Article Summary:
This week in FDA news, there was controversy around Vinay Prasad, the director of the Center for Biologics Evaluation and Research (CBER). Prasad had come under criticism from conservatives for his views, leading him to resign after just 3 months. However, FDA Commissioner Marty Makary and HHS Secretary Robert Kennedy Jr. worked to bring Prasad back, with White House intervention.
The draft of the second Make America Healthy Again (MAHA) Commission report on children’s health was also released. While it does not propose major food restrictions, it discusses topics of interest to pharmaceutical and medical device companies, such as the use of antidepressants, vaccination schedules, and direct-to-consumer advertising.
The FDA is also considering revoking the emergency use authorization for Pfizer’s COVID-19 vaccine for children under 5, potentially leaving them without a vaccine option. Additionally, a ProPublica investigation found the FDA has allowed medications from banned foreign factories to be imported to prevent shortages, without regularly testing or monitoring them.
The FDA announced upcoming workshops to discuss expedited chemistry, manufacturing, and controls development, as well as the use of real-world evidence in regulatory submissions. The HHS also announced it is reviving the Task Force on Safer Childhood Vaccines, which some experts fear could undermine public trust. Finally, there were recalls of certain medical device filters and infusion pumps due to safety issues.
Overall, the text highlights ongoing debates, regulatory actions, and safety concerns across the drug, vaccine, and medical device landscape.
Article Excerpt:
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.