The news: Prescription drugmakers can now apply for new Trump administration priority review vouchers that will cut drug approval times down from 10-12 months to just 1-2 months.

Digging into the details: FDA chief Marty Makary opened online applications this week for the plan now called the Commissioner’s National Priority Voucher (CNPV).

• The FDA plans to hand out 5 vouchers on a rolling basis this year.
• Applicants need to show they’re committed to at least one of five Trump administration healthcare priorities: addressing a public health crisis, delivering innovative cures, tackling an unmet medical need, moving drug development and manufacturing to the US, or reducing drug costs.

Zooming out: A growing group of pharma companies are pledging significant spending to US manufacturing and R&D under Trump pressure. This week, AstraZeneca promised $50 billion over five years earlier.

• It follows pledges from Roche ($50 billion over five years), Johnson & Johnson ($55 billion over four years), Eli Lilly ($27 billion in new spending on top of $23 billion already promised), Merck ($1 billion on new factory), and Biogen ($2 billion to build out a current site).
• The already promised investments could put them at the front of the CNPV line.

Why it matters: Speedier drug approval times mean more time on market and a same-class competitive advantage.

Under the current priority review voucher (PRV) system—which will continue alongside the CNPV program—drugmakers can buy PRVs from each other. The most ever paid for a PRV was $350 million by AbbVie in 2015, although the current price is around $150 million, per a recent BioSpace review.

Our take: Good faith commitments for US drug onshoring investments could translate to valuable advantages if those drugmakers can leverage those into a CNPV. But with so many pharma companies already in that pool, we expect this year’s winners to be drugmakers who can show real evidence of two, three or even all five priorities on the Trump administration list.

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