The United States Food and Drug Administration Off-Label Use

The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the... more +
The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the passage of the 1906 Pure Food and Drugs Act. The agency is charged with protecting the integrity of the nation's food supply and cosmetic products, as well as monitoring the safety and efficacy of drugs, medical devices, and biological products.  less -
News & Analysis as of

Is Off-Label Drug Promotion Protected Free Speech?

It is a very common practice. Drug sales reps visit a client, usually a hospital, a clinic or a doctor, with the sole purpose of selling a drug or medical device. That is the primary way a doctor learns about a drug or...more

FDA Promises Guidance on Lawful Off-Label Promotion

In June, the U.S. Food and Drug Administration (the "FDA") announced that by the end of the year, the agency would issue a draft guidance document addressing the contours of lawful and unlawful off-label promotion. The...more

Lawsuit Against Medtronic Alleges Racketeering Over Infuse Bone Graft

When one big industry sues another we learn a lot about how business as usual is conducted. In this case Humana, a giant health insurer, has sued the medical device company Medtronic, maker of the Infuse bone graft. ...more

Court enforces False Claims Act’s first-to-file rule to bar complaint alleging details of off-label promotion scheme about which...

In Brief - When an alleged scheme to market drugs for unapproved “off-label” uses had already been identified by an earlier complaint, a later complaint providing additional details, but alleging the same “essential...more

Putting Testosterone to the Test

Testosterone is the new big drug on the market. Marketed to men with ow T, a vague illness with even vaguer symptoms, there has been a recent explosion in its use. In line with this explosion are also the vast amounts of ways...more

False Claims Act Litigation Update: Bayer Decision Sheds Light on Pleading in False Claims Act Cases

A recent win for a large company in a False Claims Act suit (a seeming rarity as of late) alleging illegal off-label promotion could provide some helpful insight to similarly situated manufacturers and support dismissals of...more

Living off the Label

Doctors and physicians are given a great deal of discretion when it comes to prescribing drugs for uses other than those indicated by the FDA. This is known as “off-label” use. The FDA, realizing the danger of off-label...more

Unapproved New Uses: FDA Revisits Policies on Distributing Scientific Publications

In new Draft Guidance, FDA revises requirements for manufacturers’ distribution of publications about off-label uses for approved drugs or devices. On March 3, 2014, the Food and Drug Administration (FDA) released a...more

FDA Seeks Comments for Revised Draft Guidance Regarding the Distribution of Publications Discussing Off-Label Uses of...

The Food and Drug Administration (FDA) released a draft guidance that revises its 2009 guidance on Good Reprint Practices. The draft guidance reflects FDA’s current thoughts on this important topic that impacts drug and...more

FDA Updates Guidance Addressing Distribution of Scientific and Medical Publications on Unapproved New Uses

On February 28, 2014, the U.S. Food and Drug Administration (FDA) released a draft guidance entitled “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices.” The draft guidance,...more

New Reprint Guidance Maintains Bipartisan Status Quo

On February 28, 2014, the FDA issued its most recent unofficial guidance on distribution by manufacturers of research concerning off-label uses. With minor textual revisions, this new Guidance essentially restates the safe...more

Caronia And The First Amendment Defense To Off-Label Marketing: A Six Month Re-Assessment

When the Second Circuit issued its December 3, 2012 decision in United States v. Caronia, the opinion was proclaimed by many to signal a sea change in the prosecution of off-label promotion....more

Pro Te Solutio - Vol. 6 No. 1 February 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

Business Litigation Report -- April 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

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

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

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

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

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

Network Interference: A Legal Guide to the Commercial Risks and Rewards of the Social Media Phenomenon (2nd Edition)

In October 2009, we published the first edition of this White Paper, focusing primarily on social media issues in the United States. The response was overwhelming and far beyond our expectation — clients, friends, press and...more

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

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

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

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

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

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

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

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?

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

Court’s Ruling about Off-Label Drug Promotion Defies Reason

Last week a federal appeals court made a ruling that chips away at a fundamental aspect of the FDA's gatekeeping function with new drugs. The court tossed a conviction of a drug sales representative who was promoting drugs...more

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

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

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