Nature Editorial: FDA Needs Help Assessing Cutting-Edge Tech

Posted 07 August 2017

placeholder+image

The US Food and Drug Administration (FDA) is increasingly being tasked with evaluating cutting-edge therapies and technology that its in-house expertise may not be able to address, according to a Nature editorial, which recommends academic scientists help the agency.

Using the example of the 12 July meeting of the Oncologic Drugs Advisory Committee that voted unanimously in favor of the benefit-risk profile for the first of a new kind of cancer therapy, the editorial notes that much of the meeting discussed the manufacturing of the new therapy, noting that it "offers a glimpse of the regulatory complexity that cutting-edge therapies present."

FDA "needs academic scientists to get involved," the editorial adds, offering ways for them to do so via the agency’s centers of excellence and collaborations with academic institutions.

"The Academics have traditionally shown little taste for the dry details of drug development. Many have fallen prey to the misconception that the FDA is not engaging with the latest science. The agency realizes that it has an image problem and, to its credit, is trying to change," the editorial says.

In addition, the editorial notes FDA’s "legendary struggle to retain its employees," particularly for "key positions such as those of bioinformaticians, where supply falls well short of demand," and as competition with industry for skilled job candidates is "particularly intense." 

Measures like FDA commissioner Scott Gottlieb’s pilot project to speed FDA’s recruitment process could help, the editorial adds. But FDA "will need more than that to remain effective in the face of future challenges. As the agency delves into new science, a continuing dearth of expertise will become only more painful."

Editorial

Share this article:

Categories: Biologics and biotechnology, Drugs, Government affairs, Regulatory strategy, Regulatory intelligence, News, US, FDA

Tags: CAR-T, academic scientists, Scott Gottlieb

Regulatory Exchange: Latest Updates From the Community