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This Week at FDA: House advances user fee bill, FDA’s enterprise modernization ambitions, and anothe


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. It was a busy week for FDA on the Hill again, with FDA Commissioner Robert Califf testifying before the House Appropriations committee on Thursday and the House Energy & Commerce committee voting unanimously to send FDA user fee and reform legislation to the House floor.
 
On Thursday, Califf pressed the House Appropriations subcommittee that oversees the agency’s budget for more resources and greater authority to monitor supply chains in the wake of the ongoing infant formula crisis. The Biden administration has requested $8.4 billion in budget authority for FDA in FY2023.
 
“This crisis has shown us the impact of having a single manufacturer cease production for a brief period, and unless we strengthen the resiliency of our supply chain, we could be one natural disaster, quality mishap, or cyber attack from being here again,” Califf warned the committee.
 

We also saw the House Energy & Commerce hold its full committee markup of legislation to reauthorize FDA’s user fee programs one week after the health subcommittee signed off on the package. The full committee voted 55-0 to move the legislation forward, though the timing of floor debate is still unclear, as Politico reports. The markup followed the release of the Senate Health, Education, Labor and Pensions committee’s discussion draft of its user fee reauthorization package, which contains markedly different riders than the House version that will need to be ironed out. Still, top lawmakers have signaled that they intend to get the legislation passed before the current user fee agreements expire.
 
FDA also released a new Enterprise Modernization Action Plan (EMAP), which continues the work laid out in the agency’s recent technology and data modernization action plans. The plan lays out steps to overhaul the agency’s business processes to promote operational efficiency and the use of data. The plan includes provisions to stand up an Enterprise Transformation Operation (EPO) team to develop a “standardized approach to analyze, recommend, and implement agreed-upon enterprise business programs that solve shared, cross-agency issues.” The plan also seeks to improve alignment across the agency on broad strategic initiatives.
 
“Our IT and data modernization efforts form a strong foundation for the future, and will continue to evolve: changes at the data and technology levels must be accompanied by improved business operations to achieve our goals. The EMAP describes our plans to shape the FDA’s future by delivering successful cross-agency efforts that optimize common and essential business processes,” FDA Principal Deputy Commissioner Janet Woodcock wrote.
 
Plus, we learned that Califf has asked Woodcock to shift her focus as principal deputy commissioner to several new topics, including food and nutrition, inspectional oversight, IT and operations. Califf said her revised role would have the former CDER director “serve as a strategic thought partner to advance key initiatives/modernization in these areas.” As Politico reports, not everyone is pleased with her heightened role overseeing food and nutrition amid multiple controversies. Endpoints also caught that the Office of New Drugs and the Office of Generic Drugs are absent from the list of offices Woodcock will be liaising with.
 
Drugs & biologics
 
Earlier this week, FDA expanded eligibility for Pfizer and BioNTech’s COVID-19 vaccine booster to children ages 5-11.
 
On Thursday, FDA released its latest quarterly batch of draft and revised draft product-specific guidances (PSGs) for generic drugs. This batch contains 24 new and 13 revised draft guidances, including 14 that cover complex products, nine of which have no generic equivalent. In total, 26 of the guidances address products without generic competition.
 
The agency also finalized its 2013 guidance on safety considerations for container labels and carton labeling design to minimize medication errors earlier this week.
 
FDA sent warning letters citing data integrity violations to two US-based firms, Specialty Process Labs LLC and Colorful Products Corporation earlier this month. The warning letters, posted to the agency’s website this week, both focus on issues with the companies’ computer systems.
 
The agency also proposed new rules to related to postmarketing safety reporting and labeling requirements for medical gases. “This action, if finalized, will clarify the regulatory obligations of entities that manufacture, process, pack, label, or distribute certain medical gases, as well as reduce regulatory burden in this area. This proposed rule is intended to establish requirements that are more specifically tailored to the medical gas industry,” FDA said.
 
FDA’s National Center for Toxicological Research has released its 2021 annual report.
 
 
CBER has also released data from its inspections program for human cells, tissues, and cellular and tissue-based products (HCT/Ps), noting a sharp decrease in the number of inspections performed during the COVID-19 pandemic. In FY2021, the center carried out just 159 inspections, compared to 563 in FY2019.
 
 
Medical devices
 
FDA announced a new voluntary pilot program for 510(k)s on Friday to “streamline certain changes to ethylene oxide (EtO) sterilization processes and facilities. The 510(k) sterility change master file pilot program builds on FDA’s effort to promote new medical device sterilization methods due to environmental concerns related to the use of EtO. FDA said the pilot will offer a pathway for sterilization providers to submit a master file for the agency to review; such master files will be accepted when FDA determines “that there is not a likelihood that switching from a fixed chamber ethylene oxide (EtO) sterilization method to the sterilization method described in the Master File could significantly affect the safety or effectiveness of a 510(k)-cleared device that meets the product definition in the Master File.”
 
What we heard this week
 
CBER Director Peter Marks told ABC News this week that FDA will likely made a decision about future COVID-19 vaccine composition shortly after its Vaccines and Related Biological Products Advisory Committee meets late next month. We’ll have to make some decision by early July to make sure that the manufacturers know what we’re looking to do, so that they know what they have to start producing in large quantities,” Marks said to ABC.
 
Marks is also reportedly eyeing an “intermediate pathway” for certain cell therapy products, according to Inside Health Policy, that would bridge the gap between the agency’s HTC/P regulations and full-licensure.
 
Bloomberg Law reports that Woodcock believes FDA will be “deeply involved” in work done by the Advanced Research Products Agency for Health (ARPA-H), once the nascent agency is up and running.

© 2022 Regulatory Affairs Professionals Society.



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