Drugs

Panel Unanimously Backs OTC Contraceptive Pill

Advisory committee members 5/10 voted 17 to 0 to recommend the 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.

Overwhelmingly, panel members dismissed FDA concerns outlined in a briefing document released in advance of the two-day advisory committee meeting (see earlier story). Agency reviewers had 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,” they 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.

In voting yes to recommend the Rx-to-OTC switch, Johns Hopkins Professor of Gynecology and Obstetrics Deborah K. Armstrong said the risk of unintended pregnancy is lower with this approach than any of the other available contraceptive approaches that are available to women without seeing a health care provider. She also said that the proposed contraindications for use will be well understood by women selecting the product.

Centers for Disease Control and Prevention health scientist Kathryn Curtis agreed that the evidence demonstrates that the benefits clearly exceed the risks. “The benefits of moving a pill over the counter include increased access to contraception, especially those who face multiple barriers that we heard about yesterday [from the open public comment period], reduction and unintended pregnancy and associated risks, and improved reproductive autonomy and improved equitable access to contraception, which we also heard about so passionately yesterday. So, for all of these reasons, I think Opill has the potential to have a huge positive public health impact.”

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

Read more

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