Dive Brief:

• Scott Gottlieb, the Trump administration's former FDA commissioner, took to Twitter on Saturday strongly criticizing the decision of former colleagues that FDA will no longer require premarket review for laboratory developed tests. In a series of tweets, Gottlieb railed against the new HHS policy which applies to all LDTs, not just COVID-19 diagnostics, and reverses a "long established" public health precedent.  
• Gottlieb warned that FDA’s ability to protect public health could be hindered by the new policy. "FDA might not be able to provide critical advice to test developers or take needed enforcement actions against bad tests. After all, how can FDA take action over something HHS says it doesn't regulate?" Gottlieb wrote. 
• While the new policy goes beyond COVID-19 and applies to all LDTs, Gottlieb argued that policies issued in the middle of a pandemic should be carefully considered for their impact. He warned that as a result of the administration's decision a "plethora" of direct-to-consumer coronavirus tests will now enter the market and be "processed in a central lab operating outside FDA oversight."

Dive Insight:

When HHS announced its decision late Wednesday on LDTs, the department said the policy change was made as part of its ongoing review of "regulatory flexibilities" put into place since January's public health emergency declaration. While labs can voluntarily seek approval, clearance or emergency use authorization for an LDT, they are no longer required to do so.

Gottlieb, who led the agency from May 2017 until April 2019, argues the HHS decision will have potentially dire consequences for the nation's response to the coronavirus.  

"For the last 6 months, FDA’s device center worked effectively with labs to advance hundreds of tests for COVID. A new HHS policy that extricates FDA from this work - and goes further, by removing any FDA role over any lab developed test - could put this work at risk," wrote Gottlieb, who has become a fixture on TV news shows throughout the pandemic and leveraged his widely-followed Twitter account to weigh in on policies.

"FDA has worked with labs to advance countless testing innovations under FDA’s Emergency Use Authorization (EUA) authority," Gottlieb added. "Under this process FDA provides feedback to test makers. Countless labs say FDA counsel helped improve test quality. The process was efficient; FDA’s staff is highly responsive."

THREAD: For the last 6 months, FDA’s device center worked effectively with labs to advance hundreds of tests for Covid. A new HHS policy that extricates FDA from this work - and goes further, by removing any FDA role over any lab developed test - could put this work at risk. 1/x

— Scott Gottlieb, MD (@ScottGottliebMD) August 22, 2020

A long-running debate over lab developed tests has pit bigger, more established players that typically go through more stringent regulatory oversight against those that may fly under the radar.

Gottlieb acknowledges that debate over the regulatory agency’s role with regard to lab developed tests. However, he said "it was long settled that LDTs were medical devices" subject to FDA oversight, an authority that was "articulated in countless guidances" including a 2006 guidance cleared by HHS during the administration of President George W. Bush.

Frank Pallone, D-N.J., chairman of the House Energy and Commerce Committee, on Thursday demanded a briefing from HHS Secretary Alex Azar on the policy change. Pallone in a statement called the decision "deeply concerning" as the Trump administration appears to again be interfering with FDA’s regulation of medical products. "Flooding the market with unregulated and potentially inaccurate tests will only further undermine our nation’s response efforts," Pallone said.

The American Clinical Laboratory Association, whose members developed many of the first widely available COVID-19 tests in the U.S., issued a statement on Friday that labs providing testing services during the pandemic need "clarity and certainty" about how those services are regulated.

ACLA, which represents the giant labs Quest and LabCorp among others, made the case that it is also "critical that all laboratories developing and performing testing for COVID-19 — irrespective of the regulatory authorities under which they operate — have the appropriate expertise, equipment and training to develop valid tests and deliver the accurate and reliable results that patients and clinicians depend on."

AdvaMed, representing many traditional test makers, in a statement said it backs rules that "ensure all diagnostic test developers, of both IVDs and LDTs, are subject to the same standard of test validation during the pandemic and beyond to protect patients and public health."