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Congressional Subcommittee Questions Legality of FDA's RUO Guidance, Calls for Agency Response


Members of a US House of Representatives subcommittee have called on the US Food and Drug Administration to respond to "significant concern" regarding the agency's draft guidance document on research-use-only and investigational-use-only diagnostic products.

In a letter addressed to FDA Commissioner Margaret Hamburg March 19, four members of the House Committee on Energy and Commerce's Subcommittee on Health raised concerns about the content of the FDA's RUO draft guidance document and called on the agency to respond to specific questions about the legality of its drafted regulatory stance by April 9.

The FDA issued its draft guidance on RUO/IUO products last June in an effort to close a regulatory loophole that has allowed companies to commercialize diagnostics by circumventing the agency's medical device rules (PGx Reporter 6/8/2011).

In the new letter, the subcommittee members argue that the guidance appears to represent a "disregard of current law on 'intended use,' " because the FDA has indicated that it will consider "actual use" when determining "intended use" of RUO products.

Further, the group contends that the guidance "exacerbate[s]" this issue because it requires manufacturers to "police end users of their products."

The letter was signed by Subcommittee Chairman Joseph Pitts (R-PA), Vice Chairman Michael Burgess (R-TX), and Representatives Cathy McMorris Rodgers (R-WA) and Brian Bilbray (R-CA).

"The definition of 'intended use' is essential to the interpretation of the Federal Food, Drug, and Cosmetic Act," the representatives wrote in their letter, arguing that considering actual use in evaluating RUO products has consequences for all FDA-regulated products, not just in vitro diagnostics labeled as RUO.

This is not Burgess's first experience challenging the FDA's role in regulating diagnostics. The Texas representative introduced a bill last year called the "Modernizing Laboratory Test Standards for Patients Act," seeking to keep regulation of laboratory-developed tests under the purview of the Centers for Medicare & Medicaid Services in response to the FDA's intention to lift its longstanding practice of "enforcement discretion" over LDTs (PGx Reporter 10/19/2011).

Burgess and his co-authors on the recent letter suggest the RUO guidance represents a "policy shift," extending the regulatory reach of the FDA "into clinical laboratories."

"Instead of extending its regulatory reach the FDA should respect Congressional intent, focus on its core mission and prevent duplicative efforts, but enabling CMA to enforce CLIA," the group wrote.

The authors also suggest that the FDA's process for implementing the guidance is itself a source of legal concern, arguing that the agency "has established the practice" of issuing guidances when it should instead rely on regulation.

Though the FDA has represented that the RUO guidance contains "non-binding recommendations," the congress members argue that the agency cited the draft guidance in a warning letter a "mere two weeks" after the comment period closed. The authors don't specify what this warning was, but most likely refer to a letter sent to International Immuno-Diagnostics in September.

Burgess and his co-authors are not alone in taking issue with the FDA's growing use of guidance documents. Jeffrey Gibbs, a healthcare lawyer at Hyman, Phelps & McNamara, expressed concern earlier this year that the FDA may be choosing to issue more guidance documents instead of going through the rulemaking process so that it doesn't have to address industry objections to its regulatory practices (PGx Reporter 1/18/2012).

Burgess and his congressional colleagues call for a response from the FDA to ten specific questions by April 9.

Among these questions, they ask the agency to explain how considering intended use "comports with established legal precedent." The also ask the agency to defend the legal basis for holding manufacturers accountable for how customers use their products.

Echoing concerns raised by lab groups, the congress members also ask why the guidance does not make separate accommodation for tests used for rare diseases or emerging public health threats, as well as why the agency did not provide a transition period for companies to come into compliance.

The group also asks the FDA to indicate whether and how it will respond to public comments received on the draft guidance and to explain how the document can be "unbinding" if it is cited in warning letters to companies.

Finally, the representatives ask whether the agency has conducted an economic impact assessment to determine the effect of the new requirements on "laboratories, manufacturers and innovation."