This Week at FDA: HHS delays SUNSET rule, FDA begins release of Comirnaty review docs, and more

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, we saw the Department of Health and Human Services (HHS) delay the effective date of a controversial Trump-era rule. We also read that FDA has begun releasing documents related to its review of the Pfizer-BioNTech COVID-19 vaccine Comirnaty per a recent court ruling and glance at some recent reports from FDA.
 
In a Federal Register notice this week, HHS delayed effective date of the Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) rule by six months to September 2022. HHS had already proposed to withdraw or repeal the rule, which was pushed through during the final days of the Trump administration. Now, the department said it will delay the rule’s effective date to give itself more time to complete its review of the rule in light of litigation and “to preserve the status quo while the Court considers the challenge to the SUNSET final rule.”
 
We’re also reading this FDA Voices post by CDER Director Patrizia Cavazzoni that went up shortly after Rare Disease Day on the agency’s efforts to speed the development and approval of orphan drugs. In addition to providing an overview of recent activities to facilitate drug development, Cavazzoni noted the trend over the last decade towards increased orphan drug approvals. In recent years, about half of all novel drugs approved by CDER have been for rare diseases.
 
FDA has begun its release of thousands of pages of documents related to its review of Pfizer and BioNTech’s COVID-19 vaccine as mandated by a recent court decision. Endpoints notes that some of the documents that have been made public so far include the fast track designation letter and the PDUFA user fee payment cover sheet.
 
We also took a look at this report in Endpoints about Sanofi Pasteur’s recent petition to get FDA to revise the labels for two Seqirus flu vaccines, Fluad and Fluad Quadrivalent, to include a “description of results from an absolute efficacy confirmatory study that failed to meet its primary efficacy endpoints.” The vaccines were granted accelerated approval in 2015 and 2020, respectively.
 
Plus, we look this piece in STAT discussing allegations against Pfizer made by former Operation Warp Speed official Paul Mango in his new book. “Of all the companies in which we invested, Pfizer was both the least transparent and least collaborative,” he wrote. Pfizer refuted most of Mango’s claims, telling STAT they are “politically-motivated, unfair, and misleading.”
 
The National Aeronautics and Space Administration (NASA) doesn’t often make an appearance in Regulatory Focus but this recent announcement that the space agency, along with several other federal partners including FDA, have launched a multi-agency collaboration to “extend tissue viability and physiological function to a minimum of 6 months using automated engineering capabilities for real-time online readouts in complex human in vitro models, such as tissue chips or microphysiological systems.” NASA said the goals of the collaboration are to gain a better understanding of disease models, drug development, clinical trial design, chemical and environmental exposures and countermeasures, as well as physiological changes incurred in the spaceflight environment.
 
Drugs and biologics
 
This week we got an update on CBER’s expanded access request submissions in FY2021. Compared to FY2020, when the agency received thousands of expanded access requests related to COVID-19, the total number of expanded access requests the center received fell to more typical levels. CBER said it received 417 expanded access INDs and protocols in FY2021, 411 of which (98.5%) were allowed to proceed. As in past years, the vast majority of the requests were made in the form of single patient and single patient emergency INDs.
 
STAT also published an eye-opening look at a recent Form 483 handed to drug compounder Edge Pharma. The company recalled “all lots of all drugs” due to a lack of sterility assurance. STAT notes that the 483 mentions ants, spiders, “unknown residue stains” and “unknown grime” at the facility.
 
We also learned that FDA has declined to issue an emergency use authorization (EUA) for Ocugen’s COVID-19 vaccine Covaxin in patients 2 to 18 years of age. The company said it will “continue working with FDA to evaluate the regulatory pathway for pediatric use of Covaxin,” which was developed by India’s Bharat Biotech.
 
The HHS Office of Inspector General (OIG) is undertaking a review of biosimilar trends in Medicare Part B, looking at how reimbursement practices may be affecting uptake. The report is expected next year. The Biosimilars Forum welcomed the study.
 
This article in the Los Angeles Times continues a recent trend of scrutiny toward FDA’s accelerated approval program.
 
Medical devices
 
This week, CDRH released its latest MDUFA quarterly performance report, covering the center’s performance against the various MDUFA goals through Q1 FY2022. The 330-page report shows CDRH slipping against some goals nearly two years into the COVID-19 pandemic. Read more at Medtech Dive and BioWorld.
 
FDA has provided an update on its advisory panel’s recommendations for the long-term safety and effectiveness of Endologix AFX endovascular graft systems in light of the risk for Type III endoleaks. The agency notes that “lifelong surveillance and long-term postmarket data collection” is needed for all patients with abdominal aortic aneurysm (AAA) endovascular aortic repair (EVAR) devices. “Regular imaging surveillance, within 30-days of EVAR and annually thereafter, may help identify adverse events such as endoleaks, device migration, loss of patency, and failure of aneurysm sac regression before the occurrence of potentially serious and life-threatening adverse events,” FDA said.
 
CDRH also revised its appeals process guidance for medical device submissions to spin out the section on mammography facilities to its own standalone guidance.
 
This week, FDA classified screw sleeve bone fixation devices into class II (special controls) via the de novo pathway.
 
Additionally, FDA warned against the use of three unauthorized versions of COVID-19 antigen tests, Reuters reports. The tests include Celltrion’s DiaTrust COVID-19 Ag Rapid Tests, SD Biosensor Inc’s STANDARD Q COVID-19 Ag Home Test and ACON Laboratories’ Flowflex SARS-CoV-2 Antigen Rapid Test.