FDA Policy/General

FDA Gets Consent Decree Against Supplement Marketer

Viruxo, a Florida dietary supplement distributor, has been ordered by a federal court to stop selling its product, which it claimed could treat herpes. The order came in a consent decree of permanent injunction between FDA and James R. Hill, doing business as Viruxo LLC. The complaint also included a civil fraud charge for Hill’s intent to defraud consumers by promoting his product to cure, mitigate, treat, or prevent a disease “despite the absence of well-controlled clinical studies or any other credible scientific evidence to substantiate his claims,” an agency release says.

In 2011, FDA and the FTC sent Hill a Warning Letter for making therapeutic claims on his Web site establishing that the product was a drug because it was intended for use in the cure, mitigation, treatment, or prevention of disease. The letter also stated that Hill’s product was a misbranded drug because its labeling failed to provide adequate directions for use. “Despite assurances that Hill was correcting violations noted in the Warning Letter, he continued to market his product on the Internet to consumers as a treatment for herpes,” the agency said.

The consent decree prohibits Hill from marketing misbranded or unapproved new drugs. Before he can resume operations, he must, among other things, hire a labeling expert, remove all representations from his Web site and other promotional materials that his product can cure, mitigate, treat, or prevent disease, and receive written permission from FDA to resume operations. In addition, it requires Hill to notify the FDA at least 14 days before the creation of a new Web site.

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