When the FDA finally released its draft guidance on the oversight of lab-developed tests (LDTs) in July, it ended a 10-plus-year saga to mark its regulatory stamp in that arena, but created a new one over the guidance's implementation. For that won't occur until the final guidance is released, giving opponents like the American Clinical Laboratories Association (ACLA) an opportunity to make one last push against the new regulations, and the agency and its allies time to rally their forces.
In addition to pitting anti-regulation Republicans against pro-regulation Democrats, the debate features a dizzying array of related medical associations on both sides of the issue, as well as AdvaMed member companies--manufacturers and distributors of diagnostic testing equipment--squaring off against companies that prefer to conduct the tests themselves in centralized laboratories. Currently, the former are regulated by the FDA, while the latter must comply with the federal Centers for Medicare & Medicaid Services' so-called CLIA rules.
The battle is heating up, says the FDA Law Blog, which detailed both sides' actions over the last couple of weeks.
Earlier this month, Rep. Louise Slaughter (D-NY) and the American Cancer Society Cancer Action Network, the American Heart Association, and the Ovarian Cancer National Alliance held a roundtable discussion on the topic on Capitol Hill.
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| Judith Yost, director of CMS's lab division |
"FDA's reviews are for safety and effectiveness for the marketplace and are much more extensive types of reviews, because the [CMS] reviews for analytical validity are very narrow," said Judith Yost, director of the federal CMS's laboratory division, at the event, according to the FDA Law Blog. "The clinical validity is not approached [under CMS] at all." That agency's support is crucial because the new FDA guidelines are supposed to supplement, if not replace, CMS's CLIA rules. The FDA says they are insufficient, but many conductors of LDTs disagree.
On the same day as the roundtable discussion, ACLA protested in a letter to FDA Commissioner Margaret Hamburg that "the draft guidance documents conflict with existing regulations and would impose substantial new requirements on clinical laboratories, hospitals, physicians, and other healthcare providers without complying with notice-and-comment rulemaking as required under the Administrative Procedure Act." It also said that the FDA doesn't have the statutory authority to regulate LDTs at all, points out the FDA Law Blog.
In the battle of trade and medical associations, signatories of that letter included ring-leader ACLA, the American Hospital Association, the American Association for Clinical Chemistry and the American Medical Association. Besides tough talk, ACLA took action, concurrently announcing that it is retaining two prominent attorneys "for representation on matters relating to the Food and Drug Administration's recently issued draft guidance to regulate laboratory developed tests (LDTs) as medical devices."
Meanwhile, the FDA is plowing ahead and recently announced that it will hold a public hearing on the regulation's details on Jan. 8-9, 2015, at the National Institutes of Health campus in Bethesda, MD.
The FDA Law Blog wonders whether opponents will be allowed to speak during the public comment period, for the agency says it will "determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and notify participants by December 17, 2014."
- read the FDA Law Blog blog post