Try free for 30 days

1 credit a month to use on any title, yours to keep (you’ll use your first credit on this title).
Stream or download thousands of included titles.
Access to exclusive deals and discounts.
$16.45 a month after 30 day trial. Cancel anytime.
Drugs and the FDA cover art

Drugs and the FDA

By: Mikkael A. Sekeres
Narrated by: Mike Lenz
Try for $0.00

$16.45 per month after 30 days. Cancel anytime.

Buy Now for $26.99

Buy Now for $26.99

Pay using voucher balance (if applicable) then card ending in
By confirming your purchase, you agree to Audible's Conditions Of Use and Privacy Notice and authorise Audible to charge your designated credit card or another available credit card on file.

Publisher's Summary

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 United States 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.

©2022 Mikkael A. Sekeres (P)2023 Tantor

What listeners say about Drugs and the FDA

Average Customer Ratings

Reviews - Please select the tabs below to change the source of reviews.

In the spirit of reconciliation, Audible acknowledges the Traditional Custodians of country throughout Australia and their connections to land, sea and community. We pay our respect to their elders past and present and extend that respect to all Aboriginal and Torres Strait Islander peoples today.