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1 month ago | 
jdsupra.com | David Dorsey |Emily Felder |Zachary S. Pfister
The Food and Drug Administration (FDA) is not likely to continue to review and approve human drugs or medical devices if the federal government shuts down in MarchThe federal government is currently funded through March 14, 2025, and it remains a possibility that Congress will not complete a continuing resolution or omnibus appropriations bill by that date to fund the government for the remainder of the 2025 fiscal year (FY).
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Dec 18, 2024 | 
jdsupra.com | Zachary S. Pfister
President-elect Trump’s nominee for commissioner of Food and Drugs, Martin A. Makary, MD, MPH, argued in 2016 that Congress should reform the Orphan Drug Act (ODA) because drug companies “are gaming the system to use the law for mainstream drugs.”[i] This alert summarizes his position, discusses some areas of contention about how the ODA works, and explores how these ideas could affect drug development if he is confirmed to lead the FDA.
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Sep 20, 2024 | 
mondaq.com | Sarah Johnson Auchterlonie |Leah Dempsey |Zachary S. Pfister |John Menges
On Sept. 17, the Consumer Financial Protection Bureau (CFPB)
published guidance for federal and state consumer
protection enforcement officials to use to prevent banks and credit
unions from charging overdraft fees in certain situations. The
guidance states that a financial institution cannot legally charge
overdraft fees for ATM and one-time debit card transactions if the
financial institution does not have proof of the consumers'
affirmative consent.
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Sep 19, 2024 | 
mondaq.com | Samantha Carl-Yoder |Zachary S. Pfister |Brandt Anderson |Maxwell Huntley
Last week, the House held its long-awaited "China
Week" to vote on a series of legislation targeting various
aspects of the U.S.-China relationship. The bills targeted national
security, economic relations, technology, the pharmaceutical
industry, and other key sectors. China Week was originally expected
to occur in June as a lead up to the annual National Defense
Authorization Act (NDAA) review, but it was postponed.
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May 30, 2024 | 
jdsupra.com | Leah Dempsey |Joel L. Herberman |Zachary S. Pfister
After much anticipation, the House passed House Financial Services Chairman Patrick McHenry (R-NC) and House Agriculture Chairman GT Thompson’s (R-PA) crypto regulatory legislation, the Financial Innovation and Technology for the 21st Century Act (FIT 21) (H.R. 4763).
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Feb 5, 2024 | 
jdsupra.com | Leah Dempsey |John Menges |Zachary S. Pfister
As abusive robocalls remain unpopular both politically and, in general, universally among the American people, lawmakers have once again thrown out the opening salvo in efforts to legislate against them this week with the “Do Not Disturb Act.” Unfortunately, these efforts appear to be broadly targeting all calls, including those you may want to receive from your credit union alerting you to fraud, a package delivery person or utility service providers among many other callers, with must-know...
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Jan 19, 2024 | 
jdsupra.com | Leah Dempsey |Zachary S. Pfister
The Consumer Financial Protection Bureau (CFPB) released a long-anticipated notice of proposed rulemaking on Jan. 17 that would fundamentally alter how overdraft services are provided by banks and credit unions. The CFPB is proposing to apply the rule only to what it deems “very large” banks and credit unions with assets equal to or exceeding $10 billion.
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Oct 25, 2023 | 
lexology.com | Leah Dempsey |David Cohen |Zachary S. Pfister |Annmarie Conboy- DePasquale |Joel L. Herberman
On Oct. 19, 2023, the Consumer Financial Protection Bureau (CFPB) released a Notice of Proposed Rulemaking (NPRM) on Personal Financial Data Rights, which would change the way financial institutions hold and distribute customer-generated data. The long-awaited proposal began under a November 2020 Advanced Notice of Public Rulemaking (ANPRM), and more recently, the CFPB convened a Small Business Review Panel (SBREFA) for this rulemaking on Feb. 1, 2023.
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Sep 6, 2023 | 
lexology.com | Leah Dempsey |Zachary S. Pfister |Rosemary Becchi |Annmarie Conboy- DePasquale |Geoffrey G. Burr
On Aug. 30, 2023, the Department of Labor (DOL) a Notice of Proposed Rulemaking (NPRM) about employer obligations related to overtime pay. The NPRM would put significant new burdens on a variety of industries, financial institutions and other businesses to offer overtime pay (time-and-a-half) to a much larger portion of their employees. The proposal is similar to a 2016 rule promulgated by the DOL under the Obama administration that was ultimately held up by a federal court in Texas.
