Article Summary:
The FDA has announced several notable regulatory actions and developments this week. Firstly, the agency’s biologics chief, Vinay Prasad, stated that the FDA will now require randomized controlled trials (RCTs) to support claims about the concurrent administration of vaccines, such as giving COVID-19 and influenza vaccines together. Prasad expressed doubts about the safety and efficacy of this practice without rigorous clinical trials.
Additionally, the FDA will start publishing complete response letters (CRLs) soon after they are issued to drug companies, as part of an effort to promote transparency around the reasons for product rejections. However, some experts have raised concerns about the legal implications of releasing these documents.
The text also discusses the recent clash between Health and Human Services Secretary Robert Kennedy Jr. and lawmakers over his controversial vaccine policies. Kennedy is expected to claim that Tylenol use during pregnancy and low folate levels are likely causes of autism, and that HHS will recommend folate-derived medicines as a treatment.
Furthermore, the state of Florida has announced plans to make vaccine mandates optional for school-aged children and college students, which public health experts worry will contribute to declining vaccination rates.
Lastly, the FDA has created a “Green List” to prevent active pharmaceutical ingredients used in GLP-1 drugs from unverified foreign sources from entering the US, as part of its efforts to address safety concerns related to compounded versions of these blockbuster drugs.
The article also covers other regulatory developments related to rare disease treatments, generic ophthalmic products, and the approval of a new drug for immune thrombocytopenia.