by
Joan Trombetti, Writer | January 07, 2009
Coalition for 21st Century Medicine
The Coalition for 21st Century Medicine strongly opposes the citizen petition filed by Genentech, Inc. on December 5, 2008, seeking to restrict the ability of laboratories to offer diagnostic tests to physicians and patients. The request threatens innovation in laboratory tests, would harm patient care and rests on flawed scientific and legal premises.
The Coalition's mission is to encourage the research, development, and commercialization of innovative diagnostic techniques. In contrast, the petition, by requesting that the FDA approve all laboratory tests, would delay the introduction of many critically needed diagnostic tests, and prevent others from ever being available. Further, although implied to be narrow, the petition is sweeping in scope.
The petition states that the Food and Drug Administration (FDA) should regulate all laboratory developed tests (LDTs) "for use in drug or biologic therapeutic decision making." LDTs are developed precisely for the purpose of helping physicians make therapeutic decisions for their patients, including the decision of which drug to prescribe. The overwhelming majority of LDTs fall within the scope of the petition.
Genentech's citizen petition relies on several incorrect assumptions. One of the most fundamental errors is that FDA review and approval is needed for all LDTs used in therapeutic decision-making "to ensure that claims made for the tests are scientifically proven." Genentech wrongly asserts that FDA approval is a prerequisite for claims to be considered "scientifically proven." FDA approval is not needed for a LDT's performance to be demonstrated.
There are many other methods of establishing a LDT's performance, such as the publication of reproducible research findings in peer-reviewed publications. Doctors routinely use peer-reviewed published literature in making therapeutic decisions, including the decision to prescribe drugs for off-label uses that have not been approved by FDA.
In seeking to require FDA approval of all LDTs used to make therapeutic decisions, Genentech relies on statements which it alleges are "unsubstantiated" relating to LDTs affecting usage of its own products. There is a vast difference between not knowing how much data support a particular claim, and whether the claim is actually unsubstantiated.
A lack of information about some LDTs does not justify a revolutionary change in the regulatory regime for laboratories. Moreover, imposing FDA regulation is not needed to redress false or misleading claims.
