This Week at FDA: A ‘reasonable expectation’ for user fee reauthorization

This Week at FDAThis Week at FDA | 09 September 2022 | By

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. With Congress back in session and the end of the fiscal year rapidly approaching, attention once again turns to user fee reauthorization and appropriations.
 
Both Politico and BioCentury reported this week that an FDA spokesperson said the agency has a “reasonable expectation” that its user fee programs will be reauthorized before it needs to lay off any user fee-funded staff. The agency has said it can use carryover funds from the current user fee programs into November to delay notifying staff of impending layoffs. One potential path for user fee reauthorization: strapping the user fee package to a continuing resolution that will likely be passed in lieu of a full-year appropriations bill, Roll Call reports.
 
This week, we also saw an FDA advisory committee reverse its position on Amylyx’s amyotrophic lateral sclerosis drug, voting 7-2 in favor of approving the drug based on new analyses and data from a study of the drug to treat Alzheimer’s disease. After the committee voted 6-4 against the drug’s approval in March, Amylyx went to FDA with new analyses showing the drug could increase survival by 10 months, along with biomarker data from a Phase II study in Alzheimer’s disease. FDA delayed its decision and reconvened its advisory committee to review the new data. At the outset of the hearing, Billy Dunn, director of FDA’s Office of Neuroscience, called on the company to pledge to withdraw the drug, if approved, if its ongoing confirmatory found it to be ineffective. Read more from Stat and The Wall Street Journal.
 
We also saw FDA warn of the risk for squamous cell carcinoma (SCC) and certain lymphomas in scar tissue around breast implants. In a safety communication sent on Thursday, the agency said that the occurrence of SCC and lymphomas in the tissue around breast implants is rare, though it is alerting the public to those risks out of an abundance of caution. FDA noted that the reports are different from breast implant associated anaplastic large cell lymphoma (BIA-ALCL).
 
Drugs & biologics
 
FDA’s drug and biologics centers on Wednesday said they have accepted the first submission to the agency’s Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot. The pilot, launched nearly two years ago, is meant to promote the development of new drug development tools (DDTs) that fall outside the agency’s existing DDT qualification programs. The first submission accepted to the program “is for a tool that proposes to evaluate off-target protein binding for a variety of biotherapeutic modalities, potentially reducing or eliminating the need to conduct some of the more standard nonclinical toxicology tests.”
 
On Wednesday, FDA announced it will convene its Pulmonary-Allergy Drugs Advisory Committee on 6 October to discuss an emergency use authorization (EUA) request from Veru Inc. for the company’s sabizabulin oral capsule to treat SARS-CoV-2 infection in patients with moderate to severe COVID-19 with a high risk of acute respiratory distress syndrome (ARDS).
 
The agency also released a Form 483 handed to South Korean drugmaker Hugel, Inc., noting several good manufacturing practice (GMP) issues, including inadequate C. botulinum containment measures and lax environmental monitoring practices following observed during an inspection in August 2021.
 
On Thursday, FDA announced it has hired David Kaslow to head its Office of Vaccines Research and Review, following the retirement of Marion Gruber, who left the agency in October 2021 after objecting to the Biden administration’s push to authorize COVID-19 vaccine boosters.
 
Medtech
 
In other device news, FDA alerted healthcare providers about the risk of clip lock malfunctions with Abbott MitraClip devices and announced a recall of Philips Respironics’ BiPAP and CPAP machines due to a potential safety issue with magnets used in the devices’ headgear.

 

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