Coalition for 21st Century Medicine Issues Statement in Opposition of Genentech Petition to Restrict Lab Use of Diagnostic Tests for Physicians an...(cribe drugs for off-label uses that have...),Health

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 i
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