Off-Label Use Pharmaceutical Industry

News & Analysis as of

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

FDA Files Brief Regarding Off-Label Promotion In Amarin Pharma Lawsuit

As we mentioned in our prior post, the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit pending in the Southern District of New York raises interesting issues regarding the First Amendment and how it...more

Drug Manufacturer Sues FDA Over Constitutional Right To Discuss Off-Label Uses

The FDA has long sought to ban drug manufacturers from promoting off-label uses for approved drugs. The ban – which applies only to manufacturers and their agents – is intended to safeguard the public against misbranded...more

Amarin Pharma Sues FDA Over Constitutional Right to Discuss Off-Label Uses

Drug makers and the Food and Drug Administration (FDA) have often disagreed over whether drug makers can discuss unapproved uses for their products with physicians. While courts have sided with drug makers in certain...more

Maryland, My Maryland: Aldara Case Dismissed for Multiple Reasons

Today’s date is rich in literary history. It is the birthday of Vladimir Nabokov, one of two writers whose prose style makes us want to snap our Pilot Varsity pens in despair, so great is the gap between those authors'...more

Notes From The Off-Label Underground

Keeping track of litigation over off-label use/promotion frequently sends us off on tangents. We’ve wandered into abortion cases, securities law cases, criminal cases – even cases brought by criminals....more

Free Speech & Pharmaceutical Promotion — U.S. ex rel. Solis v. Millennium Pharmaceuticals, Inc.

Off-label prescription drug use — using drugs to treat ailments not indicated on FDA-approved labeling — is among the thorniest legal issues facing the pharmaceutical sector. On one hand, off-label prescriptions are lawful...more

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

GlaxoSmithKline Fined Again – The Cost of Doing Business?

It is seen as the cost of doing business. It may be illegal, but is also highly profitable, so why stop? That seems to be the attitude of many pharmaceutical companies – and the latest proof of that comes in the form...more

Supreme Court Declines to Opine on Circuit Split Over Rule 9(b) Pleading Requirements for FCA Claims

On March 31, 2014, in U.S. ex rel. Nathan v. Takeda Pharmaceuticals North America, the Supreme Court of the United States declined to review a decision by the U.S. Court of Appeals for the Fourth Circuit upholding a district...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

Federal Court Invalidates 340b Orphan Drug Regulation

Last Friday a federal district court invalidated a regulation that had authorized the 340B discount for critical access hospitals, sole community hospitals, rural referral centers and free-standing cancer hospitals when they...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

First Circuit Rules on Scope of FCA First-to-File Rule in U.S. v. Bristol Myers Squibb, Inc.

The First Circuit ruled last week that an earlier-filed False Claims Act complaint will preclude a later-filed complaint if it arises out of the same underlying facts, even if the allegations are not identical. The...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 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

False Claim Act: 2013 Year in Review

Last year continued the trend of robust False Claims Act (FCA) enforcement by the U.S. Department of Justice (DOJ) and proliferating qui tam lawsuits brought by whistleblowers on behalf of the United States. In 2012, DOJ...more

J&J Will Pay $2.2 Billion and Enter 5-Year CIA to Settle Off-Label and Kickback Charges

This week, the DOJ announced that J&J has agreed to pay over $2.2 billion in civil and criminal fines in one of the nation’s largest ever health care fraud settlements. As part of the resolution, J&J subsidiary Jannsen will...more

’Orphan drug’ rule raises off-label worries for drugmakers

The U.S. Department of Health and Human Services last week clarified when hospitals are allowed to buy socalled orphan drugs at sharply discounted prices, but it left open questions for drug manufacturers about the risk of...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

Appeals Court Rejects Drug Company Executive’s First Amendment Defense and Upholds Wire Fraud Conviction

A three-judge panel of the U.S. Court of Appeals for the Ninth Circuit, in a recent unpublished opinion, upheld the conviction and sentencing of former InterMune, Inc. executive Scott Harkonen for wire fraud. In 2009, a jury...more

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