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
In Omnicare, Inc. v. Laborers District Council Construction Industry Pension Fund, No. 13-435, the respondents fired back at the petitioners in a brief filed with the Supreme Court, posing a simple question:
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June, the U.S. Food and Drug Administration (the "FDA") announced that by the end of the year, the agency would issue a draft guidance document addressing the contours of lawful and unlawful off-label promotion.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
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
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
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
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
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
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
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
Two whistleblowers used the qui tam provisions of the False Claims Act (FCA) to file lawsuits against biotechnology company Genzyme Corp. for teaching doctors and other medical staff how to create a "slurry" version of its...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
In a recent decision issuing from the Central District of California, the court evaluated requirements pertaining to federal preemption and pleading, and granted Medtronic, Inc. and Medtronic Sofamor Danek, USA, Inc.’s...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
On May 17, 2013, the U.S. District Court for the Northern District of Georgia issued an order that joins an unsettling line of decisions suggesting that before filling prescriptions, pharmacies must serve as the arbiters of...more
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
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
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