Abstract

The US Food and Drug Administration had approved 47 new molecular entities by early December, on pace to match or best the 48 drugs that got the green light in 2019. The agency also approved a handful of novel biologics and vaccines. Those new products arrived despite the constant stream of diagnostics, drugs, and vaccines in development for COVID-19 that the FDA was evaluating for emergency use. The volume of approvals has been high for several years, but that pace belies a troubling trend, says Bernard Munos, a senior fellow at the think tank FasterCures. Most of this year’s approved treatments were discovered by smaller pharmaceutical and biotech companies rather than the big drug companies that spend billions of dollars each year on R&D. For decades, he says, the output of the 13 largest companies has been fairly flat, despite massive year-over-year increases in R&D spending. That several big pharma

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