Drugs

Appeals Court Rules Against Homeopathic Drug Marketer

The DC Circuit Court of Appeals has affirmed a lower court decision recognizing FDA’s authority to place homeopathic drugs on its import alert listing after determining the products were unapproved drugs. In Medinatura v. FDA, homeopathic product marketer MediNatura challenged the agency’s withdrawal of Compliance Policy Guide 7132.15, Section 400.400, which established conditions under which homeopathic drugs could “ordinarily” be marketed without FDA’s premarket approval, so long as they complied with statutory and regulatory requirements for labeling, manufacturing, and registration. The lawsuit also challenged an import alert that impacted injectable drugs that the company imports from Germany.

The lower court’s opinion found FDA’s withdrawal of CPG 400.400 constituted a final agency action and is “ripe for judicial review” because it “removed the set of regulatory conditions under which unapproved homeopathic drugs were marketed for three decades.” Additionally, the court agreed with FDA’s argument that the import alert was not a final agency action because it “does not represent the culmination of the agency’s decision-making process.” It also agreed with FDA that the import alert was non-binding and therefore did not determine legal rights or obligations. Thus the import alert was found not ripe for judicial review.

On appeal, the high court affirmed the district court’s opinion.

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