Drugs

Comments on Breakthrough Therapy Recission Draft

Pharmaceutical Research and Manufacturers of America (PhRMA) is calling on FDA to identify the legal authority for rescinding breakthrough therapy designations (BTDs) as described in a draft guidance. Its comment letter also says the agency should (1) explicitly incorporate procedural details from relevant SOPPs (standard operating policies and procedures) and MAPPs (Manual of Policies and Procedures), and (2) clarify the examples on when it may, or may not, rescind a BTD.

Gilead says it supports FDA’s thinking on partnering with sponsors and clinical trial design, endpoint, and other evaluative data flexibility under BTDs based on new data that may arise during the clinical trial process. It asks that the agency further consider integrating any final version of the draft guidance with an existing guidance on expedited programs for serious conditions, include the process for sponsors to respond to an FDA request to rescind a BTD, and add an acknowledgment that sponsors may request that a BTD be rescinded.

The Cystic Fibrosis Foundation says it believes that an FDA policy of rescinding BTDs under an alternative drug provision “undermines the legitimate benefits of rapidly bringing multiple drug products for underserved conditions to market.” It says the agency should explicitly take varying patient response profiles and serious adverse events into account when determining whether to continue BTD in these situations.

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