In the last couple days, the P.R. battle on FDA regulation of LDTs continues.
PRO FDA LDT
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.
AGAINST FDA LDT
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.
PRO FDA LDT
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.
SENATE STALLS FOR TIME
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.
Laboratory Developed Tests.—The FDA’s draft guidance issued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
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,