This Week at FDA: New guidance, a new super office, and farewell to Janet Woodcock

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, the agency published several guidances, elevated a key office in its medical device center to a super office, and sought participants for its fledgling quality management maturity program.

Before we get to that news, we want to acknowledge the retirement of FDA Principal Deputy Commissioner Janet Woodcock next week after more than three decades of service at the agency. Our Senior Editor Joanne Eglovitch sat down with Woodcock for an exclusive interview on Thursday that our readers can look forward to next week.

This week, FDA published guidances meant to streamline its abbreviated new drug application (ANDA) review process and outlining its thinking on coatings for orthopedic devices.

FDA also published a revised question-and-answer format draft guidance on how it conducts remote regulatory assessments (RRA). The agency notes that it "uses RRAs to conduct oversight, mitigate risk, meet critical public health needs and help maximize compliance of FDA-regulated products."

The Department of Health and Human Services (HHS) held a virtual meeting this week with Pfizer and healthcare provider groups, including the American Medical Association (AMA) and the American Academy of Family Physicians, on the transition of COVID-19 oral antivirals, such as Paxlovid (nirmatrelvir/ritonavir), to commercially marketed products. While Medicare and Medicaid patients will continue to get the drug for free until the end of the year, HHS said no patient should be forced to pay the full out-of-pocket cost of the drug.

In a STAT News op-ed, former FDA official John Whyte writes that the US should not replace paper prescription drug information with digital formats. He said that there's a growing global movement to do away with printed drug information, and FDA recently proposed a rule to promote digital patient medication information. Whyte argues that many patients aren't technologically savvy enough for the transition and that labeling carries intrinsic benefits.

FDA has opened nominations for industry members who want to participate as non-voting members in its Cellular, Tissue, and Gene Therapies Advisory Committee. The committee is called on to advise the agency on important issues, such as the safety and effectiveness of products, and FDA's regulatory oversight.

FDA also finalized its “Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff” which was published in draft form in November 2019. The document outlines the agency's risk-based principles for conducting postmarket surveillance of drugs and biologics.

FDA is holding two public meetings next week. Beginning on 31 January, the agency is holding a two-day workshop with the Reagan-Udall Foundation to discuss conducting clinical trials and developing psychedelic drugs. On 31 January, it will also be holding a public workshop to discuss its thoughts on quality by design (QbD) and risk-based monitoring (RBM) approaches to modernizing clinical trials.

Drugs & Biologics

The Center for Drug Evaluation and Research (CDER) and the Center for Biological Evaluation and Research (CBER) announced they have accepted a new submission for its Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program, which is meant to help develop new drug development tools (DDT) that can be used to evaluate premarket applications. FDA notes that the submission is for an automated depression and anxiety severity measurement tool that uses machine learning to determine clinician-reported outcomes for depression and anxiety based on the Hamilton Depression Rating Scale (HAM-D) and Hamilton Anxiety Rating Scale (HAM-A) scores. The agency also noted it is the first artificial intelligence-based and digital health technology-based project and the first project in neuroscience to be accepted into ISTAND.

CDER also opened the door for up to nine drug manufacturers to participate in its voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program that uses a prototype assessment protocol to evaluate quality management maturity (QMM). The agency said the program is meant to help it assess the usefulness of the protocol.

FDA has sent safety labeling change notification letters to several chimeric antigen receptor (CAR) T cell therapy manufacturers to add boxed warnings to their products labeling about the potential for secondary cancers. In November, the agency posted a safety communication about the potential risk but also noted that the overall benefits of the treatments outweigh their potential risks for their approved uses.

Fierce Pharma reported that FDA's Oncologic Drugs Advisory Committee (ODAC) plans to discuss Johnson & Johnson's cancer drug Carvykti (ciltacabtagene autoleucel). In a securities filing by the company, it noted that the drug to treat multiple myeloma in patients who have received at least one prior line of therapy will be a topic of discussion at an ODAC meeting in the future though no date was given.

Sanofi and Regeneron announced FDA has approved their eosinophilic esophagitis (EoE) drug Dupixent (dupilumab) to treat patients between 1 and 11 years. They noted the drug was reviewed under priority review and is the first and only drug approved in the US for the specific indication.

Reuters reported that three people had to seek medical attention due to dangerously low blood sugar levels last year after taking suspected counterfeit versions of Novo Nordisk's diabetes drug Ozempic (semaglutide). It also reported that at least one person suffered from hypoglycemia last year after being injected with a compound version of the drug according to America's Poison Centers.

FDA published a manual of policies and procedures (MAPP) that are meant to be used by the Office of Pharmaceutical Quality (OPQ), the Office of Compliance, and the Office of Generic Drugs (OGD) when they are assessing requests for reclassification of facility-based major complete response (CR) letter amendments for original abbreviated new drug applications (ANDA) and their prior approval supplements (PASs). The agency noted that the document only applies to requests for major-to-minor reclassifications for CR letters issued on or after the Generic Drug User Fee Amendment (GDUFA III) went into effect in October 2022.

FDA sent an untitled letter to Vitacell Biologics dated 16 January stating the company has been marketing products on its website that it claims are derived from human umbilical cord as stem cell therapy without an approved Biologics License Application (BLA) or an Investigational New Drug (IND) application. The agency has asked the company to address the regulatory violations within 30 days.

FDA also sent an untitled letter to Novartis for making "false or misleading representations about the efficacy" of its breast cancer drug Kisqali (ribociclib) in a TV ad. The agency said the ad overstates the efficacy of the drug when it claims that it “preserves quality of life” and that patients taking the drug are “living well.” The agency has given Novartis 15 days to respond to the letter.

Medtech

The Center for Devices and Radiological Health (CDRH) announced it has elevated its Office of Strategic Partnerships and Technology Innovation (OST) to a super office. The agency said the move will better position it to handle future public health emergencies and supply chain problems. As part of the move, five offices have been established or brought under OST, including the Office of Supply Chain Resilience (OSCR), Digital Health Center of Excellence (DHCoE), Office of Technology and Data Services (OTDS), Office of Readiness and Response (ORR), and Office of Equity and Innovative Development (OEID).

This Week at FDA: New guidance, a new super office, and farewell to Janet Woodcock

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