News & Analysis as of

Generic Drugs The United States Food and Drug Administration Manufacturers

Eleventh Circuit Affirms Preemption of HRT Complaint

by Reed Smith on

Today, December 1, 2017, is the birthday of Gilbert O’Sullivan, who scored a hit back in 1972 with “Alone Again, Naturally,” the saddest song we can think of this side of Albinoni’s Adagio. That is fitting, given our...more

FTC Hosts Workshop – “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics”

by Mintz Levin on

On Wednesday, November 8, 2017 the Federal Trade Commission (FTC) hosted a workshop seeking to explore the general question of why the cost of prescription drugs has risen greatly in recent history. The Workshop was framed...more

Innovator Liability Fails Again

by Reed Smith on

As we discussed at the time, the MDL-wide innovator liability appeals in In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917 (6th Cir. 2014), resulted in rulings under more than 20 states’ laws...more

Non-Existent Duty to Warn of Mensing Not Enough to Get Around Mensing Preemption

by Reed Smith on

Earlier this week, we discussed how the presentation of the federal question of express preemption from the face of a complaint can lead to removal. Part of why the defendant drug or device manufacturer may prefer federal...more

Trump’s Nominee for FDA Commissioner Likely Dooms Generic Drug Labeling Rule

President Trump recently announced his intent to nominate a new commissioner of the U.S. Food and Drug Administration (FDA), likely sealing the fate of FDA’s proposed generic drug labeling rule. The proposed rule would give...more

Three Dozen States Sue Makers of Opioid Addiction Treatment Medications for Antitrust

by Foley & Lardner LLP on

With opioid abuse continuing to dominate national headlines, manufacturers of opioid overdose medications are facing intense scrutiny over pricing practices that threaten (or those perceived as threatening) public...more

BioPharma Patents Quick Tips & News – July 2016

U.S. FDA Orange Book Refresher Edition - What types of patents can be listed on the FDA’s Orange Book? Listable = Pharmaceutical-related patents are allowed in the FDA’s Orange Book only if they’re “composition” or...more

Lowered Risk for Inventors Who Use Contract Product Development or Manufacturing

by McNair Law Firm, P.A. on

On July 11, in The Medicines Company v. Hospira, Inc., the Federal Circuit held that a contract manufacturer's sale of manufacturing services to an inventor did not constitute a commercial sale of the patented invention for...more

FDA Offers Draft Guidance for Generic Drug Label Updates

by Faegre Baker Daniels on

In July 2016, the U.S. Food and Drug Administration (FDA) published draft guidance outlining when drug companies should update a generic drug’s label after the brand name drug on which the generic is based has been withdrawn...more

New FDA Draft Guidance on Updates to Certain Generic Labeling

by Cozen O'Connor on

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

Generic vs. Branded Liability: Mensing Holds Sway Until FDA Completes Rulemaking

by Latham & Watkins LLP on

FDA’s delay on the final version of generic labelling rules until April 2017 means both branded and generic drug manufacturers face continued uncertainty. The U.S. Food and Drug Administration (FDA) recently announced it...more

FDA Biosimilars Guidance Not Conducive To Preemption

by Reed Smith on

The FDA recently released draft guidance concerning the labeling of biosimilar products (analogous in the biologic context to generic drugs). It’s called, not surprisingly “Labeling for Biosimilar Products Guidance for...more

FDA Proposed Rule in Flux?

by Morrison & Foerster LLP on

On Tuesday, the U.S. Food and Drug Administration (FDA) announced that it has reopened the comment period for its proposed rule on generic drug labeling. It has also scheduled a day-long public meeting to hear comments and...more

A Narrow Exception To The Mensing Preemption Defense

by Morrison & Foerster LLP on

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

Breaking Down The Bartlett Oral Argument

by Morrison & Foerster LLP on

The U.S. Supreme Court has heard oral argument in the much-anticipated Mutual Pharmaceuticals v. Bartlett case, No. 12-142 (on appeal from the First Circuit Bartlett v. Mutual Pharms. Co., 678 F.3d 30 (1st Cir. 2012)). The...more

Supreme Court Oral Argument in FTC v. Actavis

The Supreme Court heard oral argument in Federal Trade Commission v. Actavis (the caption for what was Federal Trade Commission v. Watson Pharmaceuticals, Inc. in the 11th Circuit opinion below) last Monday, with Deputy...more

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

by Morrison & Foerster LLP on

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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