Insights on Life Sciences
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On January 27, the US Department of Health and Human Services Office of Inspector General (OIG) issued a Special Advisory Bulletin providing significant guidance for pharmaceutical manufacturers offering prescription drugs through direct-to-consumer (DTC) programs to patients enrolled in federal health care programs.
Headlines that Matter for Companies and Executives in Regulated Industries
Headlines that Matter for Companies and Executives in Regulated Industries
Welcome to the January 2026 issue of “As the (Customs and Trade) World Turns,” our monthly newsletter where we compile essential updates from the customs and trade world over the past month. We bring you the most recent and significant insights in an accessible format, concluding with our main takeaways — aka “And the Fox Says…” — on what you need to know.
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) just issued a joint statement outlining 10 “Guiding Principles” for using artificial intelligence (AI) in drug development.
With 2026 underway, the AFS Health Care team highlights some of the most pressing legal issues facing the health care industry this year.
Headlines that Matter for Companies and Executives in Regulated Industries
The US Food and Drug Administration (FDA) issued an inspectional observation (Form FDA 483) to a Texas med spa, Pure Indulgence Aesthetics, citing Drug Supply Chain Security Act (DSCSA) violations for dispensers.
Headlines that Matter for Companies and Executives in Regulated Industries
Last month, a federal court in Maine halted the US Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) 340B Rebate Model Pilot Program in its tracks — a mere four days before it was to go into effect.
For the past several years, the use of contract sales forces by pharmaceutical and device manufacturers and other suppliers has been under a heightened enforcement spotlight.
Life Sciences Industry Group Co-Leader Stephanie Trunk was quoted on Medicare’s updated drug price negotiation program under the Inflation Reduction Act being implemented in 2026.
Headlines that Matter for Companies and Executives in Regulated Industries
Public-facing debates over pharmaceutical drugs and life sciences products are as pronounced as ever. Although the ongoing scuffle over Tylenol has received the most attention, similar controversies abound. Just last month, Aurinia Pharmaceuticals filed a defamation complaint against a now-resigned US Food and Drug Administration (FDA) official over critical statements made about one of its drugs.
On December 12, the Eleventh Circuit heard the much-anticipated oral arguments in United States ex rel. Zafirov v. Florida Medical Associates LLC concerning the constitutionality of the False Claims Act’s (FCA) qui tam provisions.
Welcome to the December 2025 issue of “As the (Customs and Trade) World Turns,” our monthly newsletter where we compile essential updates from the customs and trade world over the past month. We bring you the most recent and significant insights in an accessible format, concluding with our main takeaways — aka “And the Fox Says…” — on what you need to know.
Headlines that Matter for Companies and Executives in Regulated Industries
Headlines that Matter for Companies and Executives in Regulated Industries
Judge Kathryn Kimball Mizelle’s ground-breaking decision in Zafirov v. Florida Medical Associates LLC and Justice Clarence Thomas’ solo dissent in US ex rel. Polansky v. Executive Health Resources Inc. have revived what many had viewed as a settled constitutional question.
On November 21, the Centers for Medicare & Medicaid Services (CMS) issued a final rule announcing changes for Medicare payments for hospital outpatient services under the Hospital Outpatient Prospective Payment System (HOPPS).
After issuing the Physician Fee Schedule (PFS) on October 31, the Centers for Medicare & Medicaid Services (CMS) has now published templates for manufacturers to utilize when complying with new requirements regarding the submission of reasonable assumptions related to their average sales price (ASP) calculations. CMS also mandates that manufacturers submit Bona Fide Service Fee (BFSF) certification or warranty letters for new or renewal contracts dated January 1, 2026, or later that contain BFSFs with quarterly ASP.
Headlines that Matter for Companies and Executives in Regulated Industries
Now in its 13th year, the Patent Trial and Appeal Board (PTAB) remains a central forum for resolving patent validity disputes.
Headlines that Matter for Companies and Executives in Regulated Industries
Welcome to the November 2025 issue of “As the (Customs and Trade) World Turns,” our monthly newsletter where we compile essential updates from the customs and trade world over the past month. We bring you the most recent and significant insights in an accessible format, concluding with our main takeaways — aka “And the Fox Says…” — on what you need to know.