Controversies surrounding the FDA's role in regulating drugs and food in the United States
TLDR The FDA has faced criticism for its lack of consistency and use of good science in approving drugs, as well as its failure to regulate the livestock industry and pulling public notices that highlighted the dangers of certain drugs. However, some argue that the FDA's nimbleness is necessary for drugs that treat obscure diseases.
Timestamped Summary
00:00
The podcast episode titled "Does the FDA Protect Americans?" from "Stuff You Should Know" delves into the controversy surrounding the FDA and its role in regulating drugs and food in the United States.
05:30
In 1906, Congress passed the Food and Drugs Act, also known as the Wiley Act, which prohibited the trade of mislabeled and contaminated food, beverages, and medicines across state lines.
10:37
The federal government has taken more and more power from the states over time, and the Wiley Act established standards for purity in food and created the Poison Squad, a group of volunteers who ate poison to test out preservatives and additives in food.
15:30
The FDA evolved from other agencies and went through name changes and reorganizations before becoming the FDA in 1930, and they are now under the purview of the Health and Human Services.
20:51
In 1982, a series of deaths occurred in the Chicago area after people consumed Tylenol laced with cyanide, leading to Johnson & Johnson issuing a national media alert and eventually prompting the FDA to make tamper-resistant packaging mandatory.
26:20
The FDA regulates a wide range of products, with estimates suggesting that 20 cents out of every dollar consumers spend is on a product that falls under FDA regulation, and they also offer guidance on how regulations should be carried out.
32:10
The FDA has been criticized for its lack of consistency and use of good science in approving drugs, but some argue that this nimbleness is necessary for drugs that treat obscure diseases.
37:26
The FDA is often caught in a difficult position of either being accused of moving too slowly and letting people die or moving too quickly and not prioritizing safety.
42:38
A Harvard paper argues that 90% of new drugs approved by the FDA over the past 30 years are no more effective than existing drugs, and one in five approved drugs end up causing serious harm.
48:15
The FDA has been criticized for not taking action to regulate the livestock industry and for pulling public notices that highlighted the dangers of certain drugs, as well as rejecting a million signatures for GMO labeling.
53:38
The FDA's Kefauver-Harris amendments in 1962 expanded its scope of duties, including regulating drug advertising, requiring drug makers to demonstrate both safety and effectiveness, and controlling the marketing of generic drugs.
59:06
The FDA sometimes fails to prioritize public safety, despite having protocols and standards in place.
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