FDA Policy/General

OPDP Says Chiasma Promoting IND

A Chiasma YouTube video is promoting the investigational new drug octreotide, including using its proprietary name Mycapssa, according to a 12/21 Notice of Violation issued by the CDER Office of Prescription Drug Promotion to the company. The OPDP letter cites a 4/18/16 Chiasma press release reporting on the agency’s complete response letter that said the company had not provided substantial evidence of efficacy to warrant approval and would need to conduct another clinical trial to overcome the deficiency.

“The video presents claims that promote octreotide capsules as safe and effective for the purpose for which it is being investigated or otherwise promotes the drug,” OPDP says. It cites claims that make “numerous positive and conclusory statements about the safety and effectiveness of octreotide capsules, such as suggesting that ‘the drug is safe’ and ‘the effectiveness of the drug was proven in the clinical trials.’” The letter says that the claims suggest in a promotional context that octreotide capsules are safe or effective for such uses, when FDA has not approved them for any use.

While the company superimposed a message in the video that the product is an investigational new drug and not available for commercial distribution, OPDP says that there is no disclaimer that would sufficiently mitigate the extensive claims and presentations throughout the majority of the video suggesting that the drug is safe and effective.

Chiasma was told to stop using violative promotional materials and to respond with a plan for discontinuing use of such materials.

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