FDA Policy/General

Proposed Deceptive Ad Studies Have Little Practical Use: PhRMA

Pharmaceutical Research and Manufacturers of America (PhRMA) says two proposed FDA studies on consumer and healthcare professional identification of false or misleading drug promotion appear to offer little practical usefulness. The association’s comment letter says that identifying deceptive promotion is FDA’s assigned responsibility and not the duty of consumers or healthcare professionals. It also says that deceptive drug promotion is not a prevalent problem that requires further studying.

“Given the agency’s regulatory requirements and current infrastructure to review promotional materials, direct-to-consumer pharmaceutical advertising is one of the most restrained and balanced forms of consumer advertising,” PhRMA says. “Research demonstrates that prescription drug promotion is overwhelmingly not deceptive, especially on Web sites and other online media.”

PhRMA also questions FDA’s assertion that one of the potential utilities of the studies is creation of a program for consumers to report deceptive prescription drug promotion to the agency since such a program already exists.

If FDA decides to proceed with the research, the letter says, PhRMA recommends consideration of several study design issues, including design of study stimuli, subject enrollment, and certain features of the study questionnaires.

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’

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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

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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