This Week at FDA: Makary reportedly on the way out at FDA, new guidance, 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. Multiple outlets reported that FDA Commissioner Marty Makary is being pushed out at FDA, though it is unclear how or when the departure will take place.
On Friday, the Wall Street Journal reported that President Donald Trump has approved a plan to fire Makary. This decision follows a turbulent period for the agency, which has been embroiled in conflicts over vaping, abortion, and drug policies. Top officials in the Trump administration reportedly view Makary as struggling to manage the agency. He has often clashed with health department officials and, at times, the White House. His tenure has also been affected by rapid turnover in FDA’s leadership ranks.
A report by Bloomberg earlier this week delved into the various issues plaguing the agency under Makary’s tenure and suggested that his job may be at risk. Sources at the agency told Bloomberg the agency has been “rocked by staff clashes, leadership turmoil, industry backlash and an embattled leader.” Richard Pazdur, the former director of the center for drugs and long-time agency veteran, quit within a month of taking the role citing “poor communications about personnel moves, top-down decision making and concerns that top officials didn’t understand the regulatory process.”
The Journal reports that Makary is set to become the latest top official dismissed under Health and Human Services (HHS) Secretary Robert Kennedy Jr. This follows the removal of Centers for Disease Control and Prevention Director Susan Monarez last summer and the ousting of HHS Deputy Secretary Jim O’Neill in February.
In other news, FDA announced the launch of Elsa 4.0 this week, which it called a “significant upgrade to the agency’s internal AI tool available to all FDA staff, from scientific reviewers to investigators.” The agency also consolidated over 40 disparate application and submission data sources, systems and portals across all FDA centers into a new platform called HALO (Harmonized AI & Lifecycle Operations for Data) as part of the upgrade, said an agency announcement.
FDA announced a new pilot program this week that allows for one-day inspections of facilities identified as low-risk by AI. Makary discussed the program at the annual Food and Drug Law Institute (FDLI) conference in Washington.
Sanofi has asked FDA to pull its type 1 diabetes drug, teplizumab, out of the Commissioner’s national priority voucher program after CDER director Tracy Beth Høeg opposed a staff decision to approve the drug, according to sources familiar with the dispute, according to a report by STAT. The agency already missed its goal date of 21 April to deliver a decision on the treatment.
FDA officials recently blocked the publication of several studies that supported the safety of widely used vaccines for COVID-19 and shingles, according to a report in the New York Times. This information comes from a spokesman for HHS. The studies were conducted by scientists at the agency in collaboration with data firms that analyzed millions of patient records. They found that serious side effects from these vaccines were very rare.
Drugs and Biologics
This week, FDA released a slew of guidances related to healthcare product development: On Tuesday, FDA published final guidance detailing the chemistry, manufacturing, and controls (CMC) flexibilities it plans to employ to assist sponsors in developing cell and gene products for Biologics License Applications (BLAs).
On Friday, FDA announced a final guidance document regarding the design of post-approval pregnancy safety studies. This guidance is intended to offer sponsors and investigators recommendations for designing studies that evaluate the outcomes for pregnant women exposed to drug and biological products that FDA regulates. This document finalizes a draft guidance that was issued in May 2019. The agency also released final guidance on developing new antibacterial drugs for treating pulmonary tuberculosis (TB) and a final guidance to assist sponsors in developing drugs to treat Clostridioides difficile infection.
FDA has announced its annual Regulatory Education for Industry (REdI) conference, which will focus on innovative regulatory strategies to advance medical products. The meeting will take place from 19-20 May and aims to provide participants with a basic understanding of FDA’s regulatory requirements.
FDA has announced a meeting of its Vaccines and Related Biological Products Advisory Committee on 28 May.
FDA has announced a town hall meeting on 4 June to discuss best practices in best practices in preparing BLA submissions for cell and gene therapy products.
Medical Devices
On Wednesday, FDA’s Center for Devices and Radiological Health (CDRH) released a final guidance on patient-matched guides for orthopedic implants. These guidelines recommend the information that should be included in regulatory submissions for patient-matched guides to orthopedic implants.
FDA is adding neurosurgical patties (product code HBA) to its medical device shortage list. On Wednesday, the agency also announced that the US is experiencing interruptions in the supply of neurosurgical patties, sponges and strip devices due to recent supplier issues and the manufacturing disruption “may require adjustments to the clinical management of patients receiving neurosurgery or microsurgery.”
CDRH has also announced three reclassification decisions: the reclassification of the circulating tumor cell enrichment devices into class II special controls category. The agency has determined that reclassifying these devices into the class II category will “provide a reasonable assurance of safety and effectiveness of the device.” FDA has also reclassified devices that preserve and stabilize microbial nucleic acids in clinical samples to class II and reclassified the corneal storage medium with preservatives including antifungals into class II.
