Drugs

‘Concerning’ DTC Ad Misbrands Hizentra: FDA

A direct-to-consumer TV ad for CSL Behring’s Hizentra (immune globulin subcutaneous (human)) overstates the drug’s effectiveness and minimizes safety information, thus misbranding it, according to a CBER Warning Letter. The letter says the Hizentra labeling describes it as a 20% liquid subcutaneous immune globulin indicated to treat primary humoral immunodeficiency in adults and pediatric patients two years of age and older, and chronic inflammatory demyelinating polyneuropathy in adults, as a maintenance therapy or to prevent relapse of neuromuscular disability and impairment.

Hizentra has a Boxed Warning about the potential of thrombosis, CBER says, and also has Contraindications, Precautions, and Warnings.

The letter describes elements of the ad that CBER says overstate its effectiveness and minimize the safety information, and says they are concerning from a public health standpoint because the ad creates the misleading impression that Hizentra is more effective than has been demonstrated by substantial evidence and minimizes the risks of treatment with the product.

CSL Behring was told to respond with a list of all Hizentra promotions that contain representations such as those described in the letter and a plan to discontinue such communications or to cease distributing the drug. The company is also to submit a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective communications about the concerns discussed in the letter to the audiences that received the violative promotions.

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