FDA says it is continuing to advance its scientific and technical capabilities, but a recent New York Times editorial says the agency is in trouble, with “too few resources and too little power to fulfill its key responsibilities.” The editorial adds that FDA “has also become profoundly vulnerable to political interference and other special interests. And a revolving door — FDA staffers frequently go on to lucrative jobs at the very companies they were tasked with policing — has hurt the agency’s credibility.”

But in a recent brief, Amy Abernethy says, “Critical steps in transforming our computing and technology infrastructure are reflected in the FDA’s Technology Modernization Action Plan. This plan is an important step in closing the gap between scientific advances and the computing solutions needed to translate those advances into new therapies for patients.” Abernethy, MD, PhD, is FDA principal deputy commissioner.

FDA is holding a public meeting on March 27, 2020, at FDA’s White Oak campus to discuss possible agency-level approaches to modernizing the FDA’s data strategy, including approaches to data quality, data stewardship, data exchange and data analytics.

“Data are the foundation of our most important work as a science-based regulatory agency — from reviewing medical products to identifying the source of a food-borne illness outbreak,” says FDA Commissioner Stephen M. Hahn, MD.

“Because data are so essential to what we do, we are committed to ensuring that our mechanisms for collecting, reviewing and analyzing data are equally as sophisticated as the scientific advances that we are reviewing,” he says.

The meeting is one more step in FDA’s efforts to modernize technology used at the agency, as detailed in its Technology Modernization Action Plan (TMAP), released in September 2019. The TMAP describes steps FDA is taking to modernize the use of technology, including computer hardware, software, cloud-based solutions and data exchange.

But are these kinds of efforts enough? According to the Times, no. It calls for more drastic and overarching changes that would change how the agency operates, including:

  • Implementing laws that would make it easier for regulators to police the cosmetics industry and to hold medical device companies more accountable. Such laws have been floating through Congress for years.

  • Restoring the agency’s autonomy by extracting it from the Department of Health and Human Services — an idea put forth by a group of former FDA commissioners last year. This would entail removing the layers of political interference. “Making the agency independent, as the Federal Reserve and the Social Security Administration are, could help reverse that trend,” says the Times.

Sherrie Trigg

Editor and Director of Medical Content

To read the New York Times article, go here .


Medical Design Briefs Magazine

This article first appeared in the February, 2020 issue of Medical Design Briefs Magazine.

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