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Manufacturers › Enforcement › Prescription Drugs

Cozen O'Connor

Bipartisan Coalition of AGs Secures $720 Million Settlement with Opioid Manufacturers

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Virginia AG Jason Miyares, along with a bipartisan coalition of eight other AGs, announced a $720 million settlement with eight opioid drug manufacturers to resolve allegations that they contributed to the opioid epidemic....more

Goodwin

State Drug Transparency Laws - 2025 Update

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We previously reported on an uptick in the passage of state drug price transparency legislation. What follows is an update to that report. As of April 2025, approximately 23 states had passed drug price transparency laws....more

Foley & Lardner LLP

GLP-1 Drugs: FDA “Re-Confirms” Decision Removing Tirzepatide from the Drug Shortage List

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On December 19, 2024, the U.S. Food and Drug Administration (FDA) issued a Declaratory Order reevaluating and re-confirming that the tirzepatide drug shortage has been resolved. This order revoked and replaced FDA’s October...more

Gardner Law

FDA Drafts Guidance on Correcting “Misinformation”

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The U.S. Food and Drug Administration (FDA) recently released draft guidance on how and when medical device manufacturers and pharmaceutical companies can respond to misinformation about their products online. While not yet...more

Gardner Law

Navigating HIPAA and State Privacy Laws for Drug and Device Manufacturers

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The Health Insurance Portability and Accountability Act of 1996 as amended and implemented through regulations at 45 C.F.R. §§ 160 and 164 (“HIPAA”) regulates the privacy and security of health information. For drug and...more

Foley & Lardner LLP

FDA’s Final Rule on Direct-to-Consumer Advertising – Presentation of Risk Information

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In November 2023, the U.S. Food and Drug Administration (FDA) published its final rule (Rule) to amend its regulations concerning radio and television direct-to-consumer (DTC) advertisements (ads) for human prescription drugs...more

Gardner Law

New WA Privacy Law ‘Turns The Beat Around’ on Drug and Device Makers

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The Washington My Health My Data Act ("MHMDA") may not have been written by Earth, Wind, & Fire, but it is certainly poised to make medical device and pharmaceutical manufacturers move to a new beat like a classic disco hit....more

Sheppard Mullin Richter & Hampton LLP

FDA Issues First Untitled Letter of the Year to HCT/P Manufacturer

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On March 1, 2023, the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) published its first untitled letter of the year to Thomas Advanced Medical LLC (Thomas) for marketing...more

Gardner Law

Are you Ready for Inspection? Best Practices to “Survive” FDA Inspections

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Companies often come to Gardner Law when they feel anxious or unprepared for a visit from the Food and Drug Administration (FDA). Even experienced companies with strong quality systems sometimes need assistance to be fully...more

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