Following the July 31, 2014 notification to Congress (see prior post here), FDA wasted no time before formally issuing the draft laboratory-developed test (LDT) Guidance Documents. On October 3, 2014, just four days after the statutorily imposed 60-day notification period to Congress ended, FDA will formally publish notice of the draft “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” (the Framework Guidance) and “FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs)” (the Notification Guidance) in the Federal Register seeking public comment.
A lot has happened since FDA’s notification to Congress in late July. For instance, on Tuesday September 9, 2014, the House Committee on Energy and Commerce Subcommittee on Health held a hearing on the documents provided as part of the notification to Congress. At the hearing, which lasted for hours, several members of the subcommittee grilled FDA Center for Devices and Radiological Health (CDRH) Director Jeff Shuren at length. The critical questions from representatives focused on the following areas: FDA’s decision to issue the framework using guidance instead of notice-and-comment rulemaking, bypassing, among other requirements, a regulatory flexibility analysis and economic impact analysis; questions about FDA’s statutory authority to regulate LDTs as medical devices; FDA’s lack of informal outreach to lawmakers prior to officially notifying Congress of the framework; the source of FDA resources for the increased regulation; FDA’s basis for believing that there are flawed LDTs on the market; duplication between FDA regulation and CLIA; tax implications of the framework; obstacles to innovation; and inconsistencies between the current registration and listing regulations and FDA’s proposed framework.
Also at the congressional hearing, Alan Mertz, President of the American Clinical Laboratory Association (ACLA), criticized the proposed framework as announced in the notification to Congress. ACLA issued a press release on September 30, 2014, responding to FDA’s formal issuance of the draft guidances. In the press release, the association cited its concern that “unnecessary and duplicative regulation could delay patient access to life saving treatments and compromise America’s leadership in diagnostic discovery.” On the other hand, Andrew Fish, Executive Director of AdvaMed Dx, testified at the hearing in favor of FDA regulation of LDTs.
Just one day after the congressional hearing, on September 10, 2014, Alberto Guiterrez, Director of the Office of In Vitro Diagnostics and Radiological Health at CDRH, presented FDA’s proposed framework to a webinar hosted by the American Association for Clinical Chemistry. Dr. Gutierrez asserted that the current LDT regulatory model presented “significant adverse health consequences” and led to “unnecessary healthcare costs.”
Despite the flurry of activity since FDA notified Congress, substantively, the Framework Guidance is unchanged from what was provided to Congress on July 31, with two exceptions: (1) the definition of a companion diagnostic has been revised for consistency with the final guidance document, “In Vitro Companion Diagnostic Devices;” and (2) the “Traditional LDT” factor regarding use of only legally marketed components has been clarified to require only use of components (including instruments) that are legally marketed for clinical use. In the Federal Register notice, among other comments, FDA specifically requests public comment on the following topics in the Framework Guidance:
- Whether the healthcare system criterion in the Traditional LDT and LDT for Unmet needs can be omitted.
- Standard for determining if an LDT is for a Rare Disease (e.g., use of the HUD standard or an alternative standard.)
- Quality System Regulation phase-in timeline.
- Notification – whether a single notification from a healthcare system is sufficient if the test is being run in multiple labs and whether some LDTs should not require registration and listing.
The draft Notification Guidance is substantively the same as the version that was provided to Congress in late July. Interestingly, we noticed that FDA may have significantly underestimated the number of laboratories affected by the draft guidances. In the Federal Register notice for the draft Notification Guidance, FDA estimates that “approximately 650 manufacturers [of LDTs will] provide notification regarding approximately 17 LDTs each.” Based on our experience, we expect that closer to approximately 2,000 laboratories will be affected by these guidance documents, although how many will choose to notify FDA is anyone’s guess.
FDA intends to hold a public webinar on October 23, 2014 at 2:00 p.m. regarding the draft guidance documents, and FDA will answer questions. The meeting has been announced on FDA’s website and pre-registration is not required. Additionally, the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS), which administers most of CLIA, announced that they will be holding a public workshop on November 4-5, 2014 to discuss the proposed framework in Atlanta, Georgia (and will also be available via webcast).
Recognizing that the public will require significant time to prepare and submit comments on these important draft guidance documents, FDA has allotted a 120-day review period for the draft LDT guidances. The comment period for the proposed LDT guidances will end on January 30, 2015. This time frame is longer than the typical 60-day comment period for a draft guidance document.
We fully expect that FDA will have its hands full reviewing (and possibly addressing) all of the comments to these two draft guidance documents. We also expect FDA to receive a diverse set of views and opinions on this highly controversial topic.