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The modern pharmaceutical industry was built one law at a time, usually after a disaster. Sulfanilamide killed more than a hundred children before pre-market safety review existed. Thalidomide deformed thousands of babies before the FDA required proof of efficacy. Each crisis added a piece of the regulatory machinery we now take for granted.
First federal law banning misbranded or adulterated drugs. The "patent medicine" era — laudanum, cocaine tonics, sold by mail order — formally begins to end.
Passes after the sulfanilamide elixir disaster kills 107 people, many of them children. Requires drug makers to prove safety to the FDA before marketing — the birth of pre-market review.
Creates the modern distinction between "over-the-counter" and "prescription only." Until this point, what required a doctor's slip was decided mostly by pharmacists.
After thalidomide causes thousands of severe birth defects in Europe, Congress requires manufacturers to prove drugs are effective — not just safe. Establishes the modern randomized-controlled-trial standard.
Creates the abbreviated new drug application (ANDA): generics can rely on the brand's safety data. In exchange, brands get patent-term restoration. The deal that made the modern generics industry.
Drugmakers start paying the FDA directly for application reviews. Approval times drop from ~30 months to ~12. Critics argue it makes the regulator dependent on its regulated industry.
FDA clarifies that broadcast direct-to-consumer ads only need to mention "major" risks. The U.S. becomes one of just two countries (with New Zealand) allowing prescription-drug ads on TV.
Adds outpatient prescription coverage for the 65+. The bill explicitly forbids Medicare — the largest U.S. drug buyer — from negotiating prices with manufacturers. Stays in force for 19 years.
Establishes the biosimilar pathway — a generics-style route for biologics. The first biosimilar (Zarxio) launches in the U.S. in 2015.
In FTC v. Actavis the Supreme Court rules that brand-to-generic patent settlements can be antitrust violations — clamping down on a tactic that had delayed generics on dozens of blockbusters.
Turing Pharma raises the price of a 60-year-old toxoplasmosis drug from $13.50 to $750 a pill overnight. Generic-drug price gouging becomes a bipartisan congressional cause.
The Inflation Reduction Act ends the Part D non-negotiation rule. Medicare names 10 high-spend drugs for the first round; negotiated prices take effect January 2026.
Semaglutide (Ozempic / Wegovy) and tirzepatide (Mounjaro / Zepbound) become the fastest-growing drug class ever measured. By 2025, GLP-1 sales pass $50B globally, with U.S. shortages persisting for over two years.
A few orienting numbers — what Americans spend, how often they take medicine, how often a new drug actually gets approved, what the industry says it costs to make one.