U.S. law allows whistleblowers to file suit for violations the False Claims Act, but the legality of these qui tam relators under the Appointments Clause is under intense scrutiny thanks to a case heard in Florida district court.

Three former officials with Magellan Diagnostics Inc., have entered guilty pleas in connection with faulty tests for lead poisoning that were widely used across the U.S. between 2013 and 2017. While former CEO Amy Winslow and two others will not be sentenced until later this year, all three face possible prison terms of three years or more and fines of as much as $250,000, highlighting the hazards of a lack of scruples with regard to compliance with U.S. FDA regulations.

The latest continuing resolution (CR) for the U.S. budget funds government operations through the end of the fiscal year, which in modern times may come across as an achievement. However, Medicare telehealth also won in the CR, which extends some temporary measures for telehealth as Congress continues to mull over the question of a permanent expansion of Medicare telehealth benefits.

Cardiothoracic surgeon and television personality Mehmet Oz, President Donald Trump’s nominee for administrator of the Centers for Medicare & Medicaid Services (CMS), faced the U.S. Senate’s finance committee on March 14, suggesting the implementation of artificial intelligence (AI) technologies and the reduction of drug prices would be among his top priorities, if confirmed.

The European Association of Medical Device Notified Bodies, also known as Team NB, has proposed the issuance of a conditional CE certificate for medical devices and in vitro diagnostics, a concept said to have existed in the legacy regulations as well. The question for industry is whether this mechanism can be used to aid in the backlog of devices under the Medical Device Regulation (MDR), a problem that is still front and center in the EU eight years after passage of the index legislation.

As expected, the U.S. Senate Health, Education, Labor and Pensions Committee voted March 13 to send the nominations of Jay Bhattacharya as NIH director and Martin Makary as FDA commissioner to the Senate floor for confirmation. Bhattacharya received a narrow 12-11 party-line vote, but Makary picked up some Democratic support to secure a 14-9 vote.

Shortly before the Senate Health, Education, Labor and Pensions Committee was to hold the first ever confirmation hearing for a U.S. CDC director March 13, it issued a statement saying the hearing was canceled due to the White House withdrawing its nomination of Dave Weldon, a physician and former congressman from Florida.

The U.S. FDA’s January 2025 draft guidance for test validation in public health emergencies drew only six responses, but pointed responses they were, indeed. As an example, the Association for Molecular Pathology (AMP) said the draft’s recommendation for the use of 30 positive and 30 negative (30/30) samples for validation of lab-developed tests is likely to hamper test availability in an emergent situation, a time when samples are likely to be difficult to obtain.

Looking to shave $65 million from its annual expenditures while streamlining the first stage of its two-level grant review process, the U.S. NIH is proposing to centralize the peer review of all applications for grants, cooperative agreements and R&D contracts within its Center for Scientific Review.

The U.S. FDA’s latest draft guidance on pulse oximeters drew comment from the International Standards Organization and the International Electrotechnical Commission, which are making the case that in addition to differences in pigmentation, the pulsatility of the tissue in contact with the device is also a factor in device performance.