New Title: Drugs and the FDA: Safety, Efficacy, and Public Trust

The U.S. Food and Drug Administration (FDA) is the ultimate authority in the country when it comes to the safety and efficacy of drugs. This regulatory agency has earned the trust of the public through its diligent work, which has been shaped by a series of tragedies and health crises, as well as patient advocacy. Mikkael Sekeres, a leading oncologist and former chair of the FDA's cancer drug advisory committee, tells the story of how the FDA became the most trusted regulatory agency in the world in his book "Drugs and the FDA."

Before the FDA existed, drug manufacturers could freely market any potion, claim it could treat any ailment, and make any promise on a label. However, throughout the twentieth century, the government was forced to take action when various health crises occurred. Children were poisoned by contaminated diphtheria and smallpox vaccines, an early antibiotic contained antifreeze, a drug prescribed for morning sickness in pregnancy caused babies to be born disfigured, and access to AIDS drugs was limited to a few clinical trials while thousands died.

Sekeres describes these events against the backdrop of the contentious 2011 hearings on the breast cancer drug Avastin, in which he participated as a panel member. The FDA's approval of COVID-19 vaccines and the controversial Alzheimer's drug Aduhelm have recently made headlines, but few people understand the agency's inner workings.

The FDA's role is to ensure the safety and efficacy of drugs and medical devices, a responsibility that the government was forced to assume due to a series of tragedies and health crises. By setting strict standards and protocols, the FDA has become the most trusted regulatory agency in the world, protecting the public from potential harm and ensuring that only safe and effective treatments are made available.

The book "Drugs and the FDA" by Mikkael Sekeres provides a comprehensive look at the history and evolution of the FDA, shedding light on the important work this agency does to safeguard the health and well-being of the American people.

product information: