Zachary S. Pfister

1 week ago | jdsupra.com | David Dorsey |Zachary S. Pfister |Adam Steinmetz

The Medicare drug price negotiation provision in the 2022 Inflation Reduction Act treats small molecule drugs and biological products differently. For small molecules, drug price negotiations can start seven years after Food and Drug Administration (FDA) approval, with the negotiated price taking effect in year nine after FDA approval. For biological products, negotiations start at 11 years, and the negotiated price can take effect in year 13, after FDA approval.

2 months 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).

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.

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.

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.