Citing the need to protect the public interest, the U.S. Department of Health and Human Services ordered an immediate government-wide funding suspension May 15 of Ecohealth Alliance Inc. while formal debarment proceedings are pending against the New York-based nongovernmental organization.
Following a cumbersome process, the U.S. FDA is withdrawing its accelerated approval for Truseltiq (infigratinib) as a second-line treatment for patients with unresectable locally advanced or metastatic cholangiocarcinoma harboring an FGFR2 fusion or rearrangement as detected by an FDA-approved test.
Zai Lab Ltd., of Shanghai and Cambridge, Mass., has been on a regulatory roll in China, gaining approval of Bristol Myers Squibb Co.’s Augtyro (repotrectinib) for lung cancer on May 12 and NMPA acceptance of subcutaneous Vyvgart‘s (efgartigimod alfa SC) supplemental BLA with priority review on May 14.
The Biosecure Act passed its first milestone in the U.S. House May 15 when the Oversight Committee voted 40-1 to favorably report the bill to the full House for a vote. Under the act, H.R. 8333, federal agencies would be prohibited from procuring biotechnology equipment or services from a “biotechnology company of concern” and from contracting, either directly or through a subcontract, with anyone that would use such equipment or services to perform the contract.
The U.S. FDA is not the only regulatory agency attempting to deal with impending and existing device and drug shortages, although some of the drivers of these shortages are not within these agencies’ purview. The FDA’s Jacqueline Corrigan-Curay told an audience here in Washington that the poor payment rates offered by payers for generic drugs are a significant contributor, adding that there are instances in which the per-dose rate paid for one of these generics is less than the typical charge for a cup of coffee.
The FTC’s request for a nearly 25% increase in funding for fiscal 2025 was splashed with cold water May 15 in a U.S. House Appropriations subcommittee hearing. That’s “a dramatic increase in funding for an agency whose work continues to raise concerns among many members of Congress and the public,” Rep. David Joyce (R-Ohio), chair of the Subcommittee on Financial Services and General Government, said as he opened the hearing.
Artificial intelligence recently roiled the regulatory world, but the U.S. Congress has yet to dive into the task of legislating on the concept. Barrett Tenbarge, general counsel for Sen. Bill Cassidy (R-La.) told an audience here in the nation’s capital that while the Senate is considering several legislative proposals, the desire to avoid legislation that will create as many problems as it solves suggest that legislative development “is a long-term process.”
The U.S. FDA’s final rule for regulation of lab-developed tests promises to remain controversial for the foreseeable future, but FDA commissioner Robert Califf said that many of these tests have been shown to be less than adequately reliable. Califf said that one of the effects of the final rule is that it will force clinical labs to “wake up and develop better tests,” if only because compliance and enforcement regimes will soon be applied to clinical labs.
The FDA’s Jeff Shuren appeared on a May 14 webinar to discuss operations at the Center for Devices and Radiological Health (CDRH), but he had some choice words for what he suggested is a widespread do-more-with-less mentality. Shuren said that expectations of CDRH’s capacity are in defiance of what he suggested is a modest volume of revenues the center receives each year, a predicament he said demonstrates that “a lot of people are running around stupid” about the realities at the FDA’s device center.
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