Drugs

Court Helps Define Off-label Promotion

A Texas federal court decision helped define off-label promotion by giving two examples of activities that don’t count as promotion. Attorney Elizabeth Minerd (Reed Smith) writes in a Drug and Device Law blog post that while in recent years there have been numerous cases discussing the legal ramifications of promoting drugs or medical devices for off-label uses from many angles, the basic question of what constitutes off-label promotion has gone largely unanswered.

In United States ex rel. King v Solvay, she writes, whistleblowers claimed False Claims Act violations because it was “off-label promotion” for the company to (1) send dossiers of information to third-party payer formulary committees that included off-label information and (2) distribute a supplement of the American Journal of Managed Care reporting proceedings at a symposium where off-label information was discussed.

The court found that the dossiers of information were sent in response to the formulary committees’ request for “all available clinical data” for the drug. The court agreed with Solvay that the dossiers consisted of information that was compiled by doing literature searches and providing references that were not promotional in nature.

The company also argued that there was no evidence that it, rather than the journal publisher, distributed the journal supplement and said that its sales representatives had been cautioned not to use the supplement in any promotional manner. The court accepted that it was not known who distributed the supplement and that the sales reps had been put on notice that it could not be used to promote the drug.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome