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Home » Topics » Regulatory

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FDA website and logo
FDLI Annual Meeting

Recent FDA activity hints at impending commercial speech enforcement

May 17, 2024
By Mark McCarty
The U.S. FDA has several methods for signaling its enforcement intentions regarding medical devices and drugs, but there are times when warning letters are the vectors for communicating the agency’s current thinking.
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U.S. flag and money

US FTC meets reality on budget request amid overreach concerns

May 16, 2024
By Mari Serebrov
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.
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CMS wants more info for Medicaid price stacking rule

May 16, 2024
By Mari Serebrov
The U.S. Centers for Medicare and Medicaid Services (CMS) is rethinking its proposed “stacking rule” for determining best price in the Medicaid program.
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Report leads to suspension of Ecohealth, NIH rebuke

May 16, 2024
By Mari Serebrov
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.
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Helsinn gives up on Truseltiq accelerated approval in US

May 16, 2024
By Mari Serebrov
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.
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Joshua Smiley, president and chief operating officer, Zai Lab

Zai Lab exec buys stock as Augtyro, Vyvgart SC advances in China

May 16, 2024
By Marian (YoonJee) Chu
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.
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U.S. Capitol building

US Biosecure bill zooms through committee to House floor

May 16, 2024
By Mari Serebrov
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.
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Pills, syringes, financial charts

Economics cited as a driver of worsening drug, device shortages

May 16, 2024
By Mark McCarty
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.
Read More
U.S. flag and money

US FTC meets reality on budget request amid overreach concerns

May 15, 2024
By Mari Serebrov
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.
Read More
Cyber eye illustration
FDLI Annual Meeting

US legislation for AI described as ‘long-term process’

May 15, 2024
By Mark McCarty
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.”
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