Indian-American scientist Vinay Prasad is resigning from his position overseeing vaccine and therapy approvals at the Food and Drug Administration’s Centre for Biologics Evaluation and Research. This marks his second departure within a year, following disputes over his decisions to tighten certain regulations. Prasad’s exit was announced by the agency’s head, Marty Makary.
Prasad initially left his role in July, shortly after assuming the directorship, due to backlash from the extreme right over his past support for Democrats. However, he was reinstated in August by Health Secretary Robert F Kennedy Jr, who shared some skepticism of the medical and pharmaceutical industries with Prasad.
Makary praised Prasad’s accomplishments during his tenure, noting that the centre achieved a record number of medication approvals under his leadership. While Prasad relaxed some trial requirements, his specific demands for trials led to conflicts with pharmaceutical companies.
One notable clash involved Moderna, whose flu vaccine application was blocked by Prasad over trial concerns. The pharmaceutical industry, including Moderna, pushed back against Prasad’s decisions, leading Makary to overrule him. Another issue arose when Prasad rejected an application from Dutch company UniQure for a Huntington’s Disease drug.
During his academic career, Prasad criticized certain regulations implemented by the Biden administration amid the COVID pandemic. His vocal opposition to FDA and pharmaceutical industry practices attracted the attention of Kennedy.
