This Week at FDA: COVID breathalyzer gets EUA, upcoming adcomms, and more

This Week at FDAThis Week at FDA
| 15 April 2022 | By Michael Mezher 

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 authorized the first COVID-19 diagnostic that uses breath samples to detect chemical compounds associated with SARS-CoV-2 infection. We also learned that Pfizer and BioNTech plan to submit an emergency use authorization (EUA) request for a booster dose of their vaccine for children ages 5-11, and we look at some upcoming advisory committee meetings.
This week, FDA announced the authorization of a new type of test in the arsenal of diagnostics for COVID-19. The InspectIR COVID-19 Breathalyzer, a piece of equipment “about the size of a piece of carry-on luggage” that can be used in specific healthcare settings to deliver results in only a few minutes.
The authorization “is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” said Center for Devices and Radiological Health (CDRH) Director Jeff Shuren. According to FDA, the test was shown to have 91.2% sensitivity and 99.3% specificity, and has a high negative predictive value, “meaning that people who receive a negative test result are likely truly negative in areas of low disease prevalence.”
Pfizer and BioNTech this week said they plan to submit an emergency use authorization (EUA) request for a booster dose of their mRNA COVID-19 vaccine Comirnaty for children ages 5-11 in a matter of days. The companies said the booster dose showed an increase in neutralizing titers that would increase protection against the Omicron variant.
On Thursday, we learned that FDA has extended its review of Regeneron’s biologics license application (BLA) for its COVID-19 antibody REGEN-COV (casirivimab and imdevimab) by three months.
STAT reports that the Department of Justice is looking into Bausch Health’s marketing practices for four of its drugs. A legal hold memo obtained by stat notes that the department issued a Civil Investigative Demand to the company seeking documentation on its marketing of Siliq (brodalumab), Bryhali (halobetasol propionate), Jublia (efinaconazole) and Doubrii (halobetasol propionate and tazarotene), as well as financial assistance given to Medicare patients who received Siliq and the Siliq risk evaluation and mitigation strategy (REMS) program.
We’re also reading this report from Politico on dysfunction in FDA’s Center for Food Safety and Nutrition (CFSAN) following a lengthy investigation and interviews with more than sources.
Drugs and biologics
We also heard from STAT that the Institute for Clinical and Economic Review (ICER) has found Bluebird Bio’s experimental gene therapy for beta thalassemia to be cost effective up to $2.1 million. FDA will convene its Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) to review the company’s applications for that and another gene therapy targeting cerebral adrenoleukodystrophy in June.
The Center for Drug Evaluation and Research’s (CDER) Office of Generic Drugs this week updated its manual of policies and procedures (MAPP) on reviewing investigational new drug applications (INDs) for bioavailability (BA) or bioequivalence (BE) studies, or so-called Bio-INDs. The MAPP was revised for the first time since 2016 to update the procedures it lists.
FDA and the Drug Enforcement Administration (DEA) sent warning letters to two websites for illegally selling Schedule II stimulants, including mislabeled drugs marketed as Adderall (amphetamine). 
Medical devices
Earlier this week, FDA sent a letter to healthcare providers advising them of the intended use of imaging software for intracranial large vessel occlusion. The agency said that some providers “may not be fully aware that LVO CADt devices are intended for prioritization and triage only,” and provides a set of recommendations to ensure that the devices are not used inappropriately.
CDRH has called in its Patient Engagement Advisory Committee for a two-day meeting in July to discuss a wide range of augmented reality (AR) and virtual reality (VR) medical devices being deployed in various healthcare settings, including diagnostics, clinical decision-making support tools, and surgical support, among other applications.
“These devices have novel attributes and considerations for the end users that impact FDA's evaluation of the device's safety and effectiveness. The novel attributes of digital health visualization, tracking techniques, embedded software among other factors present unique challenges for pre- and postmarked evaluation. The recommendations provided by the committee will address factors FDA and industry should consider when evaluating the benefits, risks, and the extent of uncertainty in the benefit-risk information for AR/VR medical devices,” FDA writes.
FDA also released its latest third-party review organization performance report containing data from Q2 FY2022.


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