Faster FDA Reviews Cut Red Tape, But Critics Wonder at What Cost
In a drug industry where accurate timelines are crucial, the perception that the FDA is becoming arbitrary and gameable is bad for business, or at least for clarity.
Illustration: Sebastian Cestaro for Bloomberg Businessweek
In November, what was supposed to be a marquee announcement of lower prices for the blockbuster weight-loss drugs from Novo Nordisk A/S and Eli Lilly & Co. went viral for the wrong reason: An onlooker collapsed in the Oval Office, and it was captured on livestream. The episode ricocheted across social media and into late-night monologues, with millions of viewers who’d skipped the original announcement tuning in to rewatch the almost made-for-TV fainting clip.
Far less attention was paid to the substance of the event. But for informed viewers, it was equally dramatic. After the commotion subsided, US Food and Drug Administration Commissioner Marty Makary praised Novo and Lilly for lowering their drug prices—a major win for President Donald Trump’s domestic agenda—and awarded each company a voucher guaranteeing faster-than-normal FDA review for a future medication. As the exchange made abundantly clear, in Trump’s Washington, even the speed of a federal drug review is up for negotiation.