Enforce No Surprises Act and Mental Health Parity

President Biden’s proposed 2024 budget includes substantial additional amounts for continued funding of the implementation and enforcement of the No Surprises Act and the transparency laws passed along with the NSA.