Drugs

FDA Prodded to Improve Surrogate Endpoint Transparency

A Federation of American Scientists (FAS) online paper calls for an interagency approach to increase transparency in validating surrogate endpoints used in FDA drug approvals. While FDA regularly updates its Table of Surrogate Endpoints That Were the Basis of Drug Approval or Licensure, FAS says, the table does not include information about the strength of evidence for each surrogate marker and its association with a clinical outcome.

“As surrogate markers are increasingly being accepted by FDA to support approval of new drugs and biologics,” the paper says, “it is imperative that patients and clinicians understand whether such novel endpoints are reflective of meaningful clinical benefits. Thus, FDA, in collaboration with other agencies, should take steps to increase transparency regarding the strength of evidence for surrogate endpoints used to support product approvals, routinely reassess the evidence behind such endpoints to continue justifying their use in regulatory decision-making, and sunset those that fail to show association with meaningful clinical outcomes.”

FAS recommends a three-step plan of action:

FDA should make more transparent the strength of evidence of surrogate markers included within the “Adult Surrogate Endpoint Table” and the “Pediatric Surrogate Endpoint Table”;
In collaboration with FDA, other federal research agencies should contribute evidence generation to determine whether surrogate markers are appropriate for use in regulatory decision-making, including approval of new therapeutic products and indications for use; and
Congress should build upon the provisions related to surrogate markers that passed as part of the 21st Century Cures Act of 2016 in their “Cures 2.0” efforts.

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