The last couple of times we’ve commented on new law review articles, we haven’t liked what we’ve seen very much. We’re gluttons for punishment, however, and this time we were rewarded. We found a couple of recent law review...more
Officers and directors of Irish and Northern Irish companies whose products would be regulated by the US Food and Drug Administration (life sciences companies, specifically) should be aware of developments on the issue of...more
Two stories in 360 yesterday – the timing was pure coincidence – have us thinking again about the FDA’s muddled and increasingly untenable position on truthful off-label “promotion” – broadly defined as any accurate...more
Finding that a drug label’s language did not rise to the level of “active encouragement” that would induce doctors to infringe, the U.S. Court of Appeals for the Federal Circuit upheld the district court’s denial of a...more
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
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
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
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
Third party payors (“TPPs”) responsible for paying the costs of prescriptions for their beneficiaries sued Cephalon, Inc., alleging that it engaged in unlawful off-label marketing of Actiq, a drug approved to manage...more
In Thorn v. Medtronic Sofamor Danek, USA, the Honorable Janet T. Neff dismissed the plaintiff's state law claims of failure to warn and negligence as preempted under the Medical Device Amendments of 1976 ("MDA"), 28 U.S.C. §...more
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
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
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
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