DOJ Signals Intent to Increase Antitrust Scrutiny of Information Sharing
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- On February 2, 2023, the Principal Deputy Assistant Attorney General for the U.S. Department of Justice’s (DOJ) Antitrust Division, Doha Mekki, announced that the DOJ was withdrawing three policy statements outlining safe harbors for information sharing in the healthcare industry, and suggested that DOJ’s... ›
FTC Issues Updated Health Products Claims Guidance
By: Stacy Cline Amin, Julie Y. Park, Brigid DeCoursey Bondoc and Matt Robinson
On December 20, 2022, the Federal Trade Commission (FTC) issued its Health Products Compliance Guidance (“Health Products Guidance”). This is the first update in nearly 25 years to FTC’s guidance regarding advertising claims for dietary supplements, foods, over-the-counter drugs, and other health-related products. The... ›FDA Updates COVID-19 Testing Guidances
By: Stacy Cline Amin, Brigid DeCoursey Bondoc and Keunbong (KB) Do
Brandy Guarda, Regulatory Analyst in Washington, D.C., contributed to the drafting of this post. UPDATE : The Executive Office of the President announced on January 30, 2023, that the current administration plans to terminate the PHE declaration on May 11, 2023. This announcement does... ›CMS Reveals New Details on Medicare Drug Price Negotiation Program
By: Wendy C. Chow and Joe Adamczyk
For the first time in history, the Centers for Medicare and Medicaid Services (CMS) will engage in price negotiations with drug manufacturers for a subset of high-cost, name-brand drugs covered by Medicare. Pursuant to the Inflation Reduction Act (IRA), CMS took its first steps... ›EU MDR and IVDR Implementation: European Commission Publishes Full Proposal for Amending Transitional Regime
By: Wolfgang Schönig and Robert Grohmann
Following up on its announcement in the EU Employment, Social Policy, Health and Consumer Affairs Council ( EPSCO ) Meeting, the European Commission ( Commission ) released on January 6, 2023, a proposal ( Proposal ) to amend the transitional regime under the Medical... ›FDA Enables Pharmacies to Dispense Abortion-Inducing Mifepristone in Revised REMS
By: Stacy Cline Amin, Brigid DeCoursey Bondoc and Kate Driscoll
On January 3, 2023, the U.S. Food & Drug Administration (FDA) modified the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program to remove the in-person dispensing requirement and allow dispensing of mifepristone at certified retail pharmacies. FDA announced this forthcoming modification in December 2021... ›Privacy Litigation 2022 Year in Review: Biometric Information Privacy Act (BIPA)
By: Tiffany Cheung
In 2022, Illinois’s Biometric Information Privacy Act (BIPA) litigation was bustling. Defendants in BIPA cases ranged from pharmacies, insurance companies, and social media platforms to software companies, schools, and airlines. Even with the steady stream of opinions in 2022, key questions about BIPA’s scope... ›Congress Expands FDA Authority Over Cosmetics
By: Stacy Cline Amin, Brigid DeCoursey Bondoc and Matt Robinson
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was passed by the U.S. Congress as part of the omnibus Consolidated Appropriations Act enacted on December 29, 2022 and will grant the U.S. Food and Drug Administration (FDA) significant new authority to regulate cosmetics.... ›FDA Clarifies the Human Factors or Usability Information to Include in a Device Marketing Submission
By: Stacy Cline Amin, Brigid DeCoursey Bondoc and Keunbong (KB) Do
Brandy Guarda, Regulatory Analyst in Washington, D.C., contributed to the drafting of this post. If you are a device manufacturer, what human factors and usability information should you include in your marketing submission? What if your device has the same user interface as an existing... ›EU MDR and IVDR Implementation: Signs of Relaxing Transitioning Regime and Bridging Measures
By: Wolfgang Schönig and Robert Grohmann
Concerns over possible medical device shortages in the EU have led to two recent developments that will affect the implementation of the Medical Device Regulation [1] ( MDR ) and In Vitro Diagnostic Medical Device Regulation [2] ( IVDR ) : The EU Employment,... ›