Drugs

House Dems Seek Answers on FDA Vaccine Memo

Top House Democrats are pressing FDA for documents and explanations after revelations that a senior FDA official circulated new vaccine development guidelines in an internal email (see earlier story) that the lawmakers say contained misinformation about Covid-19 vaccines.

In a 12/5 letter sent FDA commissioner Marty Makary, Energy and Commerce Committee Ranking Member Frank Pallone Jr. (D-NJ), Health Subcommittee Ranking Member Diana DeGette (D-CO), and Oversight and Investigations Subcommittee Ranking Member Yvette Clarke (D-NY) raised alarms over a memo written by CBER director Vinay Prasad that asserted “at least 10 children have died after and because of receiving COVID-19 vaccination,” a claim they said lacks scientific support, was not sourced to peer-reviewed data, and was contradicted by Prasad’s own admission in the memo that the deaths were only “possible.”

“There is no credible scientific basis for Dr. Prasad’s claims linking COVID-19 vaccines to children’s deaths, which you yourself parroted the following day in an interview,” the lawmakers wrote to Makary. “It is appalling that your leadership would circulate misleading statements that are known to be scientifically overstated.”

The memo, they said, amounted to Prasad “unilaterally ordering new guidelines for vaccine development” without evidence and without following established regulatory procedures. They accused the agency’s leadership of promoting an “extreme, anti-vaccine, partisan agenda.”

Democrats warned that the proposed changes would make it harder for vaccines to win approval under a regulatory system they credited with saving lives for decades. “FDA has yet to provide meaningful data to prove these changes are necessary,” they wrote.

The committee leaders gave the agency until December 19 to provide records supporting Prasad’s claims, including any data suggesting vaccine-related deaths in children, the legal authority for issuing new vaccine policy via email, evidence that current vaccine safety rules are inadequate, and a list of HHS personnel involved in drafting the proposed changes.

“Dr. Prasad’s memo represents a dangerous trend in the agency’s politicization of science under your leadership,” the lawmakers concluded.

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome