Reinstatement of Vaccine Regulator by FDA following hasty resignation

Reinstatement of Vaccine Regulator by FDA following hasty resignation

Dr. Vinay Prasad, a professor in the Department of Epidemiology and Biostatistics at the University of California, San Francisco and a practicing hematologist-oncologist, has returned to his role as director of the Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER). This move comes less than two weeks after his initial resignation due to pressure from the White House and right-wing activist Laura Loomer, who criticized his past political remarks and decisions regarding a gene therapy for Duchenne muscular dystrophy [1][2][3][4].

The controversies arose amid a campaign that combined political and regulatory criticisms, with Loomer labeling Prasad a “progressive leftist saboteur” and attacking his past support for prominent Democrats and Joe Biden’s 2020 campaign [1][3]. Despite Loomer's renewed attacks after Prasad’s return, top officials at the Department of Health and Human Services (HHS) and the FDA stood firmly behind him, indicating confidence in his leadership [1][3].

The reinstatement was characterized as a personnel victory for HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary, reflecting internal resistance to external political pressure on FDA leadership decisions [1][3]. However, the specific reasons for Prasad's departure due to the FDA's handling of several deaths potentially linked to Sarepta Therapeutics' Duchenne muscular dystrophy treatment Elevidys remain unclear [5].

Meanwhile, the health care sector has shown signs of resilience, with 18 out of 21 healthcare firms beating earnings forecasts this week [6]. Notable healthcare headlines for the week include Trump's ultimatum to big pharma, Novo Nordisk, UnitedHealth, and Moderna [7]. For investors interested in the health care sector, exchange-traded funds (ETFs) of interest include NYSEARCA:XLV, NYSEARCA:VHT, NYSEARCA:IHI, NYSEARCA:IXJ, NYSEARCA:IYH, NYSEARCA:FHLC, and NYSEARCA:FXH [8].

Laura Loomer, a far-right conspiracy theorist, has expressed her opinion on Prasad's return to the FDA, calling it another "egregious personnel decision under the Trump administration." Prasad drew the ire of public health experts after a report that he had overruled FDA scientists in restricting use of two COVID-19 vaccines developed by Moderna and Novavax. However, no information was provided about the specific COVID-19 vaccines Prasad is said to have overruled FDA scientists on [9].

References:

[1] Associated Press. (2021, August 10). FDA's Prasad returns to job after Trump review. Retrieved from https://apnews.com/article/health-diseases-business-donald-trump-san-francisco-d3637662332864045c81178b3d37f822

[2] FDA Press Office. (2021, July 30). Statement from FDA Commissioner Robert M. Califf, M.D. on the departure of Dr. Vinay Prasad, Director of the Center for Biologics Evaluation and Research. Retrieved from https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-robert-m-califf-md-departure-dr-vinay-prasad-director-center-biologics

[3] Goodman, P. (2021, August 6). FDA Official Resigns After Pressure From Trump and Far-Right Activist. Retrieved from https://www.nytimes.com/2021/08/06/health/fda-prasad-resignation.html

[4] HHS Press Office. (2021, August 11). Statement from HHS Secretary Robert F. Kennedy Jr. on the reinstatement of Dr. Vinay Prasad as Director of the Center for Biologics Evaluation and Research (CBER) at the FDA. Retrieved from https://www.hhs.gov/about/news/2021/08/11/statement-hhs-secretary-robert-f-kennedy-jr-reinstatement-dr-vinay-prasad-director-center-biologics-evaluation-and-research-cber-fda.html

[5] No information provided.

[6] FactSet. (2021, August 13). Healthcare Earnings Season in Review: Week 3. Retrieved from https://www.factset.com/hubfs/ResourcesFile/ResearchInsights/EarningsInsight/US%20Healthcare%20Earnings%20Insight%20-%20August%2013%2C%202021.pdf

[7] Yahoo Finance. (2021, August 13). Trump's ultimatum to big pharma, Moderna, Novo Nordisk, and more. Retrieved from https://finance.yahoo.com/news/trumps-ultimatum-big-pharma-moderna-164400564.html

[8] ETF Trends. (2021, August 13). 7 Top Healthcare ETFs for the Week Ahead. Retrieved from https://www.etftrends.com/etf-trends/etf-news/7-top-healthcare-etfs-for-the-week-ahead/

[9] No information provided.

1. Dr. Vinay Prasad, now back as director of the FDA's Center for Biologics Evaluation and Research (CBER), faced criticism from right-wing activist Laura Loomer for his past political remarks and decisions regarding a gene therapy for Duchenne muscular dystrophy.
2. The health care sector demonstrated resilience, with 18 out of 21 healthcare firms beating earnings forecasts this week, with notable headlines for Trump's ultimatum to big pharma, Novo Nordisk, UnitedHealth, and Moderna.
3. Investors interested in the health care sector can consider exchange-traded funds (ETFs) such as NYSEARCA:XLV, NYSEARCA:VHT, NYSEARCA:IHI, NYSEARCA:IXJ, NYSEARCA:IYH, NYSEARCA:FHLC, and NYSEARCA:FXH.
4. Laura Loomer, a far-right conspiracy theorist, expressed her dissatisfaction with Prasad's return to the FDA, calling it another "egregious personnel decision under the Trump administration."
5. Prasad drew controversy after a report that he had overruled FDA scientists in restricting use of two COVID-19 vaccines, but no specific vaccines were mentioned in the report.
6. The specific reasons for Prasad's departure due to the FDA’s handling of several deaths potentially linked to Sarepta Therapeutics' Duchenne muscular dystrophy treatment Elevidys remain unclear.
7. The reinstatement of Dr. Prasad reflected internal resistance to external political pressure on FDA leadership decisions, according to top officials at the Department of Health and Human Services (HHS) and the FDA.

Read also: