Manufacturers, Federal Food Drug and Cosmetic Act (FFDCA), Generic Drugs

FTC Alleges Improper Orange Book Listing of Drug Delivery Device Patents

Morrison & Foerster LLP on 11/14/2023

In the latest attempt to promote generic drug competition and reduce drug prices, and consistent with broader efforts to enforce the antitrust laws more aggressively, the Federal Trade Commission (FTC) announced on November...more

Mintz IRA Update — Basics of the Medicare Drug Price Negotiation Program

Mintz - Health Care Viewpoints on 9/21/2023

The Inflation Reduction Act (“IRA”) was passed just over a year ago with a goal of lowering high drug costs for Medicare beneficiaries and reducing costs incurred by Medicare. A central piece to achieving the IRA’s goal of...more

Not Prescription, Not Merely Over the Counter: FDA Proposes a Novel Category of Drugs

Dechert LLP on 10/19/2022

In June of this year, FDA announced a proposed rule that would permit approval for nonprescription drug products with an Additional Condition for Nonprescription Use—a category of nonprescription drugs where FDA determines...more

Pharmaceutical Manufacturer Pays $7.9 Million to Resolve Allegations that it Caused the Submission of Over-the-Counter Drugs to...

Mintz - Health Care Viewpoints on 9/21/2022

On September 15, 2022, the Department of Justice (DOJ) announced a $7.9 million settlement with generic manufacturer Akorn Operating Company LLC (Akorn) to resolve allegations that Akorn caused the submission of...more

Proposed Antitrust Legislation Targets Pharmaceutical Industry, Would Grant FTC More Powers

Morgan Lewis - As Prescribed on 8/16/2021

A bipartisan group of lawmakers in the US House of Representatives’ Judiciary Antitrust Subcommittee recently voted three bills out of committee that target the pharmaceutical industry practices of so-called “reverse...more

Beyond COVID: House Committee Advances Several FDA-Related Bills

Mintz - Health Care Viewpoints on 7/23/2020

On Wednesday, July 15, the House Energy and Commerce (E&C) Committee advanced several bills to the House floor that demonstrate continued interest in health policy matters other than the COVID-19 pandemic. The Fairness in...more

Massachusetts Creates First-In-Nation Recklessness Standard For Claims Against Brand-Name Drug Manufacturers By Users Of Generics

Foley Hoag LLP on 3/22/2018

In a case of first impression, the Massachusetts Supreme Judicial Court (“SJC”) held in Rafferty v. Merck & Co., No. SJC-12347 (Mar. 16, 2018), that the manufacturer of a brand-name prescription drug can be liable for...more

New FDA Draft Guidance on Updates to Certain Generic Labeling

Cozen O'Connor on 7/18/2016

On July 8, 2016, the U.S. Food and Drug Administration released draft guidance amending the process for manufacturers to update labeling of generic drugs in situations where the reference drug labeling has been withdrawn for...more

A Narrow Exception To The Mensing Preemption Defense

Morrison & Foerster LLP on 4/8/2013

The Sixth Circuit recently held that a failure-to-warn claim could proceed against a generic manufacturer that had failed to timely follow the brand-name label. Fulgenzi v. Pliva Inc., Case No. 12-3504 (6th Cir. March 13,...more

Stengel Tangles MDA Preemption: Ninth Circuit Decision Creates Split on Buckman Preemption of Post-Market Reporting Requirements

Morrison & Foerster LLP on 1/15/2013

Last week the Ninth Circuit created a new state-law cause of action against medical device manufacturers: “failure to warn the FDA.” The en banc opinion in Stengel v. Medtronic Inc., __ F.3d __, 2013 WL 106144, 13 C.D.O.S....more

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