This Week at FDA: Agency won’t extend LDT rule comment period, drops new guidances, and schedules meetings

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week FDA declined to extend the comment period for its proposed laboratory-developed test (LDT) rule, published a couple of guidances to transition its COVID-19 policies, and scheduled several important meetings for next week.

Probably the biggest news this week was a one-paragraph statement from the US Food and Drug Administration (FDA) stating that the agency has declined to extend the comment period for a controversial proposed rule that would phase out its regulatory discretion for LDTs. The docket for the proposed rule, slated to close on 4 December, has already amassed more than 1,000 comments.

Hyman, Phelps and McNamara's FDA Law Blog, published an interesting analysis this week on whether FDA has the legal authority to regulate LDTs as medical devices. The piece noted that the agency posits three legal arguments in the proposed rule that it claims are clear-cut, but that must to be adjudicated by the courts, which can't happen until the rule is finalized and challenged.

During the COVID-19 pandemic FDA implemented several policies to allow greater flexibilities for certain products to come to market faster and make modifications without additional regulatory burdens. As the public health emergency ended earlier this year, the agency published a slew of guidances, including two just this week that help transition those products to traditional marketing.

One is a leapfrog guidance that extends FDA’s pandemic-era policy of allowing manufacturers to make certain modifications to products that are on the market under a premarket approval (PMA) or humanitarian device exemption (HDE). The move is meant to alleviate supply chain disruptions and device shortages.

FDA finalized a guidance on transitioning clinical electronic thermometers from the pandemic-era policies to normal operations. In conjunction with the guidance, the agency is proposing to exempt clinical electronic thermometers without telethermography or continuous temperature measurement functions from premarket notification requirements and plans to pull the guidance after a final notice has been published.

FDA also dropped several guidances at the end of the week, including a guidance on submitting patient-reported outcome (PRO) data from cancer drug trials and another one on clinical outcome assessment (COA) data that use Item Response Theory (IRT) and compliments the drug center's Patient-Focused Drug Development (PFDD) Methodological Guidance Series.

FDA also reissued a guidance on how to request a review of its decision not to issue certain export certificates to device manufacturers. It updates details on what information the agency will provide to companies that have had a request for a Certificate to Foreign Government (CFG) denied, and the process to contest the denial.

Several FDA meetings are coming up next week, including a webinar that will discuss using decentralized clinical trials (DCT) to make it easier for patients to participate in studies, and an online presentation on evaluating 5G-enabled medical devices. It is also hosting several hybrid meetings, including one on using modeling and simulation to select dosages for combination therapies and new indications in partnership with the International Society of Pharmacometrics (ISoP), a meeting to discuss endpoints and trial designs for kidney transplantation drugs, and a meeting on Positron Emission Tomography (PET) drug manufacturing.

FDA has again extended the life of its Patient Engagement Advisory Committee (PEAC) by two years. The committee which has been instrumental in including patient preference information in product submissions and regulatory decisions was set to expire last month but now will continue to operate until at least 6 October 2025.

Reuters reported that FDA's Cellular, Tissue, and Gene Therapies Advisory Committee met on Tuesday, 31 October to discuss exagamglogene autotemcel (exa-cel), made by Vertex Pharmaceuticals and CRISPR Therapeutics to treat sickle cell disease. The treatment uses the gene-editing technology CRISPR, and the panel agreed that if it is approved by FDA, the manufacturer could use a proposed 15-year patient follow-up to evaluate safety outcomes.

Drugs & Biologics

FDA announced it has approved Amgen's inflammatory disease biosimilar Wezlana (ustekinumab-auub) that is interchangeable with Janssen's Stelara (ustekinumab). It is indicated to treat certain patients with plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.

FDA's is hosting a webinar on 9 November on the work being done by the non-profit drugmaker Rapidly Emerging Antiviral Drug Development Initiative (READDI) that is working to develop antiviral drugs in response to global pandemics. The webinar will present information on the clinical trial methodologies being used by READDI to develop drugs during global crises.

Medtech

The Center for Devices and Radiological Health (CDRH) has published 14 questions for stakeholders regarding how digital health technologies (DHT), including artificial intelligence/machine learning (AI/ML), might be used to detect prediabetes and undiagnosed type 2 diabetes. The questions address broad topics such as community engagement and consortia efforts, science and innovation, outcomes, and clinical issues.

FDA published the third planned interim analysis of Bayer’s Essure birth-control implant. The data reaffirm past analyses that women who used the product had higher rates of gynecologic surgical procedures and endometrial ablation compared to those who underwent laparoscopic tubal sterilization (LTS). The agency asked the German drugmaker to conduct a five-year postmarket follow-up study in 2016 after receiving reports raising safety concerns with women who used the birth-control device.

FDA also updated its "Information for Patients and Health Care Providers: Essure" website with the latest analysis to keep patients abreast of its findings.

FDA announced it will hold a webinar on 5 December to discuss its Antimicrobial Susceptibility Test System Devices final guidance that was published in September. The guidance is meant to clarify the agency's thinking on how manufacturers of such devices can use predetermined change control plans (PCCPs), its enforcement policy for legacy devices and more.

FDA's Radiological Devices Panel (RDP) will convene on 7 November to discuss classifying blood irradiator devices intended to prevent metastasis. The devices are currently considered unclassified pre-amendments devices to class III devices.

This Week at FDA: Agency won’t extend LDT rule comment period, drops new guidances, and schedules meetings

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