FDA Regulatory News and Trends

Welcome to FDA Regulatory News and Trends, designed to help you identify significant legal developments and navigate the evolving business, legal and regulatory world.

FDA authorizes first commercial test kit for monkeypox. On October 7, the FDA announced that it has issued an Emergency Use Authorization to Abbott Molecular for a real-time polymerase chain reaction (RT-PCR) test intended to detect monkeypox DNA by using lesion swab specimens from individuals suspected of monkeypox virus infection. The test is the first commercial test kit to be authorized by the agency for the detection of monkeypox, following an Emergency Use Authorization received by Quest Diagnostics for a laboratory developed test, which can only be used in Quest-designated labs. The Abbott test kit, in contrast, can be purchased commercially and run in any CLIA moderate or high complexity lab. All the steps needed to run the test, such as sample preparation and PCR assembly, amplification, and result calculation are performed automatically by Abbott’s Alinity m System, which was previously available. Abbott designed that system to increase the throughput of molecular diagnostics testing and with this EUA is making available a monkeypox assay for that proprietary system.

Mandatory biennial FDA food facility registration must be completed by December 31. In accordance with the Food Safety Modernization Act, companies that own or operate a domestic or foreign food facility are required to register their facility with FDA and renew their registration every two years. Owners, operators, or agents must complete this registration process online through their FDA Industry Systems account, unless FDA has granted a waiver to submit a paper submission. The registration and renewal period is open until December 31, 2022. Find out more in our alert.

FDA and NIH plan public workshops on devices involved in opioid use disorder. The FDA and the National Institutes of Health announced on September 29 that they plan to host two public workshops in November 2022 on opioid use disorder, including topics on diagnostic and monitoring devices for opioid use disorder and devices predicting risk of the disorder. The announcements come after a new FDA guidance that would require pre-market review for devices intended to predict or assess risks for opioid use disorder. The purpose of these workshops is to promote medical device innovation through discussions with stakeholders and provide a forum for device developers to discuss total product life cycle challenges.

Congress passes funding bill with FDA funding but no additional regulatory provisions. On September 30, Congress passed a crucial stopgap funding bill that includes the much-needed reauthorization of the Food and Drug Administration’s user-fee programs, which were about to expire after a five-year period ended. The reauthorization bill averted layoffs at the FDA and permitted the agency’s approval processes for drugs and medical products to continue. However, the bill did not contain many provisions included in the draft legislation, such as dietary-supplement regulatory frameworks, enhanced regulation over in-vitro clinical tests, accelerated approval reforms and many other proposals. These were jettisoned in order to secure Republican support for the funding bill. Immediately after the House passed the bill by a vote of 230-201, FDA Commissioner Robert Califf emailed agency staff thanking them for their patience and continued service. In late July, he had warned staff that if Congress didn’t pass a user fee reauthorization bill, the agency would have to send out letters warning staff they may be laid off.

HHS OIG notes that many drugs with accelerated FDA approval lack full confirmatory trials. The US Department of Health and Human Services Office of Inspector General found that of 278 accelerated FDA approvals granted between 1992 and 2021, 104 had incomplete confirmatory trials, according to a report issued on September 29. The report noted that one-quarter, or 70, of all accelerated approvals, occurred in 2020 and 2021. The 139 applications that had completed confirmatory trials took an average of 48 months to be finished. Of the 104 with incomplete confirmatory trials, 34 percent are past their initially planned dates of completion. They are, on average, 20 months past their expected completion dates. The FDA’s accelerated approval pathway allows the agency to approve certain drugs for serious or life-threatening diseases that offer benefit over existing treatments before the confirmatory trials are finished. They are typically based on surrogate endpoints, such as biomarkers that infer benefit, for which actual clinical benefit is not proven. Accelerated approvals require companies to conduct post-approval clinical trials to validate the drugs’ clinical benefit or the approval may be rescinded. The report concludes that insurers– including Medicare and Medicaid – are paying billions for treatments that are not verified to have clinical benefits.

