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Government Regulation

Trump Administration Revives Possibility of MFN Drug Pricing: Key Implications for the Life Sciences Industry

May 15, 2025 | Posted by Rachel Baron; Wynne Leahy; Carlo Felizardo; Jonathan Phillips; John D.W. Partridge; Katlin McKelvie; Topic(s): FDA; Government Regulation; Trends and Insights

On May 12, 2025, President Trump signed an Executive Order (“EO” or “Order”) “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients” aimed at significantly reducing U.S. prescription drug prices by aligning them with the lowest prices paid by other developed nations.  According to the EO, drug manufacturers “deeply discount their products to access foreign markets and subsidize that decrease through enormously high prices in the United States.”  Seeking to rectify this “egregious imbalance,” the EO announced the following policy: “Americans must therefore have access to the most-favored-nation price for these products… [and] should drug manufacturers fail to offer American consumers the most-favored-nation lowest price, [the] Administration will take additional aggressive action.”

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Navigating the Impact of Emergency Tariffs on Biotech Manufacturing with Chinese Counterparties

March 10, 2025 | Posted by Samantha Sewall; Lindsay Bernsen Wardlaw; Adam Smith; Branden C. Berns; Topic(s): Government Regulation; International Trade; Manufacturing; Trends and Insights

The recent imposition of emergency tariffs on products from China and Hong Kong has raised significant concerns for biotech companies, particularly those considering or currently engaged in manufacturing contracts with Chinese entities. This post aims to provide an overview of the recent emergency tariffs targeting China and their potential implications for the biotech industry.

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FDA in Flux: What Life Science Companies Should Expect as the Agency Undergoes Staffing Changes

March 4, 2025 | Posted by Katlin McKelvie; Carlo Felizardo; Topic(s): FDA; Government Regulation; Trends and Insights

The beginning of the second Trump administration has been marked by significant—and often sudden—efforts to shrink the federal workforce and replace agency leadership to establish and deliver on a new set of priorities. In the past weeks, the administration has pursued a deferred resignation program,[1] terminated employees both in leadership and on probationary status,[2] and announced plans for a forthcoming government-wide reduction in force.[3] The U.S. Food and Drug Administration (FDA) has not been immune to these changes.

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Charlotte Jacobsen

Jin Hee Kim

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