This Week: Prasad’s back, FDA considers COVID authorization, MAHA draft report leaked

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, Vinay Prasad returned to FDA, the agency is considering withdrawing its EUA for Pfizer’s COVID-19 vaccine for children under 5 years, and a draft of the second MAHA Commission report has surfaced.

Vinay Prasad, director of the Center for Biologics Evaluation and Research (CBER), has had an eventful few weeks. Over the past month, he has come under heavy criticism from conservatives such as Laura Loomer, a conservative influencer and close advisor to President Donald Trump, and the Wall Street Journal editorial board for being a socialist and anti-business regulator who is trying to hamper the president's agenda from inside the agency.

Under pressure, Prasad resigned from FDA two weeks ago after just three months on the job. Since then, FDA Commissioner Marty Makary stated in interviews that he is actively trying to persuade him to return, and by Monday, Prasad was back as CBER director.

According to Politico, White House Chief of Staff Susie Wiles intervened to return Prasad to FDA. Makary and Health and Human Services (HHS) Secretary Robert Kennedy Jr., pleaded to bring him back and insisted that he was integral to their Make America Health Again (MAHA) movement.

The New York Times reported on the draft version of the much-anticipated second Make America Healthy Again (MAHA) Commission report on children's health in the US. The first report had significant errors, such as fake citations, and had to be updated. The second report was scheduled to be released on Tuesday, but was delayed. According to the draft, the commission isn't proposing any significant changes that could restrict common food practices, such as banning ultra-processed foods and the use of pesticides. However, it does recommend investigating food ingredients and chemical exposures, as well as containing numerous concepts of interest to pharmaceutical and medical device companies. Specifically, the draft report discusses the use of antidepressant and stimulant drugs, childhood vaccination schedules, vaccine injury compensation, and direct-to-consumer advertising, according to the New York Times.

After criticizing Prasad, the Wall Street Journal editorial board this week attacked Makary in an op-ed stating that new drug approvals have slowed down this year under his leadership at FDA. The editorial board argued that FDA regulators are rejecting drugs, such as Replimune’s melanoma drug RP1 (vusolimogene oderparepvac), by falsely raising scientific standards. The op-ed also criticized Makary’s support of Prasad.

According to a report by FedScoop, at least some FDA employees who were fired as part of the Trump administration's reduction-in-force initiative were sent personally identifiable information (PII) of other employees. The employees were sent packages with personnel documents and retirement details, which, in some cases, also included PII such as Social Security numbers.

Over the past several months, HHS has made several controversial decisions limiting the use of COVID-19 vaccines. Now, CNBC reports that FDA is considering revoking authorization of Pfizer's COVID-19 vaccine for children under the age of 5 years, which could leave them without a vaccine option since the Moderna and Novavax vaccines are authorized or approved for limited populations.

A ProPublica investigation found that since 2013, the FDA has allowed medications manufactured at officially banned foreign factories to be imported into the US to prevent drug shortages. Despite setting up guardrails, the report notes that the agency did not regularly test or proactively monitor the products.

FDA announced it will host a virtual workshop with the Duke-Margolis Institute for Health Policy on 10 September to discuss challenges and strategies for expedited chemistry, manufacturing, and controls (CMC) development. Industry and regulators will discuss best practices and lessons learned from FDA's Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program.

FDA and Duke-Margolis have also scheduled a hybrid meeting at the National Press Club in Washington, DC, on 23 September to discuss using real-world evidence (RWE) in regulatory submissions. The meeting is part of the FDA's requirement under the Prescription Drug User Fee Amendment (PDUFA VII) to convene a public workshop to discuss RWE examples and lessons learned from case studies using RWE in product submissions.

Drugs & Biologics

HHS announced that it is reviving the Task Force on Safer Childhood Vaccines, which was disbanded in 1998. Jay Bhattacharya, director of the National Institutes of Health (NIH), said the move will allow the government to improve oversight of childhood vaccines. Anti-vax activists have long called for the task force's reestablishment. According to experts who spoke to the Washington Post, the panel could be used to undermine public trust in vaccines.

FDA and the Center for Research on Complex Generics (CRCG) announced a two-day hybrid workshop to discuss measuring particle size distribution used to develop quality control methods for bioequivalence in complex generic drug products. The presenters will offer hands-on experience and demonstrate techniques to perform particle size measurements.

Medtech

Draeger is pulling certain filters for its SafeStar and TwinStar breathing systems off the market as part of a class I recall due to reports that they may give misleading carbon dioxide (CO₂) readings. The filters are used during anesthesia and mechanical ventilation to prevent microbial contamination, and the faulty readings could result in adverse events, including death.

FDA issued an early alert for Baxter's Novum IQ Large Volume Pumps (LVP) and Novum IQ Syringe Pumps (SP) infusion pumps after the company issued an urgent medical device correction letter stating software malfunction may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only). The company said users should consider using an alternate pump, if possible, but can continue to use the pumps as long as they follow its instructions.

This Week: Prasad’s back, FDA considers COVID authorization, MAHA draft report leaked

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