Drugs 📍

The generic drug boom began in the mid-1980s, when pharmaceutical giants such as Pfizer dominated the market. In response to rising costs and complaints over the influence of "big Pharma," Congress unanimously passed the Hatch-Waxman Act in 1984, which created a new regulatory track for generic drugs. As long as generic manufacturers could prove their drugs were bioequivalent to brand-name drugs, meaning they acted similarly in the body, they could get approved. It was a boon for generic drugmakers, and in principle for the American public, allowing market competition to yield less expensive but equivalent drugs. Bottle of Lies Bottle of Lies The Inside Story of the Generic Drug Boom by Katherine Eban Hardcover, 482 pages purchase But according to Eban, parts of the law incentivized speed over quality. Its "first-to-file" rule granted whichever company filed its FDA application first exclusive rights to sell its version of the generic drug for six months, at near brand-level prices, before competitors could enter the market. According to Eban's reporting, this created a Wild West environment, where being first mattered more than getting it right.