Food, Drug and Cosmetic Act

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 25, 2013

Pro Te Solutio - Vol. 6 No. 1 February 2013

by Hemant Gupta, Keishunna Randall, Travis Swearingen | Butler, Snow, O'Mara, Stevens and Cannada,... on 5/22/2013

In This Issue: - Can Experts Testify as to the Ethics or State of Mind of Corporate Defendants? - Patent Reform for Biotech Companies - United States v. Caronia and its Implications for Off-Label...more

Update: FDA Regulation of Marijuana “Medibles” Presents Challenges and Uncertainty for Marijuana-based Food Manufacturers and...

by Fuerst Ittleman David & Joseph, PL on 5/21/2013

As we recently reported, federal regulators have continued to take measures aimed at stymieing the growth of the marijuana industry. Medical marijuana is now legal in over 18 states and, in November 2012, voters in Colorado...more

FDCA Express Preemption Victory in Benecol Misbranding Class Action

by Maya Ingram, Claudia Vetesi | Morrison & Foerster - Private Surgeon... on 5/17/2013

A recent Third Circuit case brings good news for defendants making express preemption arguments under the Food, Drug and Cosmetic Act (FDCA) in misbranding class actions. Last week, the court affirmed the dismissal of a...more

"Ranbaxy Resolves Criminal and Civil Charges Through Record Settlement"

by John T. Bentivoglio, Jennifer L. Bragg, Maya Florence, Michael K. Loucks, Gregory M. Luce | Skadden, Arps, Slate, Meagher & Flom LLP on 5/15/2013

Executive Summary - On May 13, 2013, generic drug manufacturer Ranbaxy USA Inc. (Ranbaxy), a subsidiary of Indian generic drug manufacturer Ranbaxy Laboratories Limited, pled guilty to seven felony charges as part of a...more

Congress Drafts Compounding Legislation -- Defines Compounded Drugs as "New Drugs" Under the FFDCA and Creates Bright Line Between...

by Elinor Hart, Rachael G. Pontikes | Duane Morris LLP on 4/30/2013

In the wake of the New England Compounding Center meningitis outbreak, the federal government has actively pushed for greater legislative oversight over compounding pharmacies. On April 26, 2013, the U.S. Senate Committee on...more

Product Liability Update - April 2013

by Foley Hoag LLP on 4/23/2013

In This Issue: - United States Supreme Court Holds Class Certification Improper Absent Showing Plaintiffs’ Damages Can Be Measured on a Classwide Basis through Use of a Common Methodology that Is Consistent with...more

Compounding Animal Drugs from Bulk Ingredients

by Duane Morris LLP on 4/17/2013

Recent public discussion about the federal role in regulating compounding pharmacies has focused on compounded drugs for human use. Compounded drugs are also vital to companion animal health (like pets). In the world of...more

Q&A With Carlton Fields' Gregory Cesarano

by Gregory Cesarano | Carlton Fields on 4/16/2013

At Carlton Fields, Greg Cesarano focuses his practice on defense of corporations and manufacturers in products liability and commercial claims. He also leads Carlton Fields’ products and toxic tort liability practice group,...more

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

Years Later, PCA Employees Indicted

by Steve Kluting | Varnum LLP on 4/15/2013

I had the following email exchange earlier this year with a concerned client: Client (in late January 2013): "Hi Steve, I was wondering if you knew of any cases where employees were prosecuted for not following...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

A Narrow Exception To The Mensing Preemption Defense

by Erin M. Bosman, Jeffrey M. David, James W. Huston, Julie Y. Park | 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

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

Howard v. Zimmer: Negligence Per Se Based on Violations of the FDCA—Blurring the Line Between Parallel Claims and Preemption

by Erin M. Bosman, James W. Huston, Joanna Simon | Morrison & Foerster LLP on 3/28/2013

Last week in Howard v. Zimmer, — P.3d —, 2013 WL 1130759 (Okla. 2013), the Oklahoma Supreme Court held that a plaintiff can assert a negligence per se claim against a medical device manufacturer based on the manufacturer’s...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

FDA Emphasizes Patient-Specific Prescriptions

by Elinor Hart, Rachael G. Pontikes | Duane Morris LLP on 3/21/2013

On March 7, 2013, the United States Food and Drug Administration (FDA) issued a warning letter to compounding pharmacy Medi-Fare Drug & Home Health Center (Medi-Fare Drug), taking the FDA's most aggressive position to date...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

Mind the Gap: Sixth Circuit Finds Room for Suit Against Generic Manufacturers After Mensing

by Erin M. Bosman, Jeffrey M. David, James W. Huston, Julie Y. Park | Morrison & Foerster LLP on 3/15/2013

Yesterday, the Sixth Circuit issued its decision in Fulgenzi v. PLIVA, Inc., a case involving a state law claim for failure to warn against a generic drug manufacturer. Case No. 12-3504 (6th Cir. March 13, 2013). The court...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

Ninth Circuit Affirms Prosecution for Off-label Marketing

by Lane Powell PC - White Collar Criminal... on 3/13/2013

Over the past two years, courts began to recognize that at least some off-label marketing is protected lawful commercial speech under the First Amendment. Specifically, the Second Circuit in New York in a case called United...more

When Food Production Leads to Prosecution

by Jeffrey B. Coopersmith, Chip English, David Ernst, Nicholas Kampars | Davis Wright Tremaine LLP on 3/7/2013

Over the last few weeks, two big stories have made headlines in the food industry. Beginning in early February, news media across Europe began reporting that food products tested in several European countries contained...more

Preemption: The Cure for the Common Claim?

by William Tarantino | Morrison & Foerster - Private Surgeon... on 3/1/2013

Although the landscape of the Federal Food Drug and Cosmetic Act (FDCA) preemption of private Surgeon General class action claims continues to shift under our feet in California, first with POM and recently with this case,...more

FDA Issues Supplemental Notice of Proposed Rulemaking and Draft Guidance Regarding Inclusion of Pediatric Subpopulation...

by King & Spalding on 2/27/2013

On February 19, 2013, FDA issued a supplemental notice of proposed rulemaking in the Federal Register, re-proposing amendments regarding information about pediatric subpopulations that must be submitted for certain medical...more

Preemption Still Has Teeth: The FDCA Keeps California False Advertising Claims at Bay in Pom Wonderful Suit

by Alexis Amezcua | Morrison & Foerster - Private Surgeon... on 2/15/2013

As we have noted in prior posts (FDCA, POM, preemption), the Food, Drug, and Cosmetic Act (“FDCA”) can provide a powerful tool to food companies that are hit with claims about their labeling. Yesterday, Judge Otero in the...more

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