Friday, April 22, 2016

Dueling Publicity: FDA LDT regulation, Congressional LDT regulation

In the last couple days, the P.R. battle on FDA regulation of LDTs continues.

In an Op Ed for THE HILL (here), the President of the American Cancer Society Cancer Action Network insists that "the FDA is the most appropriate agency to evaluate the validity of these diagnostic tests."  ACS/ACN urges that attempts to derail the FDA on the hill should be avoided.  Specifically, a rider to an unrelated bill would have blocked the FDA from using its funding to regulate LDTs.  See text at bottom.

At the same time, according to the subscription journal Gray Sheet, "house appropriators"  told the FDA to "suspend further efforts to finalize LDT guidance" and "work with Congress on a new regulatory pathway."   Here.   Week by week currently, the House E&C commmitee is working on draft legislation modeled on the Diagnostic Test Working Group Proposal (DTWG).  For an open access review at Genomeweb, here.

According to Gray Sheet, Rep. DeLauro (D-CT) and Beutler (R-WA) protested the amendment, and support a rollout of FDA regulation, just as ACS/ACN does.  Similarly, American Association of Cancer Research (AACR) supports FDA regulation of LDTs (here) and cosponsors a public workshop on approaches to FDA regulation of liquid biopsy cancer tests in July 2016 (here).

Some further details after the break.

The House committee agreed to provide a new $10M in support for the FDA for ZIKA molecular test and vaccine reviews.

On April 11, Gray Sheet reporting that an Innovation Bill in the Senate lacked LDT legislation because no consensus had been reached (here).


From the House committee's report, here.

House Text:

Laboratory Developed Tests.—The FDA’s draft guidance issued on October 3, 2014, titled ‘‘Framework for Regulatory Oversight of Laboratory Developed Tests’’ (LDTs), puts forth a proposed regulatory framework that is a significant shift in the way LDTs are regulated. 

Such a shift deserves input from the public, and Congress has been working with stakeholders, constituencies, and the FDA to find common ground on regulating LDTs. The FDA’s guidance circumvents the normal rulemaking process and changes expectations for patients, doctors, and laboratories for the first time since the Clinical Laboratory Improvement Amendments Act was passed in 1988. 

The Committee directs the FDA to suspend further efforts to finalize the LDT guidance and continue working with Congress to pass legislation that addresses a new pathway for regulation of LDTs in a transparent manner,