Biden selects former FDA chief to lead federal vaccine efforts

Elected President Joseph R. Biden Jr. has selected Dr. David Kessler to help lead Operation Warp Speed, the program to accelerate the development of Covid-19 vaccines and treatments, according to transitional officials.

Dr. Kessler, a pediatrician and attorney who headed the Food and Drug Administration during the presidency of George Bush and Bill Clinton, was a key adviser to Mr. Biden on the Covid-19 policy and is co-chair of the Covid- of the transition team. 19 task force.

He replaces Dr Moncef Slaoui, a researcher and former CEO of the drug company, who will become a consultant for Operation Warp Speed. Dr. Kessler will share the greatest responsibilities for the initiative with Genl. Gustave F. Perna, who will continue as chief operating officer, according to a Biden transition spokesman. Dr. Kessler’s responsibilities will cover the manufacture, distribution and safety and efficacy of vaccines and therapies.

“At the beginning of the pandemic, Dr. Kessler became a trusted adviser to the Biden campaign and to President-elect Biden, and has probably informed Biden 50 or 60 times since March,” said Anita Dunn, co-chair of the transition team. “When staff are asked, ‘What do the doctors say?’, we know that David Kessler is one of the doctors President Biden prefers to consult with us.”

Dr. Kessler will join Operation Warp Speed ​​at critical time. Although the program widely acknowledges that the development of two very effective coronavirus vaccines has been made possible in record time, it has been far less successful in actually delivering the shots to the public – a complex task that it does with numerous federal, state and local authorities share.

The Trump administration has promised to vaccinate 20 million people by the end of 2020, but as of Thursday, just over 11 million vaccinations have been given, according to the Centers for Disease Control and Prevention.

On some vaccination sites, long queues of elderly people stood in line for hours waiting for a vaccine; in others, a lack of willing recipients forces providers to offer the shots to random passers-by before the doses expire.

In the late autumn, dr. Kessler mnr. Biden warned that Operation Warp Speed ​​was not prepared to get the shots into people’s arms. The transition team said last week that the president-elect is planning to create vaccination rooms in high school gyms, conference centers and mobile units to reach high-risk populations. Details of the plans are expected Friday.

In addition to the fact that dr. Kessler is working to speed up the delivery of vaccines across the country, he is expected to increase the emphasis on the development of treatments, and according to the transitional officials, he plans to start a major antiviral development program for the treatment of Covid-19. He also wants to build US capacity for the production of vaccines against the coronavirus as well as known pathogens.

Dr. Kessler is close to Dr. Anthony Fauci, the country’s leading doctor on infectious diseases, who has become the leading voice of the government on the coronavirus pandemic. The two worked closely together to accelerate the development and approval of drugs that changed the course of the AIDS epidemic in the 1990s.

When George Bush appointed him FDA leader in 1990, AIDS raged in the United States. During the tenure of Dr. Kessler has issued the FDA new rules to expedite drug approval. The pharmaceutical industry has developed a class of antiviral drugs for the treatment of AIDS / HIV, called protease inhibitors, some of which have been approved within 40 days.

“Each of those drugs I did with Tony,” said Dr. Kessler in an interview about dr. Fauci said. “We did it together. We have approved more than a dozen antiviral drugs plus antibiotics. We accelerated the approval, but we did it the right way. ”

As commissioner, Dr. Kessler is also known for his fight against the tobacco industry, which until then had been considered sacred in American politics.

Under his leadership, and with significant help from investigator Jack Mitchell, the FDA proved that the tobacco industry had known for 50 years that nicotine was an addictive drug and that cigarette companies could control the levels of nicotine in their products.

This work laid the foundation for the special Master Settlement Agreement in 1998, which forced the tobacco industry to pay an estimated $ 206 billion in damages to the states and change the way they advertise and sell tobacco products. It also led to the adoption of the Family Smoke Prevention and Tobacco Control Act in 2009, which eventually gave the FDA the power to regulate tobacco products.

Dr. Kessler’s other major focus in government was improving American diets. As an FDA commissioner, he has developed modern labels on nutrition facts that are easy to read and contain basic nutrition information that has often been omitted before.

After leaving the FDA, he served as dean of the Yale School of Medicine, followed by a stint as dean and vice chancellor of the University of California, San Francisco. After whistling about financial irregularities at the university, he was fired as dean, but after an independent auditor concluded that he was correct, the university apologized and he continued as professor.

In 2018, dr. Kessler chairs the board of the Center for Science in the Public Interest, a watchdog group for food and health that is often critical of federal health policy.

He has served on the board of Immucor, a provider of transfusion and transplant diagnostic products, for several years. In 2020, he joined the board of Ellodi Pharmaceuticals, a spinoff of Adare Pharmaceuticals, specializing in gastroenterology-focused medicine.

He resigned from all three boards this week and sold his shares in the company. He said he does not own any shares in vaccine-related or pharmaceutical companies.

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