President-elect Joseph R. Biden Jr. has chosen Dr. David Kessler to help lead Operation Warp Speed, the program to accelerate 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, has been a key adviser to Mr. Biden on Covid-19 policy and is co-chair of the transition team’s Covid-19 task force.
He will replace Dr. Moncef Slaoui, a researcher and former drug company executive, who will become a consultant to Operation Warp Speed. Dr. Kessler will share top responsibilities for the initiative with Gen. Gustave F. Perna, who will continue as chief operating officer, according to a Biden transition spokesman. Dr. Kessler’s responsibilities will cover manufacturing, distribution and the safety and efficacy of vaccines and therapeutics.
“Dr. Kessler became a trusted adviser to the Biden campaign and to President-elect Biden at the beginning of the pandemic, and has probably briefed Biden 50 or 60 times since March,” said Anita Dunn, co-chair of the transition team. “When staff gets asked, ‘What do the doctors say?,’ we know that David Kessler is one of the doctors that President-elect Biden expects us to have consulted.”
Dr. Kessler will join Operation Warp Speed at a critical time. Although the program is widely credited with making possible the development of two highly effective coronavirus vaccines in record time, it has been much less successful at actually delivering the shots to the public — a complex task it shares with numerous federal, state and local authorities.
The Trump administration had vowed to vaccinate 20 million people by the end of 2020, but as of Thursday, just over 11 million inoculations had been given, according to the Centers for Disease Control and Prevention.
At some vaccination sites, long lines of elderly people have queued up for hours waiting for a vaccine; at others, a lack of willing recipients is forcing providers to offer the shots to random passers-by, before the doses expire.
In the late fall, Dr. Kessler warned Mr. Biden that Operation Warp Speed was not prepared for getting the shots into people’s arms. The transition team said last week that the president-elect intended to create vaccination sites in high school gyms, convention centers and mobile units to reach high-risk populations. Details of the plans are expected on Friday.
In addition to working to speed delivery of vaccines throughout the country, Dr. Kessler is expected to increase the emphasis on development of treatments, and he plans to begin a major antiviral development program for treatment of Covid-19, according to transition officials. He also wants to build U.S. capacity for manufacturing vaccines against the coronavirus as well as leading known pathogens.
Dr. Kessler is close to Dr. Anthony Fauci, the nation’s top infectious disease doctor who became the leading governmental voice on the coronavirus pandemic. The two worked closely to speed the development and approval of drugs that changed the course of the AIDS epidemic in the 1990s.
When George Bush appointed him to lead the F.D.A. in 1990, AIDS was raging in the United States. During Dr. Kessler’s tenure, the F.D.A. issued new rules designed to speed drug approval. The pharmaceutical industry developed a class of antiviral drugs to treat AIDS/H.I.V., called protease inhibitors, some of which were approved within 40 days.
“Every one of those drugs I did with Tony,” Dr. Kessler said of Dr. Fauci in an interview. “We did it together. We approved more than a dozen antivirals plus antibiotics. We accelerated the 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 had been considered sacrosanct in American politics.
Under his direction, and with significant help from the investigator Jack Mitchell, the F.D.A. proved that the tobacco industry knew 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 landmark Master Settlement Agreement in 1998, which forced the tobacco industry to pay an estimated $206 billion in damages to the states, and to change the way they advertised and sold tobacco products. It also led to the 2009 passage of the Family Smoking Prevention and Tobacco Control Act, which finally gave the F.D.A. the authority to regulate tobacco products.
Dr. Kessler’s other big focus in government was improving American diets. As F.D.A. commissioner, he developed modern-day nutrition facts labels that are easy to read and include basic nutritional information that was often previously omitted.
After leaving the F.D.A., Dr. Kessler 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 Medical School. After blowing the whistle on financial irregularities at the university, he was dismissed as dean, but after an independent auditor concluded he was correct, the university apologized and he stayed on 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 watchdog group that is often critical of federal health policy.
He has served on the board of Immucor, a provider of transfusion and transplantation diagnostics products, for several years. In 2020, he joined the board of Ellodi Pharmaceuticals, a spinoff from Adare Pharmaceuticals, specializing in gastroenterology-focused drugs.
This week, he resigned from all three boards and is divesting his stock in the businesses. He said he did not own any stock in vaccine-related or pharmaceutical companies.