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 rule making 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.

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