The Era of Generic Biologic Drugs Has Officially Begun: An Update on U.S. Biosimilars
IS THE A IN ANDA BEGINNING TO MEAN ANTITRUST?
FCPA Compliance and Ethics Report-Episode 82, continued fallout from GSK in China
Biosimilars in the U.S. and Abroad
Innovative Exit Strategies for Life Sciences Companies – Interview with Bill Whelan, Member, Mintz Levin
The Sunshine Act: Putting It into Practice – Interview with Karen Lovitch, Member, Mintz Levin
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
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
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
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June, the U.S. Food and Drug Administration (the "FDA") announced that by the end of the year, the agency would issue a draft guidance document addressing the contours of lawful and unlawful off-label promotion.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
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
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
- 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
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
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
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.
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
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
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
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
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
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
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
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
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
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
On March 4, 2013, a panel of the United States Court of Appeals for the Ninth Circuit issued its opinion in United States v. Harkonen,1 a case in which the CEO of a pharmaceutical company was prosecuted for transmitting...more
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
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
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
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
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