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. Genentech maintains 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. The Federal Trade Commission has jurisdiction over that type of misconduct, as do the existing state agencies that regulate laboratories. Concerns about allegedly inaccurate statements can be readily — and efficiently — addressed within the existing regulatory framework.
The petition entirely ignores that a rigorous, well-established regulatory system already exists for LDTs. Laboratories and their tests need to meet the demanding requirements under the Clinical Laboratory Improvement Amendments (CLIA). They are also regulated by various states, as well as professional societies. Superimposing FDA approval of LDTs on top of the existing regulatory requirements would result in redundant — and even conflicting — regulation.
The Coalition for 21st Century Medicine, as well as many other organizations, questions whether FDA has the authority to regulate LDTs. However, as Genentech acknowledges, even if the FDA were to seek to regulate LDTs, the agency needs to proceed through notice-and-comment rulemaking. Until that process is completed, FDA cannot take enforcement action against laboratories for offering LDTs. Singling out individual laboratories for ad hoc enforcement, based on unstated criteria, can only result in arbitrary and capricious decisions. Asserting that FDA rulemaking is "a complex, lengthy process," Genentech requests that FDA punish companies before developing its regulations. The rights of laboratories to due process and fundamental fairness cannot be subordinated to a desire for haste.
Overturning the existing regulatory regime for LDTs would impose huge costs on laboratories. Even when a company possesses the data necessary to obtain FDA approval, companies still incur huge regulatory costs — and delays — in navigating the FDA approval process. Laboratories would incur significant additional costs to develop and implement systems that meet FDA’s Good Manufacturing Practice regulations. Requiring FDA approval or clearance of every LDT used to make drug-related therapeutic decisions would cost the health care system a staggering amount of money. Nevertheless, Genentech’s single paragraph on Economic Impact essentially ignores all of these direct economic costs, as well as all the health care costs that the health care system will bear because new LDTs will not be available. Genentech also entirely overlooks the costs to FDA of reviewing these submissions, and the impact on FDA’s ability to handle its existing workload of diagnostic products.
