How the FDA was shaped by public health crises and patient advocacy,
told against a background of the contentious hearings on the breast
cancer drug Avastin.
Food and Drug Administration approval for COVID-19 vaccines and the
controversial Alzheimer's drug Aduhelm made headlines, but few of us
know much about how the agency does its work. Why is the FDA the
ultimate US authority on a drug's safety and efficacy? In Drugs and the
FDA, 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. It took a series
of tragedies and health crises, as well as patient advocacy, for the
government to take responsibility for ensuring the efficacy and safety
of drugs and medical devices.
Before the FDA existed, drug makers could hawk any potion, claim
treatment of any ailment, and make any promise on a label. But then,
throughout the twentieth century, the government was forced to take
action when 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 all 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 Avastin
hearings, he says, put to the test a century of the FDA's evolution,
demonstrating how its system of checks and balances works--or doesn't
work.
