MoFo Life Sciences

February 08, 2023 - Privacy + Data Security, Pharma, Healthcare, United States, Digital Health
FTC Brings First Enforcement Action of the Health Breach Notification Rule
By: Melissa M. Crespo
The Federal Trade Commission (FTC) has enforced its Health Breach Notification Rule (the “HBNR”) for the first time since it was enacted in 2009. On February 1, the FTC announced a first-of-its-kind proposed order (the “Order”) with digital health platform GoodRx Holdings Inc. (“GoodRx”),
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February 07, 2023 - FDA, Regulatory, Pharma, Healthcare, United States
Supreme Court Denies Review of Cost Sharing Assistance Program
By: Adam L. Braverman and Seth W. Lloyd
The U.S. Supreme Court recently declined to review a Second Circuit decision that blocked Pfizer from implementing a cost sharing assistance program. Pfizer had sought to cover out-of-pocket expenses for financially eligible Medicare patients who need tafamidis, the only approved drug by the Food
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January 30, 2023 - FDA, Regulatory, United States, Healthcare, Medical Devices + Diagnostics, Pharma
FTC Issues Updated Health Products Claims Guidance
By: 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
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January 20, 2023 - Healthcare, United States, Pharma, Litigation, Regulatory
CMS Reveals New Details on Medicare Drug Price Negotiation Program
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
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January 17, 2023 - FDA, Regulatory, United States, Pharma
FDA Enables Pharmacies to Dispense Abortion-Inducing Mifepristone in Revised REMS
By: 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
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December 14, 2022 - Intellectual Property, Pharma, Regulatory, European Union
Relabeling vs. Repackaging: CJEU Backs Drug Manufacturers’ Position Against Parallel Importers
By: Robert Grohmann
In two recent landmark decisions, Novartis v. Abacus (C ‑ 147/20) and Bayer v. kohlpharma (C-204/20), the Court of Justice of the European Union ( CJEU ) strengthened the position of drug manufacturers against repackaging practices of parallel importers. The court held that, based
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November 29, 2022 - FDA, Healthcare, Digital Health, Regulatory, Pharma, United States
CMS Publishes Final 2023 Medicare Physician Fee Schedule—Key Takeaways for Telehealth Companies
On November 1, 2022, the Centers for Medicare and Medicaid Services (CMS) published the final 2023 Medicare Physician Fee Schedule (“2023 Fee Schedule”). Although the 2023 Fee Schedule most notably sets the rates for Medicare services for the coming year, the rulemaking also traditionally includes
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November 17, 2022 - FDA, Healthcare, Digital Health, Regulatory, Pharma
FDA Clarifies ANDA Active Ingredient Sameness Evaluation in Draft Guidance
By: Brigid DeCoursey Bondoc
On November 8, 2022, FDA issued a draft guidance document on Sameness Evaluations in an ANDA — Active Ingredients (“Draft Guidance”). In the Draft Guidance, FDA indicated that the active ingredient’s chemical form will generally be the entire molecule, but it may also encompass
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August 25, 2022 - Pharma, Intellectual Property, Litigation
Last Week in the Federal Circuit (August 15 – August 19): The Court Rebuffs Patent Owner’s Attempt to Read Anda Application in Isolation
By: Brian R. Matsui
Our Federal Circuitry blog recently discussed the Court's decision in Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc. , No. 21-2342. You should read this case if: you have an ANDA case involving “actual, real-world evidence” that might conflict with what the ANDA says For our
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May 26, 2022 - United States, FDA, Healthcare, Pharma, Regulatory, Intellectual Property
Senators Call for Report on State of Psychedelic Research
Thanks to our Life Sciences Transactions + Licensing Group, including Matthew Karlyn, Mai Zymaris, and Hannah Koo, for contributing to this post. Earlier this month, Senators Brian Schatz (D-HI) and Cory Booker (D-NJ) sent a letter to the National Institutes of Health (NIH) and
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Topic Archives: Pharma

FTC Brings First Enforcement Action of the Health Breach Notification Rule

By: Melissa M. Crespo

Supreme Court Denies Review of Cost Sharing Assistance Program

By: Adam L. Braverman and Seth W. Lloyd

FTC Issues Updated Health Products Claims Guidance

By: Julie Y. Park, Brigid DeCoursey Bondoc and Matt Robinson

CMS Reveals New Details on Medicare Drug Price Negotiation Program

FDA Enables Pharmacies to Dispense Abortion-Inducing Mifepristone in Revised REMS

By: Brigid DeCoursey Bondoc and Kate Driscoll

Relabeling vs. Repackaging: CJEU Backs Drug Manufacturers’ Position Against Parallel Importers

By: Robert Grohmann

CMS Publishes Final 2023 Medicare Physician Fee Schedule—Key Takeaways for Telehealth Companies

FDA Clarifies ANDA Active Ingredient Sameness Evaluation in Draft Guidance

By: Brigid DeCoursey Bondoc

Last Week in the Federal Circuit (August 15 – August 19): The Court Rebuffs Patent Owner’s Attempt to Read Anda Application in Isolation

By: Brian R. Matsui

Senators Call for Report on State of Psychedelic Research