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RFK Jr.’s Vaccine Group to Revisit Childhood Shots, Hepatitis B
The U.S. Centers for Disease Control and Prevention’s key vaccine panel will reconvene in December to again weigh changes to the long-standing childhood immunization schedule.
The Advisory Committee on Immunization Practices, or ACIP, will meet on Dec. 4 and 5, according to a Federal Register notice posted on Wednesday.
The panel will discuss vaccine safety, the childhood and adolescent shot schedule and the hepatitis B vaccine — an issue it previously debated and delayed for further study.
FDA Names Longtime Oncology Chief Richard Pazdur as New CDER Director
In a surprise move, the U.S. Food and Drug Administration (FDA) has named the longtime leader of its oncology department, Richard Pazdur, M.D., as the new director of the Center for Drug Evaluation and Research, which oversees most prescription drugs. The U.S. Department of Health and Human Services announced the appointment Nov. 11, with FDA Commissioner Marty Makary, M.D., calling Pazdur a “renowned regulatory innovator.”
Pazdur takes over from George Tidmarsh, M.D., Ph.D., who resigned from the agency about a week ago amid an internal investigation into alleged misuse of his regulatory authority to act on a personal vendetta.
Pazdur, a 26-year veteran of the FDA, is a tall figure at the agency who has had a profound influence on cancer drug development and reviews. He was the founding director of the FDA’s Oncology Center of Excellence, which was established in 2017. He’s one of only two center leaders to have remained in service at the FDA after the agency’s significant leadership shakeup under the Trump administration.
With a Word, RFK Jr. Triggered $40B Takeover of Tylenol
Last year, Kenvue seemed to be in the clear over claims its popular Tylenol pain medicine caused autism. A federal judge in New York had dismissed thousands of lawsuits after ruling the evidence of plaintiff experts was unreliable. Kenvue shares rose 30% to more than $24 a share, giving the consumer-products company its highest market value since it was spun out of Johnson & Johnson in 2023.
Then came Robert F. Kennedy Jr., a former trial lawyer now in position to sound an alarm on various consumer products. In September of this year, the Health and Human Services secretary announced the Trump administration was taking “bold new actions” to combat childhood autism.
Those actions included a U.S. Food and Drug Administration (FDA) investigation into a possible connection between acetaminophen use during pregnancy and autism. The FDA said it was starting the process for a label change even as it acknowledged there was no evidence of a causal relationship and acetaminophen remains the only over-the-counter drug approved for treating fevers during pregnancy. Aspirin and ibuprofen are known to be unsafe in pregnancy, as are fevers themselves.
Wearables Could See HIPAA-Style Regulation
Despite voicing some uncertainty about Robert F. Kennedy Jr., Sen. Bill Cassidy (R-La.) wants to regulate one of the Health secretary’s favored components of his Make America Healthy Again agenda to combat chronic disease: wearable health devices.
What’s new: Cassidy, chair of the Senate Health, Education, Labor and Pensions Committee, wants to safeguard health data collected by wearables and health apps, which he says are “helpful tools, but present new privacy concerns that didn’t exist when it was just a patient and a doctor in an exam room.”
Wearable devices — such as smartwatches, rings and fitness trackers — monitor health and exercise metrics including step count, sleep quality and heart rate.
Covid-Era Rules for Addiction Medication, Ritalin Are Extended Again
The Trump administration appears poised to extend a temporary, COVID-19-era rule allowing health providers to prescribe certain controlled substances, like ADHD medications and treatments for opioid addiction, via telemedicine. Under the current rules, providers can initiate prescriptions for drugs like Ritalin or Adderall for ADHD, or buprenorphine for opioid use disorder, without first examining the patient in-person.
The extension would mark the fourth time that the federal government has re-upped the flexibilities, enacted by the Drug Enforcement Administration during March 2020 as the COVID-19 pandemic accelerated, without reaching a permanent decision on how telemedicine prescribing of controlled substances will be regulated.
A posting on a White House budget website, titled “Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications,” signals that the Trump administration has conceded the regulatory limbo will last at least one more year.
