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... more +
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. less -
News & Analysis as of

Senate HELP Committee Approves Mental Health, Opioid Abuse, Drug Scheduling Legislation

On September 30, 2015, the Senate Health, Education, Labor, and Pensions (HELP) Committee approved the following bipartisan legislation: S. 799, the Protecting Our Infants Act (to combat the rise of prenatal opioid abuse and...more

Update on FDA’s Approach to Labeling Biosimilars Like Generics

The FDA approved label for the first U.S. biosimilar, Sandoz’s Zarxio, has raised concerns. Zarxio was launched on September 3, 2015 with a label that does not state that the product was approved as a biosimilar to Amgen’s...more

The FDA Tiptoes – and Congress Splashes Into – the 21st Century

Here are a couple of non-litigation related matters that we thought our readers need to know about. First, the FDA. We’ve pointed out before that the FDA’s “intended use” regulations for drugs (21 C.F.R. §201.128) and...more

Making Sense of the Daubert and Summary Judgment Orders in A Metal-on-Metal Hip Implant Bellwether Case

We have not posted for a while—that day job can really get in the way sometimes—so we agreed to tackle the ridiculously long decision in Christiansen v. Wright Med. Tech. Inc., MDL No. 2329, 1:13-cv-297-WSD, 2015 U.S. Dist....more

"The Future of Government Regulation, Enforcement of Off-Label Promotion"

Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...more

In Case of Good Judge, Break Glass – Implied Impossibility Preemption in Cases Involving §510(k) Cleared Medical Devices

We have alluded on a couple of occasions to the likelihood that the recent generic drug implied impossibility preemption decisions in PLIVA v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S....more

Pharma and Medical Device Industry Victory in Off-Label Marketing Decision

The U.S. District Court for the Southern District of New York recently held that the FDA may not constitutionally bring a misbranding action based on truthful and non-misleading off-label promotion of an FDA-approved drug,...more

It’s Déjà Vu All Over Again: FDA Sued Again in Off-Label Promotion Case

To quote the late Yogi Berra, it must feel like déjà vu all over again for the Food and Drug Administration (FDA) (or, if you prefer, Crosby, Stills, Nash & Young’s song, “Déjà Vu” (“We have all been here before”)). Fresh off...more

Guest Post - The Sweet Smell of Preemption Overcomes Plaintiffs’ Stinky Consumer Fraud Claims

The ingenuity of our friends in the plaintiffs’ bar is never-ending and always fascinating, like Cyrano de Bergerac’s prodigious proboscis. For example, this post is about a case brought by some resourceful lawyers who did ...more

First Amarin Pharm v. FDA, Now Pacira Pharm, Inc. v. FDA

The Southern District of New York certainly is becoming a hotbed for issues relating to the FDA’s ability to take enforcement action against manufacturers who promote their FDA-regulated products for uses outside the approved...more

Legislative Action to Remove Microbeads from Personal Care Products Intensifies

The International Campaign Against Microbeads in Cosmetics is most likely celebrating this week, following the California State Legislature’s passage of a bill that would prohibit the use of plastic microbeads in personal...more

New DOJ Guidance Sharpens the Focus on Prosecuting and Suing Individuals in Corporate Criminal Investigations

On September 9, 2015, the U.S. Department of Justice (“DOJ” or the “Department”) issued a memorandum to its staff revising the principles guiding criminal and, indeed, civil enforcement in corporate criminal investigations...more

What’s in a Name? When You’re Selling a Food with an Established Federal Standard of Identity, a Whole Lot!

A bluntly labeled section of the Code of Federal Regulations – “Mayonnaise” – provides a description of this particular food dressing, the food’s required ingredients, optional ingredients, and how to declare those...more

Warning Letters and Jurisfiction

“Jurisfiction” is a word coined by Jasper Fforde, author of the Tuesday Next series, one of the more sophisticated set of children’s works that has come to populate this post-Harry Potter era. To be very brief, Jurisfiction...more

New Jersey Federal Baked Goods Fraud Class Actions Are Toast

On this date in 1901 (September 2nd), Teddy Roosevelt for the first time uttered in public the immortal phrase, "Speak softly and carry a big stick". It is hard to find people who do not admire that statement. It is harder...more

Advertising Law - August 2015 #4

In Case You Missed It: Possible Jail Time for TCPA Violations, Microsoft Gets Slammed With Solicitation Scam Class Action, and 'Do Not Disturb' Technology Gets Pushed on FCC - The world of the Telephone Consumer...more

Another Successful First Amendment Challenge to the Prohibition of Off-Label Promotion for FDA-Approved Drugs

The Free Speech Clause of the First Amendment prevailed in the latest challenge to the FDA's prohibition against marketing FDA-approved drugs for off-label (or non-FDA-approved) uses. Applying the Second Circuit’s...more

Ninth Circuit Addresses Preemption in Recent Labeling Cases

The Ninth Circuit Court of Appeals recently addressed preemption in the context of food and cosmetic labeling. Food Manufacturers Can Label Honey as “Honey” - In June, the Ninth Circuit issued an opinion in Brod v....more

Off-Label Marketing and the False Claims Act

In a post published earlier this week this week our colleagues Brian Dunphy and Joanne Hawana examined key issues in the recent Amarin decision from the Southern District Court of the New York. The August 7th ruling provided...more

PMA Medical Device Preemption Decision – Better Late Than Never

We recently learned of Thomas v. Alcon Laboratories, ___ F. Supp.3d ___, 2013 WL 10888983 (N.D. Ga. Jan. 29, 2013), dismissing a contact lens product liability complaint as preempted under Riegel v. Medtronic, Inc., 552 U.S....more

Animal supplements still in limbo, facing increased FDA scrutiny

The thousands of food, agriculture and life sciences companies regulated by the federal government already face a barrage of complicated regulations. Add in significant regulatory uncertainty and a major reorganization of the...more

Pharmaceutical Companies Get Off-Label Marketing Victory

Last week, a federal judge ruled that the Food and Drug Administration (FDA) cannot prohibit a pharmaceutical company from marketing its drugs for off-label uses if its claims are truthful and not misleading. This ruling,...more

How To Handle Homeopathy?

Search for “homeopathy” on the Internet, and one quickly discovers that this particular form of “alternative medicine,” does not have the greatest reputation. Wikipedia, not always an unimpeachable source, but usually OK for...more

District Court Holds That FDCA Does Not Prohibit and Criminalize Truthful Off-Label Promotion of FDA-Approved Prescription Drugs

On August 7, 2015, the U.S. District Court for the Southern District of New York released its Amarin opinion addressing whether truthful, non-misleading off-label promotion of U.S. Food and Drug Administration (FDA)-approved...more

OMG: Kim Kardashian Prompts FDA Warning Letter

Kim Kardashian recently trumpeted the beneficial effects of Diclegis, a pill indicated for the treatment of nausea and vomiting of pregnancy for certain women, to her over 42 million Instagram followers. One such Kardashian...more

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