FDA Policy/General

FDA Rejects Petition Deadline

FDA has denied a 10/4/16 petition submitted by an individual identifying himself as Mario Morais asking that the agency amend an administrative procedure to require that it file a final response to every citizen petition within a certain number of days after issuing a tentative response. The denial letter says it appears that the petitioner believes that the procedure in question requires the agency to file a final, substantive response to every petition within 180 days.

“We read that provision to apply to FDA’s filing of one of three possible responses within 180 days, including not only a final approval or denial of the petition, but also a tentative response,” the letter says. It notes that responding finally and in full takes a great deal of both time and money, even when a petition is not likely to succeed on the merits or when it contains matters that are not a high priority.

The letter says the procedure intentionally gives FDA the option of providing only a tentative response once it has looked at the petition and taken into consideration available resources, the priority of the work, and any statutorily mandated timelines.

As it currently stands, FDA says, the procedure “permits FDA to target its limited resources toward work deemed a higher priority, and yet also satisfy an individual that the agency has heard and considered his or her concern… We find that the absence of a mandatory deadline for the agency’s final substantive response to a citizen petition is both intentional and reasonable.”

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