5:53 PM
Sep 14, 2018
 |  BioCentury  |  Politics, Policy & Law

Debating diagnostics

Debate over diagnostics regulation in Washington suggests agreement could be in sight

Instead of perpetuating a decades-old dispute about whether FDA can and should regulate laboratory-derived tests, the agency and test makers have moved on to conversations about how FDA should do so, and from threats of litigation to lobbying. This shift represents progress, and is a sign that there is hope for agreement on a scheme to replace a regulatory framework that was created before anyone had even conceived of technologies that are routine today.

Central to the debate are differing opinions about how best to promote innovation of technologies that are at the heart of personalized medicine while safeguarding the interests of patients.

The agency presented its ideas about overhauling diagnostics regulation in “technical assistance” provided to Congress in August in response to a discussion draft of the Diagnostic Accuracy and Innovation Act (DAIA) (see “A New Diagnosis”).

It proposed an approach to align regulation with scientific advances that is consistent with its treatment of regenerative medicine and digital health over the last year and a half: The agency would deploy regulatory resources to tests with the highest risks, shift regulatory focus from premarket to postmarket oversight, and create systems for voluntary precertification of technologies and quality systems. The agency also would integrate external expertise into regulatory decisions and increase scientific and medical transparency.

“Any approach that reallocates FDA’s premarket review resources must also include robust postmarket authorities.”

Scott Gottlieb, FDA

FDA is trying to persuade Congress to avoid prescriptive language in DAIA, arguing that data requirements or timelines that might make sense today are likely to become outdated, preventing the agency from responding effectively to new diagnostics technologies.

Academic and large commercial laboratories that...

Read the full 1368 word article

User Sign in

Trial Subscription

Get a 4-week free trial subscription to BioCentury

Article Purchase

$150 USD
More Info >