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May 7, 2025 | Washington, D.C.
The US Food and Drug Administration (FDA) has chosen Dr. Vinay Prasad, a cancer and blood specialist, to lead its Center for Biologics Evaluation and Research. This is the department in charge of vaccines and other biological medicines.
Dr. Prasad is a professor at the University of California, San Francisco. During the COVID-19 pandemic, he often criticized the government’s response, especially vaccine rules. He will take over from Dr. Peter Marks, who led the division for 13 years and played a big role in Operation Warp Speed, the program that quickly developed COVID-19 vaccines and treatments.
Dr. Marks resigned in March. In his resignation letter, he blamed US Health and Human Services Secretary Robert F. Kennedy Jr. for spreading false information about vaccines. He wrote that the Secretary did not want truth and transparency but only support for his false claims.
Dr. Prasad has often criticized Operation Warp Speed and Dr. Marks’ leadership. He shared his views on his blog and social media platform X (formerly Twitter). He was supported by Dr. Marty Makary, who is now the FDA Commissioner. Dr. Makary praised Prasad for questioning policies like school closures, mask use, and booster shots.
In an email to FDA staff, Dr. Makary said Dr. Prasad has a strong medical background and has done a lot of research in cancer treatment.
Now, the FDA plans to make future vaccines go through placebo studies (where some people get the vaccine and others get a fake one) before approval. Public health leaders are also thinking about changing the Covid-19 vaccine advice for children. Dr. Prasad has said that young children don’t need the shots as much because they have a lower risk of severe illness.
After the announcement, biotech company stocks dropped more than 5%. Experts say this is because Dr. Prasad is seen as someone who challenges the system. He has also questioned how the FDA approves some drugs quickly with limited testing.
One company, Sarepta Therapeutics, saw its stock drop almost 25%. Dr. Prasad had criticized the FDA’s approval of Sarepta’s gene therapy drug, Elevidys, saying there wasn’t enough proof it worked, even though it costs a lot and could have side effects.
As the new head of the biologics division, Dr. Prasad may bring stricter rules for companies making gene therapies. Earlier this year, he wrote that the FDA needs to speed up only the approval of effective gene therapies—not just any treatment with weak evidence.
On the day of his appointment, biotech stocks performed almost as poorly as the day President Trump announced that Robert F. Kennedy Jr. would lead the Health and Human Services department, according to a report from the Mizuho Group.
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