Biden Picks Former F.D.A. Chief to Lead Federal Vaccine Efforts

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

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

He will be Dr. Replace Moncef Slaoui, a researcher and former CEO of a pharmaceutical company who is becoming an advisor to Operation Warp Speed. Dr. Kessler will share primary responsibility for the initiative with General Gustave F. Perna, who will continue to serve as chief operating officer, according to a Biden interim spokesperson. Dr. Kessler’s responsibilities include the manufacture, distribution, and safety and effectiveness of vaccines and therapeutics.

“DR. Kessler became a trusted advisor to the Biden campaign and President-elect Biden at the start of the pandemic and has informed Biden probably 50 or 60 times since March,” said Anita Dunn, co-chair of the transition team. “When employees are asked: “What do the doctors say?” We know that David Kessler is one of the doctors that President-elect Biden has asked us to do. “

Dr. Kessler will join Operation Warp Speed ​​at a critical time. Although the program is widely credited with enabling the development of two highly potent coronavirus vaccines in record time, it has been much less successful in actually delivering the shots to the public – a complex task that involves numerous federal, state and local authorities Splits.

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

At some vaccination sites, long lines of elderly people have lined up for hours waiting for a vaccine. For others, a lack of willing recipients forces vendors to offer the shots to random passers-by before the cans expire.

In late fall, Dr. Kessler told Mr. Biden that Operation Warp Speed ​​was not prepared to get the shots into the arms of the people. The transition team said last week that the president-elect intends to set up vaccination sites in high schools, convention centers and mobile units to target high-risk populations. Details of the plans are expected on Friday.

Dr. In addition to working to accelerate vaccine delivery across the country, Kessler will also focus more on developing therapies. According to transitional officials, he plans to launch an extensive antiviral development program to treat Covid-19. He also plans to build U.S. capabilities to manufacture vaccines against the coronavirus as well as leading known pathogens.

Dr. Kessler is Dr. Anthony Fauci, the nation’s leading infectious disease doctor who became the leading government voice on the coronavirus pandemic. The two worked closely to expedite drug development and approval that changed the course of the AIDS epidemic of the 1990s.

When George Bush made him head of the FDA in 1990, AIDS was raging in the United States. During the tenure of Dr. Kessler issued the FDA new rules to accelerate drug approval. The pharmaceutical industry developed a class of antiviral drugs called protease inhibitors to treat AIDS / HIV, some of which were approved within 40 days.

“Each of these drugs that I took with Tony,” said Dr. Kessler in an interview about Dr. Fauci. “We did it together. We approved more than a dozen antivirals and antibiotics. We expedited approval, but we got it right. “

As commissioner, Dr. Kessler was also known for his fight against the tobacco industry, which until then was considered sacrosanct in American politics.

Under his direction, and with significant help from investigator Jack Mitchell, the FDA proved that the tobacco industry knew for 50 years that nicotine was an addictive substance and that cigarette manufacturers can control the levels of nicotine in their products.

This work formed the basis of the landmark 1998 Framework Settlement Agreement that forced the tobacco industry to pay states an estimated $ 206 billion in damages and to change the way they advertise and sell tobacco products. It also led to the passage of the Family Smoking Prevention and Tobacco Control Act of 2009, which eventually gave the FDA the power to regulate tobacco products.

Dr. Kessler’s other major government focus was improving the American diet. As FDA commissioner, he developed modern nutrition labels that are easy to read and contain basic nutritional information that was previously often left out.

After retiring from the FDA, Dr. Kessler Dean of the Yale School of Medicine, followed by a position as Dean and Vice Chancellor of the San Francisco Medical School of the University of California. After whistling at the university for financial irregularities, he was dismissed as dean, but after an independent examiner concluded he was right, the university apologized and he remained a professor.

In 2018, Dr. Kessler chairman of the board of the Center for Science in the Public Interest, a monitoring group for nutrition and health, which often criticizes the health policy of the federal government.

For several years he was on the board of directors of Immucor, a provider of transfusion and transplant diagnostic products. In 2020 he joined the board of directors of Ellodi Pharmaceuticals, a spin-off from Adare Pharmaceuticals that specializes in gastroenterological drugs.

This week he stepped down from all three boards and is selling his shares in the companies. He said he didn’t own any vaccine or drug company stocks.

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