Drugs

Wide Variance in FDA Subpart H Approvals: Attorneys

Attorneys Frank Sasinowski and Alexander Varond (Hyman, Phelps & McNamara) say that their analysis of the strength of scientific and clinical evidence for FDA’s 19 non-AIDS, non-cancer Subpart H approval determinations over the accelerated approval program’s 24 years shows that the agency “exercises extraordinary regulatory flexibility in its Subpart H approvals.” Writing in the Food and Drug Law Journal, the two say that the agency exercises much more flexibility than is expressly provided for in the Federal Food, Drug, and Cosmetic Act, agency regulations, or its 2014 guidance on expedited programs for serious conditions.

The two researched the bases for FDA determinations when an unvalidated surrogate or intermediate clinical endpoint is “reasonably likely to predict clinical benefit.” For the 19 precedents, they say, they found wide variances between the quantum and quality of evidence on each of the three key factors outlined in FDA’s expedited programs guidance — (1) understanding of the disease; (2) understanding of the relationship between the drug effect and the disease process; and (3) clinical evidence for the unvalidated surrogate and the clinical benefit.

A company blog post on the report says the “critical takeaway from the paper is that a robust showing on the key factors in FDA’s May 2014 guidance is not required, or, as the authors write, ‘you don’t need to knock it out of the park’ on all three factors.” The two attorneys say they hope to promote a better understanding of the circumstances under which Subpart H may be employed to facilitate the development and expedited review of new drugs with the potential to address unmet medical needs for serious and life-threatening illnesses and to mobilize expanded FDA use of Subpart H.

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