New guidance discusses ethical considerations when children are involved in clinical trials. On September 23, the FDA issued a draft guidance that, when finalized, will provide the agency’s perspective on the ethical considerations for including and protecting children in clinical trials. The guidance is intended to assist industry, sponsors and institutional review boards when considering the enrollment of children in clinical investigations of drugs, biological products, and medical devices. Clinical investigations in children are essential for obtaining data on the safety and effectiveness of drugs, biological products, and medical devices in children and to protect children from the risks associated with exposure to medical products that may be unsafe or ineffective. Children are a vulnerable population who cannot consent for themselves and who therefore are afforded additional safeguards when participating in a clinical investigation. Such safeguards are an essential requirement for the initiation and conduct of pediatric investigations as part of a medical product development program. The draft guidance is part of a broader FDA initiative, including a recent draft guidance “General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products” designed to address exposure-response considerations in pediatric clinical pharmacology assessments.

FDA announces modernized rules on oversight of research. The FDA announced September 28 that it is proposing to amend its regulations to modernize, simplify, and enhance the current system for oversight of FDA-regulated human subject research. This proposed rule, if finalized, would harmonize certain sections of FDA's regulations on human subject protection and institutional review boards (IRBs), to the extent practicable and consistent with other statutory provisions, with the revised Federal Policy for the Protection of Human Subjects (the revised Common Rule), in accordance with the 21st Century Cures Act. The same day, the FDA announced that it is proposing to replace current requirements for FDA-regulated cooperative research with new requirements that would require any institution located in the United States participating in FDA-regulated cooperative research to rely on review and approval by a single institutional review board (IRB) for that portion of the research that is conducted in the United States, with some exceptions. This would also help harmonize the FDA’s regulations with the revised Common Rule.

Guidance issued on post-market device studies. On October 7, 2022, FDA issued two final guidance documents regarding post-market device studies, Procedures for Handling Post-Approval Studies Imposed by PMA Order and Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act, which supersede the 2009 guidance on Post-Approval Studies (PAS) and the 2015 guidance on the section 522 studies. In general, both final guidances align with the 2021 draft guidances, setting a clear timeline for the device developer to submit a post-market study protocol and provide timely updates regarding enrollment status and study progress. Under the final guidances, if a PAS or a section 522 study is needed, the developer must submit a PAS protocol/post-market surveillance (PS) plan within 30 days of the PMA approval/receiving the section 522 study order. In addition, FDA specifies that the agency “generally does not intend for manufacturers to routinely modify [the PAS protocol or PS plan] to adjust study milestones.” FDA sets slightly different enrollment milestones between PAS and section 522 studies. For PAS, FDA recommends that the first subject be enrolled within six months of the study protocol approval, with 20 percent of subjects enrolled within 12 months, 50 percent of subjects enrolled within 18 months, and 100 percent of subjects enrolled within 24 months. For section 522 studies, FDA recommends the first subject be enrolled within 15 months of the study protocol approval, with 20 percent of subjects enrolled within 18 months, 50 percent within 21 months, and 100 percent within 24 months. Should a developer fail to meet the enrollment milestones, FDA “expects sponsors to act with due diligence to mitigate continued study delays” and will consider “the sponsors’ mitigations to address study delays.” As for study reports, both PAS and section 522 studies need to provide interim reports and the final report. Interim reports are generally due every six months for the first one to two years, depending on the nature of the study, and annually thereafter. Test developers should also provide “proposed interim summary data” to be posted on FDA’s database. Failure to comply with a 522 order or PSA study timelines could result in enforcement action by the FDA.

Approvals policy for COVID-19 tests is updated. On September 27, the FDA announced updates to its COVID-19 test policy to address current public health testing needs. Over the last two years, more than 400 COVID-19 tests have been granted emergency use authorization. The FDA says that, taking into account all these at-home tests, tests for use at points of care such as health clinics, and laboratory-based tests, there are more than enough tests to meet the healthcare system’s needs. Accordingly, the agency has revised its approach to approving such tests: rather than seeking emergency use authorizations, COVID-19 test developers are being encouraged to pursue a traditional premarket review pathway. The FDA intends to prioritize its review of emergency use authorization requests on COVID-19 diagnostic tests that are likely to have a significant public health benefit or to fulfill an unmet need. This could include novel technologies like the use of breath samples, or unique features like the ability of a test to detect a new SARS-CoV-2 variant. This policy update came only days after HHS-OIG issued a report critical of FDA’s EUA deployment during the early phases of the COVID-19 pandemic.