By Jamie K. Wolszon -
A battle is brewing between proponents and opponents of FDA’s plans to actively regulate Laboratory-Developed Tests (LDTs), with several developments involving both camps in the past two weeks. On the proponents’ side, on November 21, FDA announced that it will be holding a public hearing on January 8-9, 2015 at the National Institutes of Health (NIH) campus in Bethesda, Maryland. That announcement came on the heels of a November 18 briefing on Capitol Hill by FDA, the Centers for Medicare & Medicaid Services (CMS) and patient groups advocating for the draft guidances (see our previous post here).
Opponents of the draft guidances were similarly active during this time period. Also on November 18, several laboratory and medical groups and laboratory directors sent FDA Commissioner Margaret A. Hamburg a letter arguing that if the agency proceeds with the framework, it must do so through notice-and-comment rulemaking. That same day, one of the signatories of the letter, the American Clinical Laboratories Association (ACLA) announced that it had hired two very prominent litigators to help the association fight the draft guidances. Although a new development will no doubt appear the moment after we post this blog, we detail the developments of the last two eventful weeks.
FDA announces January 8-9 public meeting at NIH campus in Bethesda. FDA has outlined an agenda of topics for discussion at the public workshop. According to FDA’s Federal Register notice, there will be six sessions on designated topics. The six sessions will address the following: (1) components of a test and LDT labeling considerations; (2) clinical validity/intended use; (3) categories for continued enforcement discretion, including rare disorders; (4) notification and Adverse Event Reporting (MDRs); (5) public process for risk classification of tests and prioritization for enforcement of premarket review requirements; and (6) Quality System Regulation. For each of the sessions, FDA provides questions in the Federal Register notice for which it seeks input during the meeting.
FDA states in the Federal Register notice that registrants wishing to present during a public comment session should identify which topics they wish to address. FDA states that the agency “will do its best to accommodate requests to make public comment.” Following the close of registration, “FDA 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.” It is unclear how FDA will select presenters. It also is unclear whether a presenter could address multiple topics in different sessions, and whether presenters could make a general comment that they oppose the very concept of FDA regulation of LDTs. Consistent with prior FDA statements, FDA is looking for feedback on its framework and not whether there should be FDA regulation of LDTs at all. FDA also is soliciting electronic or written comments on all aspects of the public workshop by February 2, 2015.
FDA, CMS and patient group briefing on the Hill. The American Cancer Society Action Network, the American Heart Association, and the Ovarian Cancer National Alliance, in cooperation with Rep. Louise Slaughter (D-NY), hosted a November 18 briefing to advocate for the draft guidances, according to a press release. Speakers at the briefing included Congresswoman Slaughter; Len Lichtenfeld, Deputy Chief Medical Officer for the American Cancer Society (Moderator); Elizabeth Mansfield, Deputy Director for Personalized Medicine, Office of In Vitro Diagnostics, FDA; Judith Yost, Director, Division of Laboratory Services, CMS; Richard Schilsky, Chief Medical Officer, American Society of Clinical Oncology; and Laura Koonz, Director of Policy, Ovarian Cancer National Alliance. According to a Congressional Quarterly article reporting the event, “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 laboratory services division for CMS. “The clinical validity is not approached [under CMS] at all.”
Laboratory, medical groups and laboratory directors send letter to FDA Commissioner stating that FDA must use notice-and-comment rulemaking, not guidance. The November 18 letter states 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” (APA). The letter was careful to preserve the legal argument that some of the signatories do not believe the agency has the statutory authority to regulate laboratories at all. “The FDA’s statutory authority to regulate laboratory developed testing services and the scope of the proposed guidance remains a matter of significant legal controversy, and while a number of the undersigned organizations do not waive their legal claim that the FDA lacks the statutory authority to regulate laboratory developed testing services, to the extent that it is established that the FDA does have such authority, all of the undersigned are unanimous that the overwhelming weight of legal authority dictates that the proposed new requirements outlined in the draft guidance must be issued through notice and comment rulemaking.”
Signatories of the letter included, among others, the American Medical Association (AMA), ACLA, the American Hospital Association, the American Association for Clinical Chemistry, and some leading medical institutions.
The argument that any FDA effort to actively regulate LDTs must go through notice-and-comment rulemaking is one that has repeatedly been presented to, and rejected by, FDA. For instance, in 1992, HPM submitted a citizen petition that included the argument. The Washington Legal Foundation’s Sept. 2006 and ACLA June 2013 citizen petition also included the argument. FDA denied all of those citizen petitions.
ACLA announces that it has engaged prominent litigators to help oppose FDA effort. On November 18, ACLA announced that it had retained Paul D. Clement and Laurence H. Tribe, two distinguished constitutional and APA litigators, to help the organization oppose the framework. “ACLA’s decision to hire Messrs. Clement and Tribe, and their decision to take this case, should be seen as an indication of the strength of our conviction that the merits favor protecting patients, labs, and physicians from this unjustified regulatory action,” the press release states. Retaining these two litigators can be viewed as a shot across FDA’s bow.
Undoubtedly, there will be more developments as different groups seek to bolster their position on whether FDA should regulate LDTs, and if so, how.