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Lois Sheng Liu

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In Healthcare Services

United States: HHS-OIG Issues Unfavorable Advisory Opinion on Physician Royalty Arrangements with Device Company

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In brief On May 18, 2026, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) released an unfavorable Advisory Opinion No. 26-10 (“AO 26-10”) addressing an arrangement proposed by an orthopedic medical technology company (the “Company”) that would compensate physician consultants (“HCPs”) through a percentage-of-sales royalty covering broad product lines (the “Arrangement”). OIG concluded that, while consulting and royalty arrangements are common in the medical device industry, this Arrangement presents a…

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In Pharmaceuticals & Biotech

United States: President Trump Tariffs on Patented Pharmaceuticals Under Section 232

by , , , , , , , , and 4 Mins Read

On April 2, 2026, President Trump issued a proclamation adjusting imports of patented pharmaceuticals and associated pharmaceutical ingredients, including active pharmaceutical ingredients (APIs). The action followed an investigation by the Secretary of Commerce under Section 232 of the Trade Expansion Act of 1962, which the proclamation states concluded that imports of patented pharmaceuticals and related inputs were being imported into the United States in such quantities and under such circumstances as to threaten to impair U.S. national…

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In Pharmaceuticals & Biotech

Manufacturing Site Divestitures: Best Practices for Successful Execution

by , , and 11 Mins Read

Pharmaceutical companies are increasingly outsourcing complex manufacturing activities to contract development and manufacturing organizations, or CDMOs. This enables pharmaceutical companies to streamline their operations and redeploy capital toward research and development activities. At the same time, the CDMO industry is booming, with many analysts predicting continued rapid growth. CDMOs need more capacity, and they need it quickly. As a result of these trends, many pharmaceutical companies are engaging in an increasing number of transactions in…

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In Healthcare Services

The U.S. Department of Health and Human Services  Issues Favorable Opinion on Healthcare Company’s Donations to Charitable Foundation

by and 5 Mins Read

In brief On September 11, 2025, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) released a favorable advisory opinion (“AO 25-10”), addressing a financial arrangement between a healthcare services company (the “Company”) and a non-profit, tax-exempt, charitable foundation (the “Foundation”), pursuant to which the Company helped establish and makes donations to the Foundation and the Foundation provides financial assistance to families of children receiving a particular type of behavioral…

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In Pharmaceuticals & Biotech

New White House Executive Order to Establish “Most-Favored-Nation” Drug Pricing

by , , , , , , , , , and 7 Mins Read

On May 12, 2025, the White House issued a wide-reaching Executive Order (“EO”) titled “Delivering Most Favored Nation Prescription Drug Pricing to American Patients” for the stated purpose of ensuring that American patients will have access to the most-favored-nation (“MFN”) price for prescription drugs and biologics.1 This EO came out about one month after the release of EO No. 14273 titled “Lowering Drug Prices by Once Again Putting Americans First” (April 15, 2025) which outlined…

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In Digital Health

Key Legal Trends in The United States For Healthcare And Life Sciences In 2024

by and 1 Min Read

In brief As we look back at 2023, we reflect on a year marked by significant developments in the legal framework governing the life sciences and healthcare industries in the US. These developments include the implementation of the Medicare Drug Price Negotiation Program under the Inflation Reduction Act; the rise of artificial intelligence in drug development and manufacturing; the evolving landscape of US Food and Drug Administration regulation and enforcement of laboratory-developed tests; and the…

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