Food, Drug and Cosmetic Act › Pharmaceutical

The Food, Drug and Cosmetic Act is a United States federal law enacted in 1938 in response to deaths following the legal marketing of a toxic elixir. The FDCA authorized the Federal Drug Administration to set standards for food and drug safety, and to conduct factory inspections. The FDCA was amended in 1962 to strengthen drug safety policies and implement new efficacy requirements. In 1976, Congress further amended the FDCA to apply safety and efficacy standards to new medical devices.

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News & Analysis as of May 21, 2013

Business Litigation Report -- April 2013

by Quinn Emanuel Urquhart & Sullivan, LLP on 4/15/2013

In This Issue: - Firm News: DoJ Star Healthcare Fraud Prosecutor Joins Washington, D.C. Office; and Quinn Emanuel Wins Top Honors at the Inaugural U.S. Benchmark Annual Awards - Main...more

The First Amendment and Off-Label Promotion: United States v. Caronia

by Quinn Emanuel Urquhart & Sullivan, LLP on 4/11/2013

For years, the U.S. Department of Justice has aggressively pursued and brought charges over “off-label promotions”—the promotion of drugs for uses that have not received FDA approval—by pharmaceutical manufacturers and their...more

Court Report -- April 1, 2013

by Sherri Oslick | McDonnell Boehnen Hulbert & Berghoff LLP on 4/1/2013

In This Issue: Millennium Pharmaceuticals Inc. v. Fresenius Kabi USA LLC et al.; Trustee's of the University of Pennsylvania v. St. Jude Children's Research Hospital; and Pfizer Inc. et al. v. Lupin Ltd. et al.....more

Case Brief: Federal Trade Commission v. Watson Pharmaceuticals

by Kwame Mensah | McDonnell Boehnen Hulbert & Berghoff LLP on 3/26/2013

[Ed. The Supreme Court heard oral argument today in Federal Trade Commission v. Watson Pharmaceuticals. While Patent Docs will provide analysis regarding the oral argument in a subsequent post, we provide the following...more

Court Upholds Executive’s Conviction Stemming from Off-Label Drug Promotion

by Christopher R. Hall, Gregory G. Schwab | Saul Ewing LLP on 3/25/2013

The U.S. Court of Appeals for the Ninth Circuit has upheld the wire fraud and misbranding convictions and sentence of InterMune Inc. founder W. Scott Harkonen. United States v. Harkonen, No. 11-10209 (9th Cir. March 4, 2013)....more

"Complex Mass Tort Product Liability Alert: Supreme Court Hears Oral Argument Regarding Scope of Generic Drug Preemption"

by John Beisner, Sheila Birnbaum, Mark Cheffo, Steven Napolitano | Skadden, Arps, Slate, Meagher & Flom LLP on 3/19/2013

Today, the Supreme Court of the United States held oral argument in Mutual Pharmaceutical Co. v. Bartlett, a follow-up to its landmark ruling in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), which addressed federal...more

Two New Developments in First Amendment Challenges to Off-Label Promotion: What's Next?

by King & Spalding on 3/14/2013

Following the Second Circuit’s marquee First Amendment ruling in the Caronia case, two recent developments demonstrate a shift in the battleground for First Amendment challenges to the prohibition on off-label promotion under...more

Second Circuit Vacates Pharmaceutical Misbranding Conviction on Free Speech Grounds

by John L. Brownlee, William F. Gould, Timothy J. Taylor | Holland & Knight LLP on 2/1/2013

After two years of deliberation, the U.S. Second Circuit Court of Appeals has finally issued its decision in United States v. Caronia, holding that the government cannot prosecute pharmaceutical manufacturers or their...more

FDA Will Not Appeal Second Circuit Decision in U.S. v. Caronia

by Ellyn L. Sternfield | Mintz Levin - Health Law on 1/30/2013

After the Second Circuit’s split decision in U.S. v. Caronia, holding that truthful off-label marketing is protected under the First Amendment and thus cannot be prosecuted under the misbranding provisions of the Food Drug...more

Second Circuit Declares Off-Label Promotion Ban Unconstitutional: Implications for False Claims Act Defendants

by Aileen Mcgill | Patterson Belknap Webb & Tyler LLP on 1/17/2013

On December 3, 2012, the United States Court of Appeals for the Second Circuit held that the First Amendment protects pharmaceutical companies who truthfully promote the lawful, off-label use of prescription drugs from...more

Telling People They Can Use A Drug In A Way Different Than How The FDA Says They Can Use A Drug Is Not A Crime, Says the Second...

by Matthew G. Kaiser | The Kaiser Law Firm PLLC on 1/3/2013

Alfred Caronia was a sales rep for a pharmaceutical company. And, despite what you might think by reading some of the literature, being a pharmaceutical sales rep is not a crime. It's even more emphatically not a crime after...more

Second Circuit Vacates Off-Label Promotion Conviction on First Amendment Grounds in U.S. v. Caronia

by King & Spalding on 12/22/2012

On December 3, 2012, a panel of three judges on the U.S. Court of Appeals for the Second Circuit overturned the November 2009 conviction of Alfred Caronia for conspiracy to introduce a misbranded drug into interstate commerce...more

Second Circuit Jettisons Criminal Conviction for Pharma Rep Convicted for Off-Label Promotion

by Christopher R. Hall, Gregory G. Schwab | Saul Ewing LLP on 12/20/2012

On December 3, 2012, the United States Court of Appeals for the Second Circuit overturned the conviction of a pharmaceutical sales representative convicted for misbranding in violation of the federal Food, Drug and Cosmetic...more

