The news: Prescription drug approval timelines will shrink under an FDA pilot program that will reduce the approval timelines from a typical 10 months to just 1 to 2 months.

Zooming in: The FDA will issue a limited number of priority vouchers in the first year to companies it believes support US national interests, such as increasing US drug manufacturing. 

Under the program, pharma and biotech companies will submit most of their drug applications before clinical trials are finished. FDA reviewers will adopt a medical team model, with reviewers evaluating submitted data and then gather for a 1-day meeting.

Zooming out: The current drug approval process takes 6 to 10 months after FDA submission. Companies can already earn priority review vouchers to use in the future after getting an approval for rare pediatric or neglected tropical diseases.

Why it matters: Faster drug reviews save time and money for drugmakers and can speed needed treatments to market.

• The average time to develop and get a drug approved in the US is 10 to 15 years, per pharma trade group PhRMA, and costs about $1.3 billion, per a recent JAMA study.
• Expedited drug approvals can be worth up to $5 million in late-stage trial savings alone, per a Harvard Business School study, although it also concluded that faster approvals may not be appropriate for all drugs.
• The FDA did not say specifically how generative AI tools would be used to speed along the new priority program, but Commissioner Marty Makary earlier this month introduced its new “Elsa” AI tool to speed up drug, medical device and food safety reviews.

Yes, but: Slashing review time comes with risks. Truncated or AI-aided regulatory reviews trade detailed scrutiny for speed and tech-aided shortcuts. Generative AI issues like hallucinations and data bias are concerns and medical, legal, reviews still require human oversight, per Klick Health.

Our take: Speedier reviews and new AI programs for drug developers are good ideas, but pharma companies should remember the COVID-19 vaccines speed-to-market backlash and weigh the time benefit against whether their drugs will gain trust with physicians and patients.

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