Holes in the Safety Net
The FDA and the FTC
The culture within the FDA should welcome, not censure, differences of opinion
about the impact of science on policymaking. —Richard Horton1
GOVERNMENT rules, regulations, abbreviations, and acronyms make our eyes glaze over faster than reading the phone book. But a couple of federal agencies have a big impact on how medical advances get introduced. Some background is important to understanding why regulatory approval may not be the "Good Housekeeping Seal of Approval" that many imagine it to be.
The Food and Drug Administration (FDA) approves new drugs and devices, as well as assuring that foods and cosmetics are safe.* It monitors more than $1 trillion worth of products, representing nearly a fourth of all consumer spending.3 In the medical arena, the FDA's basic goal is to keep people from selling you snake oil—stuff that's ineffective or harmful. Given budget constraints, an overwhelming number of new products to evaluate, and the onus of being labeled as part of the Big Government
*The section of this chapter dealing with the FDA was published in a slightly different
form in the Journal of the American Board of Family Practice.2 This adaptation is published