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Home » Topics » Regulatory » Legislation

Legislation
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Environmental Protection Agency - US EPA

US House committee sends signal to EPA on EtO regulation

Feb. 15, 2024
By Mark McCarty
The ongoing saga of the Environmental Protection Agency’s (EPA) pending rule on ethylene oxide (EtO) made its way to a Feb. 14 hearing in the U.S. House of Representatives, which included the testimony of Lishan Aklog of Pavmed Inc., who warned that a significant curtailment of EtO as a sterilant for medical devices could hamper patient access to medical devices.
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Health professional reviewing digital health data

US Senate evaluates site-specific use of AI in health care

Feb. 8, 2024
By Mark McCarty
Many health care facilities in the U.S. have deployed artificial intelligence (AI) algorithms that are tailored for the patient population seen in those clinical settings, a practice that avoids FDA regulation by removing the question of commercial distribution.
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U.S. flag, stethoscope

Budget scoring a concern for breakthrough device coverage legislation

Feb. 7, 2024
By Mark McCarty
The U.S. Medicare program for coverage of U.S. FDA-designated breakthrough devices has gone through some significant alterations over the past few years, but there is legislation on Capitol Hill that would codify this program at the Centers for Medicare & Medicaid Services. Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), told BioWorld that one of the sources of drag on this kind of legislation is how the Congressional Budget Office (CBO) scores the legislation, a problem that might not be resolved until CBO works through other legislation.
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Digital brain and silhouette

FDA’s device center meets MDUFA hiring goals in fiscal 2023

Jan. 25, 2024
By Mark McCarty
The U.S. FDA’s device center has at times struggled to make the volume of hires under the reigning Medical Device User Fee Agreement (MDUFA), but that wasn’t a problem in fiscal year 2023.
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U.S. Capitol building

New effort to reform patent eligibility in play in US Senate

Jan. 24, 2024
By Mark McCarty
The ongoing controversy over patent subject matter eligibility gained new momentum via a Jan. 23 U.S. Senate hearing, during which a bipartisan pair of senators once again pushed the argument that current jurisprudence for subject matter eligibility is hampering U.S. life science companies.
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Microscope with beakers and flasks

Advamed wary of government plan to privatize US helium depot

Jan. 23, 2024
By Mark McCarty
Legislation passed in the U.S. Congress in 2013 called upon the federal government to dispense with the Federal Helium Reserve by September 2021, a deadline that some stakeholders are grateful to see has passed without action.
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U.S. Capitol building

US FDA rolls out companion diagnostic pilot to overcome LDT problem

Jan. 2, 2024
By Mark McCarty
The U.S. FDA has commenced with a pilot program for companion diagnostics (CDx) for oncology therapies, which fulfills in part a 2014 agency guidance on the use of CDx. The FDA expects to enroll only nine reference drugs and the associated companion test, but the pilot program is part of the FDA’s controversial attempt to deal with lab-developed tests (LDTs), specifically those tests that are used to determine whether a patient is likely to respond to a particular oncology treatment.
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Respironics hit with $2.5M settlement for FCA allegations

Jan. 2, 2024
By Mark McCarty
The U.S. Office of Inspector General (OIG) reported that it and Philips Respironics have come to terms over allegations that the company violated the False Claims Act (FCA) by offering free CPAP masks to operators of sleep clinics
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2023 FDLI Enforcement Conference

FDA facing a ‘somewhat unimaginable’ volume of applications for LDTs

Dec. 8, 2023
By Mark McCarty
The U.S. FDA’s draft rule for lab-developed tests (LDTs) has proven to be every bit as controversial as expected, although the controversy is only marginally about the workload that would come with rulemaking.
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U.S. Capitol building, Washington D.C.

FDA’s Califf says delays in user fee legislation could trigger layoffs

July 12, 2022
By Mark McCarty
Legislation that would renew the U.S. FDA’s user fee programs is stuck in process on Capitol Hill, a predicament that seems to resist resolution to date. FDA commissioner Robert Califf said on a July 12 webinar that the FDA “is a decision-making machine” that is reliant on both user fees and congressional appropriations, and that a failure on the part of Congress to act on user fee legislation may force the agency to halt new hires and possibly lay off some FDA staff.
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