IRS Releases Final Rule on Medical Device Tax

by King & Spalding on 12/18/2012

Last week, the IRS and the Treasury Department published final regulations regarding the medical device excise tax under § 4191 of the Internal Revenue Code (IRC). IRC § 4191, which was enacted by the Health Care and...more

Off-Label Marketing Questioned as a Viable Criminal Theory – But Stay Tuned

by Jeffrey L. Bornstein, Michael R. Gordon, Leanne E. Hartmann, Michael H. Hinckle, Steven M. Kowal, Megan C. Lambert, Suzan Onel, Michael D. Ricciuti, Mark A. Rush, Paul W. Shaw | K&L Gates LLP on 12/17/2012

On December 3, 2012, a divided Second Circuit held in United States v. Caronia (“Caronia”) that the misbranding provisions of the Federal Food, Drug, and Cosmetic Act (“FDCA”) do not criminalize “the truthful off-label...more

Advertising News & Analysis – December 13, 2012

by David G. Adams, Emilio W. Cividanes, Todd A. Harrison, Stuart P. Ingis, Jeffrey D. Knowles, Claudia A. Lewis, Amy Ralph Mudge, Jonathan L. Pompan, Andrew D. Price, Matthew R. Rabinowitz, more +Randal M. Shaheen, Ralph S. Tyler | Venable LLP on 12/17/2012

In this issue: - It’s Easier Being Green - Off-Label Marketing Protected by First Amendment - Understanding New Restrictions on Advertising GI Bill Benefits - FTC Looks at "The Big Picture" - Upcoming...more

United States v. Caronia: Second Circuit Rules Manufacturers Cannot Be Criminally Prosecuted for Off-Label Promotion of Drugs...

by Fuerst Ittleman David & Joseph, PL on 12/17/2012

On December 3, 2012, the United States Court of Appeals for the Second Circuit issued a landmark decision in United States v. Caronia, holding that “the government cannot prosecute pharmaceutical manufacturers and their...more

Second Circuit Rules That Certain Speech Regarding the Off-Label Use of Drugs Is Protected Under the U.S. Constitution

by Stuart M. Gerson, David C. Gibbons, Wendy C. Goldstein, Daniel G. Gottlieb, Benjamin S. Martin, Natasha F. Thoren | Epstein Becker & Green, P.C. on 12/13/2012

In a long-awaited decision, on December 3, 2012, a divided panel (2–1) of the U.S. Court of Appeals for the Second Circuit vacated the conviction of Alfred Caronia, a former pharmaceutical sales representative for Jazz...more

Short Wins - Off-Label Drug Use And the First Amendment In The Second Circuit; Machine Guns And Grenades In The Eighth Circuit

by The Kaiser Law Firm PLLC on 12/12/2012

It's an odd week for wins in the federal appellate courts. The Second Circuit ruled that the First Amendment protects (some kinds of) promotional activity for off-label use of drugs. Any time the First Amendment is...more

Second Circuit Rules that Pharma Rep's Promotion of Drug for Off-Label Use is Protected Speech

by S. Jeanine Conley | BakerHostetler on 12/11/2012

The Second Circuit's December 3, 2012 decision in United States v. Caronia, No. 09-5006-CR, could cause a sea change in the growing number of prosecutions brought by the government to prevent the off-label promotion of drugs...more

Does Misdemeanor Misbranding Survive Caronia?

by Jonathan Sack | Morvillo Abramowitz Grand Iason & Anello P.C.... on 12/11/2012

The Court of Appeals for the Second Circuit sent shockwaves through the pharmaceutical industry with its decision in United States v. Caronia. Alfred Caronia was a pharmaceutical sales representative convicted of a...more

Second Circuit Rules Off-Label Marketing is Protected by First Amendment

by David G. Adams, Todd A. Harrison, Claudia A. Lewis, Matthew R. Rabinowitz, Ralph S. Tyler | Venable LLP on 12/10/2012

On December 3, 2012, the United States Court of Appeals for the Second Circuit, in a 2-1 opinion, vacated the criminal conviction of a pharmaceutical sales representative for promoting off-label uses of a particular drug....more

Second Circuit Holds that Criminal Penalties for Pharmaceutical Sales Representative’s Off-Label Promotion Violate the First...

by Robin A. Linsenmayer | Orrick, Herrington & Sutcliffe LLP on 12/8/2012

On December 3, 2012, the United States Court of Appeals for the Second Circuit issued an opinion that stands to transform the regulatory landscape in which pharmaceutical and medical device companies operate. In recent...more

Second Circuit Holds Food, Drug and Cosmetic Act Does Not Prohibit Off-Label Promotion

by Dechert LLP on 12/7/2012

In a significant blow to the U.S. government’s enforcement efforts against the pharmaceutical industry, a panel of the Second Circuit overturned the conviction of a pharmaceutical sales representative for conspiracy to...more

In Landmark Decision, Second Circuit Reverses Conviction For Off-Label Promotion

by Anastasia (Ana) K. Anderson, Renee M. Howard, Joel R. Levin, David B. Robbins | Perkins Coie on 12/7/2012

On December 3, 2012, in United States v. Caronia, a three-judge panel of the Second Circuit reversed a drug salesperson’s conviction for conspiracy to introduce a misbranded drug into interstate commerce, a misdemeanor...more

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