Drugs

Advisors on Makena Must be ‘Fairly Balanced’: Public Citizen

Public Citizen says the FDA Bone, Reproductive, and Urologic Drugs Advisory Committee that will consider whether Covis Pharma’s Makena (hydroxyprogesterone), indicated to reduce the risk of pre-term birth, should be withdrawn from the market must be fairly balanced to ensure hearing process integrity. In a statement (contains a link to a 10/27 letter to FDA), the consumer advocacy group calls on the agency to reject a Covis proposal “to essentially stack the jury in its favor by significantly expanding the advisory committee roster for the hearing with individuals whom the company believes will be sympathetic to its view that Makena should remain on the market.”

Public Citizen petitioned the agency 10/2019 to take Makena and related generic products off the market because a large FDA-mandated post-approval clinical trial ordered as part of an accelerated approval, showed the drug is not effective.

Public Citizen says the panel should be fairly balanced in terms of the points of view represented; constituted in a manner to ensure independent judgment; and the members must have both relevant expertise and diverse professional education, training, and experience.

In its letter, Public Citizen backed a CDER position that the composition of the committee should include multiple members with expertise in biostatistics and members with expertise in epidemiology, neonatology, understanding real-world evidence, and the regulation of pharmaceuticals. The group also recommended that no more than one-third of the voting committee members be practicing obstetricians.

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