Drugs

FDA Denies Oral Contraceptive Switch Petition

FDA has denied a 9/22/14 petition submitted by attorney, pharmacist, and former FDAer Larry Pilot asking that it switch oral contraceptive products from prescription-only to over-the-counter purchasing status. The petition said that such a switch was appropriate in light of “user awareness … coupled with product refinements over time [that] have established that these oral contraceptives, when used as instructed in accordance with approved labeling, are safe and effective for informed purchase and use by women.” Pilot also cited the nonprescription availability of oral contraceptives in other countries and the cost saving that could follow the switch.

The FDA denial letter notes that the agency evaluates marketing applications for drug products for OTC use on a case-by-case basis and sponsors interested in exploring development of nonprescription oral contraceptives can meet with agency staff to discuss development of the data necessary to support such an application.

“In order to initiate a classwide switch of the type requested by your petition,” the letter says, “sufficient data would need to be before the agency to support the safe and effective OTC use of these products. Your petition, however, does not present such data. Moreover, the arguments in your petition are insufficient to persuade FDA to initiate rulemaking for a classwide switch of oral contraceptives at this time.”

The agency says that marketing applications or rulemaking to switch oral contraceptives to nonprescription use would likely need to be supported by results from adequately designed consumer studies that address the adequacy of OTC labeling, and whether consumers can adequately self-select and safely and effectively use the products being proposed.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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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