Drugs

Actual Use Study Flagged in OTC Birth Control NDA

FDA reviewers are questioning the reliability of an actual use study that was submitted to support approval of a Laboratoire HRA Pharma NDA seeking a prescription-to-nonprescription switch of its Opill, a norgestrel tablet 0.075 mg oral contraceptive pill.

In a briefing document released in advance of a 5/9-10 advisory committee meeting, the reviewers said they found that a substantial portion of individuals in the actual use study over-reported the number of tablets they took. “The improbable dosing and the substantial proportion of subjects with improbable dosing, without identifiable root cause(s), call into question the reliability of all of the actual use data in ACCESS-UP — therefore not providing reliable information to assess an individual’s ability to appropriately use this product,” the reviewers wrote.

They said they were also concerned about data supporting “comprehension and deselection in females with a history of or current breast cancer” because hormonal contraception is contraindicated in females with a history of, or current, breast cancer. “Comprehension of this contraindication did not approach the prespecified target threshold in the LCS [label comprehension study], and there were participants who failed to correctly deselect in the targeted breast cancer and ACCESS self-selection studies," they wrote.

FDA’s briefing document says that the advisory committee members will be asked to discuss both concerns and other issues during the two-day panel meeting.

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