Drugs

New Approach Needed on Off-label Promotion: Attorney

Attorney Jeffrey Shapiro (Hyman, Phelps & McNamara) says that the current legal/enforcement situation regarding off-label promotion of drugs and medical devices has little to commend it. Writing in an online Update, Shapiro says that the status quo “does not respect the First Amendment rights of device and drug makers or physicians. It arbitrarily and capriciously exposes selected manufacturers and their executives to significant legal jeopardy for conduct that is not per se unlawful. And most importantly, it does not provide real protection to patients, who indisputably benefit from many off-label uses.”

Shapiro suggests that it may be time for FDA and the Department of Justice (DoJ) to declare an immediate moratorium on its enforcement actions in this area while they develop an approach that does not infringe First Amendment rights. “There would still remain the requirement that device and drug manufacturers label and advertise their products in a manner that is not false or misleading,” he writes. “The courts have expressly acknowledged that this type of enforcement does not infringe First Amendment rights.”

The agency should consider, the article says, how important it is that FDA conduct premarket review of every single use for a device or drug. “Should steps be taken to incentivize manufacturers to undertake premarket review of new uses,” Shapiro asks. “Or is it sufficient to primarily rely, as is generally done now, upon physicians and researchers to ensure the safety and effectiveness of uses not reviewed by FDA? There is a lot of work to be done in sorting out these and other related issues, but it cannot fairly begin until FDA and the DoJ let go of the current system.”

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