> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# ‘Missed Opportunity’ on FDA Reforms: Ex-Commissioners
- URL: https://www.fdaweb.com/missed-opportunity-on-fda-reforms-ex-commissioners/
- Published: 2022-10-14T12:00:00.000Z
- Updated: 2026-09-14T18:03:18.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5152978

The recent user fee reauthorization was a “profound missed opportunity” to reform FDA regulatory approaches on diagnostic devices, dietary supplements and cosmetics, according to former FDA commissioners **Mark McClellan** and **Scott Gottlieb**. Writing in an online [*JAMA Forum*](https://jamanetwork.com/journals/jama-health-forum/fullarticle/2797520?ref=fdaweb.com) 10/13, they say lawmakers missed a “once-in-a-generation” chance to make meaningful reforms that were developed through a largely bipartisan process.

“All three industries are benefiting from technological advances that offer new opportunities to improve people’s health, but also create new uncertainties and risks,” they write. “For each of these industries, evidence indicates that products that slipped through a porous regulatory framework have [put](https://www.nejm.org/doi/full/10.1056/nejmsa1504267?ref=fdaweb.com) some [individuals](https://www.cdph.ca.gov/Programs/CCDPHP/DEODC/OHB/CSCP/CDPH%20Document%20Library/DataReport.pdf?ref=fdaweb.com) at [risk](https://www.fda.gov/medical-devices/in-vitro-diagnostics/laboratory-developed-tests?ref=fdaweb.com). Industry participants have also expressed concerns about difficulties in advancing potentially beneficial new kinds of innovations under the FDA’s existing regulatory authorities, which have not kept up with the market’s current state.”

The former chiefs note that Congress could authorize the measures In December when a longer term spending bill is expected to pass, “(b)ut that prospect is slim unless there is a strong bipartisan commitment to enact them.”

Especially, McClellan and Gottlieb see the need to overhaul the regulation/oversight of diagnostic tests. “Today’s diagnostic tests using genetic and other markers are evolving rapidly, as more sophisticated markers and richer data become available,” they say. “But the FDA does not allow diagnostic tests already under its active oversight to be adapted quickly as the predictive value of genetic and other markers for disease risk evolves. The result is a cumbersome process for manufacturers of diagnostic tests to update their products based on the latest evidence and detection capabilities.”

They say in contrast, laboratory-developed tests are mainly excluded from FDA’s regulatory framework and their makers can introduce new tests or modify existing tests without the agency’s permission. “This approach allows laboratory-developed tests to be updated rapidly, but does not provide a reliable assurance of consistent quality,” they note.

The recent proposed FDA legislation that was attached at one time to the user fee reauthorization “creates a modern framework uniquely tailored to diagnostic tests and the rigor taken by the entities that develop them, including a new pathway to allow the FDA to take a laboratory- or company-based approach to regulation,” McClellan and Gottlieb write. “The FDA would oversee the process used to develop and validate tests, rather than regulating only the tests themselves. Laboratories with good procedures for ensuring the reliability of their tests would, in many cases, be able to market new tests and iterations of existing platforms without undergoing the same premarket adjudications. At the same time, the new pathway would give the FDA clear authority to oversee tests and ensure that all tests meet certain common requirements for demonstrating that they reliably produce the molecular and genomic findings that they are intended to generate.”

In conclusion, McClellan and Gottlieb say the small issues that remain to advance these reforms could be worked out through the congressional committees that oversee FDA. “Congress should seize this opportunity to achieve long-awaited reforms that will modernize FDA’s regulation, promote innovation, and provide US consumers greater assurance that the products they use are safe and reliable,” they say.