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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
..Are threats made on social media protected free speech, or potentially criminal acts? The U.S. Supreme Court has agreed to examine the constitutionality of a federal law making it a crime to transmit communications...more
The U.S. Food and Drug Administration (FDA or the Agency) issued the June 6, 2014, draft guidance (Draft Guidance) in response to stakeholder inquiries into the Agency’s views on disseminating new scientific or medical...more
On June 6, 2014, the Food and Drug Administration (“FDA”) issued two documents that reflect the agency’s ongoing effort to clarify its regulatory approach regarding manufacturer communication of scientific and medical...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
On November 27, 2013, the Drug Quality and Security Act was signed into law. This new law provides clarity to the existing pharmacy compounding laws within Section 503A of the Food, Drug & Cosmetic Act (FDCA) and creates new...more
Truthful, non-misleading off-label promotion of prescription drugs is not illegal. At least, not in the Second Circuit. This, despite the billions of dollars in civil and criminal penalties assessed against pharmaceutical...more
On March 7, 2013, the United States Food and Drug Administration (FDA) issued a warning letter to compounding pharmacy Medi-Fare Drug & Home Health Center (Medi-Fare Drug), taking the FDA's most aggressive position to date...more
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
On December 3, 2012, the United States Court of Appeals for the Second Circuit overturned the conviction of a pharmaceutical sales representative convicted for misbranding in violation of the federal Food, Drug and Cosmetic...more
On December 3, 2012, the United States Court of Appeals for the Second Circuit issued a landmark decision in United States v. Caronia, holding that “the government cannot prosecute pharmaceutical manufacturers and their...more
Last year, the Supreme Court limited the ability of states to regulate the sale of prescription data. In Sorrell v. IMS Health, the Supreme Court determined that a 2007 Vermont law that effectively banned the...more
While we’re all waiting for the Second Circuit to decide the Caronia case – and, we hope, hold that the FDA’s prohibiting the truthful promotion of off-label use violates the First Amendment – we’d like to pass along some...more
On June 23, the U.S. Supreme Court issued a 6-3 decision in Sorrell v. IMS Health Inc., declaring a Vermont law designed to prevent data mining unconstitutional. The Vermont Prescription Confidentiality Law at issue...more
On June 23, 2011, the United States Supreme Court struck down Vermont’s law restricting the sale, disclosure, and use of pharmacy records that reveal the prescribing patterns of individual physicians. Vermont and other states...more
On Thursday, the Supreme Court issued its decision in Sorrell v. IMS Health Inc., a case testing the constitutional limits of governmental restrictions on the speech of pharmaceutical manufacturers. By a vote of 6-3, the...more
The United States Supreme Court issued its decision in Sorrell v. IMS Health, Inc., et al. on June 23, 2011. The 6-3 decision, authored by Justice Anthony Kennedy, struck down the Vermont Prescription Confidentiality Law (Vt....more
Generic Manufacturers Win Preemption In Mensing
The Court decided 5-4 in favor of generic preemption today in Pliva, Inc. v. Mensing, No. 09–993, slip op. (U.S. June 23, 2011). We’d like to talk about Mensing, but it’s a...more
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