This Week at FDA: Makary seen as Trump’s top FDA pick, Marks braces for ‘vigorous’ dialogue on vaccines

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, multiple outlets reported that Martin “Marty” Makary, a surgeon at Johns Hopkins Hospital and an outspoken and sometimes contrarian critic of public health measures – including vaccine mandates during the COVID-19 pandemic – is President-elect Donald Trump’s top choice to lead FDA.

Both Reuters and Bloomberg reported that Makary is the leading candidate for FDA Commissioner, citing unnamed sources familiar with the decision-making process, though no formal announcement has been made and the decision is reportedly not final. During the COVID-19 pandemic, Makary criticized FDA for taking too long to review Pfizer and BioNTech’s mRNA COVID-19 vaccine, opposed vaccine mandates for the general public, argued against multiple doses of mRNA COVID-19 vaccines for adolescent boys, and joked about being “an unboosted male” during a podcast in December 2021 with other two other influential doctors.

STAT News reports that Peter Marks, director of the Center for Biologics Evaluation and Research, warned the audience at Jeffries London Healthcare Conference about the dire consequences of falling vaccination rates, which some public health experts fear could worsen under a second Trump administration.

“If you put your hand on a hot oven, you will get burned,” he said, though he added that there will be a “vigorous dialogue” with the incoming administration on vaccines and that he has “to believe that some degree of moderation will prevail.” Marks also apparently hopes to stick around to for those discussions, telling the audience he plans to “stay around as long as I’m considered to be welcome.”

During a joint meeting on Tuesday, FDA’s Drug Safety and Risk Management and Psychopharmacologic Drugs advisory committees said that the risk evaluation and mitigation strategy (REMS) for the schizophrenia drug clozapine is burdensome and advised the agency to remove restrictions on the drug, Medscape reports.

FDA announced that it has reorganized the Office of Digital Transformation within the Office of the Commissioner to “consolidate similar functions and resources across multiple areas and align the organizational structure with federal and industry standards. This will create a more agile organization, improve resource management, enhance customer service, and better align the name of organizational components with current functions.”

Pharma & biotech

On Wednesday, FDA granted accelerated approval to Jazz Pharmaceuticals’ Ziihera (zanidatamab-hrii) for previously treated, unresectable or metastatic HER2+ (IHC 3+) biliary tract cancer based on diagnosis with an FDA-approved test. Alongside the approval, FDA authorized Ventana Medical Systems’ and Roche Diagnostics’ VENTANA PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody as a companion diagnostic for the drug.

Reuters reports that FDA researchers have found the asthma drug montelukast “may be linked to serious mental health problems for some patients,” based on preliminary research findings. Previous reports and research prompted FDA to add a boxed warning to the drug’s label in 2020. The outlet said that FDA does not plan to further update the labeling.

FDA has updated its generic drug activities reports for sections 807 and 805 of the FDA Reauthorization Act of 2017 to reflect metrics for priority review abbreviated new drug applications (ANDAs), those with competitive generic therapy designations, and pending suitability petitions through the fourth quarter of FY 2024.

In a post to FDA’s website, Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni and Theresa Michele, director of CDER’s Office of Nonprescription Drugs, detailed FDA’s actions under the over-the-counter monograph drug user fee program (OMUFA) since its enactment in 2020 and provided an overview of reauthorization activities. The agency hosted a public meeting on Wednesday to gather feedback on the OMUFA II commitment letter and has opened a public docket for comments on the letter and other OMUFA reauthorization recommendations.

Earlier this week, FDA announced the release of 60 new and revised product-specific guidances (PSGs) meant to promote the development of generic drugs. Among the documents are 29 new and 31 revised PSGs, 38 of which target products with no approved generic alternatives and 31 for complex products.

Medtech

This week, FDA said it will pilot a new program to enhanced medical device recall communications for high-risk recalls. “This pilot effort aims to increase transparency and minimize the time between the FDA’s initial awareness of and public communication of potentially high-risk medical device removals or corrections,” said Center for Devices and Radiological Health (CDRH) Director Michelle Tarver. The pilot is set to include cardiovascular, gastrorenal, general hospital, obstetrics and gynecology, and urology devices.

FDA announced it has qualified a new medical device development tool (MDDT), a clinical outcome assessment for would care called WOUND-Q. The agency said the instrument “can measure outcomes important to individuals with nonhealing chronic wounds (lasting three months or longer) for medical device development.” The tool features seven separate scales to assess different wound characteristics and their impact on patients’ quality of life.

AdvaMed touted the introduction of the bipartisan Ensuring Patient Access to Critical Breakthrough Products Act in the Senate this week, following the advancement of similar legislation in the House Ways and Means Committee in June. The lobby group said the bill would expedite reimbursement for breakthrough-designated medical devices by Medicare and urged its passage.

FDA finalized guidances detailing its expectations for 510(k) submissions for orthopedic non-spinal bone plates, screws, and washers, as well as performance criteria for orthopedic non-spinal metallic bone screws and washers under the safety and performance based pathway.

This Week at FDA: Makary seen as Trump’s top FDA pick, Marks braces for ‘vigorous’ dialogue on vaccines

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