Seven Former FDA Commissioners: The FDA Should Be An Independent Federal Agency

The FDA as a public health agency.

n engl j med 360;24 nejm.org june 11, 2009 2493 Act. The act sought to prevent the “manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors.” The office initially charged with this responsibility was the Bureau of Chemistry of the Department of Agriculture. Since that time, the bureau has grown into the Food and Drug Adm...

FDA Reform and the European Medicines Evaluation Agency

Former FDA commissioner pleads guilty to two charges.

The FDA should test the safety of ECT machines ∗

Electroconvulsive therapy (ECT) and the machines that deliver it have never been tested for safety and efficacy in order to receive approval from the FDA. The American Psychiatric Association and ECT advocates protested when the FDA took steps to classify the machines as posing “an unreasonable risk of illness or injury”, which would have required their testing before approval. Without requirin...

23andMe and the FDA.

n engl j med 370;11 nejm.org march 13, 2014 985 of things about your health,” including that you “might have an increased risk of heart disease, arthritis, gallstones, [or] hemochromatosis” (www.ispot.tv/ad/7qoF/ 23-and-me). It was the centerpiece of the company’s campaign to sign up 1 million consumers. On November 22, the Food and Drug Administration (FDA) sent 23andMe a warning letter orderi...