President-elect Joseph R. Biden Jr. chose Dr. David Kessler to help lead Operation Warp Speed, the program to accelerate the development of Covid-19 vaccines and treatments, according to transition officials.
Dr. Kessler, a pediatrician and lawyer who headed the Food and Drug Administration during the presidencies of George Bush and Bill Clinton, was one of Biden’s top advisers on Covid-19 policy and is co-chair of the Covid transition team – 19 task force.
He will replace Dr. Moncef Slaoui, a researcher and former executive of a pharmaceutical company, who will become a consultant for Operation Warp Speed. Dr. Kessler will share the main responsibilities for the initiative with General Gustave F. Perna, who will continue as director of operations, according to a spokesman for the Biden transition. Dr. Kessler’s responsibilities will cover the manufacture, distribution and the safety and efficacy of vaccines and therapies.
“Dr. Kessler became a trusted advisor to the Biden campaign and President-elect Biden at the start of the pandemic, and has probably informed Biden 50 or 60 times since March, ”said Anita Dunn, co-chair of the transition team. “When the team is asked, ‘What do the doctors say?’, We know that David Kessler is one of the doctors that President-elect Biden expects us to see.”
Dr. Kessler will join Operation Warp Speed at a critical time. Although the program is widely credited for making it possible to develop two highly effective coronavirus vaccines in record time, it has been far less successful in providing the vaccines to the public – a complex task that it shares with several federal, state and local authorities.
The Trump administration has promised to vaccinate 20 million people by the end of 2020, but as of Thursday, just over 11 million vaccines have been given, according to the Centers for Disease Control and Prevention.
In some vaccination sites, long lines of elderly people spend hours in line waiting for the vaccine; in others, the lack of willing containers is forcing providers to offer doses to random passersby before doses expire.
In late autumn, Dr. Kessler warned Biden that Operation Warp Speed was not prepared to place the shots in people’s arms. The transition team said last week that the president-elect intended to create vaccination sites in high schools, convention centers and mobile units to target high-risk populations. The details of the plans are expected on Friday.
In addition to working to accelerate vaccine delivery across the country, Dr. Kessler is expected to increase the emphasis on treatment development and plans to start a major antiviral development program for the treatment of Covid-19, according to officials transition. He also wants to increase the capacity of the United States to manufacture vaccines against coronavirus, as well as the main known pathogens.
Dr. Kessler is close to Dr. Anthony Fauci, the country’s leading infectious physician who has become the leading governmental voice in the coronavirus pandemic. The two worked 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 to head the FDA in 1990, AIDS was rampant in the United States. During Dr. Kessler’s term, the FDA issued new rules designed to accelerate drug approval. The pharmaceutical industry has developed a class of antiviral drugs to treat AIDS / HIV, called protease inhibitors, some of which have been approved in 40 days.
“Each of these drugs I used with Tony,” said Kessler about Fauci in an interview. “We did it together. We have approved more than a dozen antivirals and antibiotics. We accelerated approval, but we did it the right way. “
As commissioner, Dr. Kessler was also known for his battle against the tobacco industry, which until then was considered sacrosanct in American politics.
Under his direction, and with the significant help of 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.
That work set the stage for the 1998 Master Settlement Agreement framework, which forced the tobacco industry to pay about $ 206 billion in damages to states and to change the way they advertise and sell tobacco products. It also led to the passage of the Tobacco Prevention and Tobacco Control Act in 2009, which finally gave the FDA the authority to regulate tobacco products.
Dr. Kessler’s other major focus on government was to improve American diets. As an FDA commissioner, he developed labels with modern nutritional information that are easy to read and include basic nutritional information that used to be omitted.
After leaving the FDA, Dr. Kessler served as dean at the Yale School of Medicine, followed by a stint as dean and vice dean at the University of California, San Francisco Medical School. After reporting financial irregularities at the university, he was dismissed from the dean, but after an independent auditor concluded that he was right, the university apologized and he continued as a professor.
In 2018, Dr. Kessler became chairman of the board of the Center for Science in the Public Interest, a food and health surveillance group that often criticizes federal health policies.
He served on the board of Immucor, a supplier of products for diagnosis of transfusion and transplantation, for several years. In 2020, he joined the board of Ellodi Pharmaceuticals, a spinoff of Adare Pharmaceuticals, specializing in drugs focused on gastroenterology.
This week, he resigned from all three boards and is scrapping his actions in business. He said he had no shares in pharmaceutical or vaccine-related companies.