James W. Huston on Food and Drug Administration (FDA)

Launch of openFDA Increases Accessibility to Adverse Drug Event Reports

On June 2, 2014, the Food and Drug Administration launched openFDA, a program designed to improve access to publicly available data beginning with adverse event reports. While greater accessibility to adverse event reports...more

6/18/2014 / Adverse Events , Databases , Department of Health and Human Services (HHS) , FOIA , Food and Drug Administration (FDA) , openFDA , Pharmaceutical Industry , Prescription Drugs , Reporting Requirements , Transparency

$4 billion price tag? FDA's proposed generic drug labelling rule

An economic consulting group recently published findings that a Food and Drug Administration (FDA) proposed rule will increase annual healthcare costs by $4 billion. The FDA's proposal, announced in November 2013, will allow...more

3/14/2014 / Food and Drug Administration (FDA) , Generic Drugs , Labeling , Pharmaceutical Industry , Prescription Drugs

Goodbye to Generic Preemption? FDA Publishes Proposed Rule

Today, the U.S. Food and Drug Administration (FDA) published a long-awaited proposed rule in the Federal Register in an effort to “create parity” between brand-name and generic manufacturers for their labeling obligations. 78...more

11/14/2013 / Food and Drug Administration (FDA) , Generic , Pharmaceutical Industry , Preemption , Prescription Drugs

Jury Buys Plaintiff’s Argument That Drug Manufacturer Should Have Distributed Dear Doctor Letter Sooner, Without Prior FDA...

Dear Doctor letters were front and center in the just-tried case of Tietz v. Abbott Laboratories, Inc., et al., No. 12-L-002715. On Thursday, May 9, 2013, a Chicago jury returned a $2.2 million verdict in favor of the...more

5/16/2013 / Abbott Laboratories , Failure To Warn , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs

A Narrow Exception To The Mensing Preemption Defense

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

4/8/2013 / Failure To Warn , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Generic Drugs , Labeling , Manufacturers , PLIVA v Mensing , Preemption , SCOTUS

Breaking Down The Bartlett Oral Argument

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

4/5/2013 / Design Defects , Food and Drug Administration (FDA) , Generic Drugs , Manufacturers , Preemption , SCOTUS , Warning Labels

James W. Huston

Morrison & Foerster LLP

Popular Topics by This Author

Latest Posts › Food and Drug Administration (FDA)

Launch of openFDA Increases Accessibility to Adverse Drug Event Reports

$4 billion price tag? FDA's proposed generic drug labelling rule

Goodbye to Generic Preemption? FDA Publishes Proposed Rule

Jury Buys Plaintiff’s Argument That Drug Manufacturer Should Have Distributed Dear Doctor Letter Sooner, Without Prior FDA...

A Narrow Exception To The Mensing Preemption Defense

Breaking Down The Bartlett Oral Argument

James W. Huston

Morrison & Foerster LLP

Popular Topics by This Author

Latest Posts › Food and Drug Administration (FDA)

Launch of openFDA Increases Accessibility to Adverse Drug Event Reports

$4 billion price tag? FDA's proposed generic drug labelling rule

Goodbye to Generic Preemption? FDA Publishes Proposed Rule

Jury Buys Plaintiff’s Argument That Drug Manufacturer Should Have Distributed Dear Doctor Letter Sooner, Without Prior FDA...

A Narrow Exception To The Mensing Preemption Defense

Breaking Down The Bartlett Oral Argument

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