Drugs

Agency Execs Defend Expedited Pathways

Two FDA Center directors are speaking out to defend the agency’s use of expedited approval pathways. In an FDA Voices online post, CDER director Janet Woodcock and CBER director Peter Marks say the pathways “deliver promising new medicines without sacrificing safety and efficiency. FDA walks a fine line. We must balance timely patient access to important new medicines with assuring they meet key standards. These standards exist to make sure that approved drugs have a high chance of helping those who use them.”

Woodcock and Marks write that while FDA applies the same statutory standards for safety and efficacy to all new medicines, the overall benefit-risk evaluation, and the clinical trial programs, vary depending on the circumstances.

Over the past three decades, they write, Congress has established five programs aimed at expediting patient access to important drugs that treat serious or life-threatening conditions. Such programs allow FDA to facilitate and expedite development of medicines that fill unmet medical needs while maintaining the agency’s gold standard of safety and efficacy. Products may sometimes qualify for more than one program, the post notes.

The post details the substantial differences among the programs and notes that from 2011 through 2018, of the 367 novel drugs that CDER and CBER approved, 200 (54%) used at least one expedited development tool.

Commentators have noted FDA’s increasing use of these programs over the last decade,” Woodcock and Marks write, “often with a view that the increase is driven by a loosening of our approval standards. In reality, FDA’s standards have not changed. Instead, the increased use of expedited approval pathways is directly related to the increasing numbers and scope of these programs provided by Congress, as well as the kinds of medicines that are being developed, and the types of diseases that are being studied.”

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

Read more

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