“Over the 18-year period from 1990 to 2007, the FDA approved a total of 1,541 NDA applications but granted priority review to just 348, or 23%, of the applications. […] Nearly half (46%) of NDAs from PSRIs, including NIH-IRP contributed drugs, received priority review; in contrast, one-fifth (20%) of the applications based on private-sector and non-US inventions were granted priority review.”
FDA priority review is used as a proxy for ‘benefit the drug will give to public health’, as this is (theoretically) why the FDA grants priority review.
“Drugs developed from NIH-IRP inventions are represented among drugs receiving priority review at a rate […] 4.7 times higher than those solely from the private and non-US sectors. Although representing a small fraction of all drug inventions, NIH-IPR technologies have contributed substantially to meeting otherwise unmet public health needs.”
FDA = Food & Drugs Administration (main US drug-approving body)
PSRI = Public Sector Research Insititution. = all public research in the US, in context of this article.
NDA = New Drug Approval
NIH = National Institutes of Health
NIH-IRP = NIH-Intramural Research Program – intramural = ‘within walls’. NIH also funds research ‘outside its own walls’. NIH-IRP is a PSRI.
Nature Biotechnology 32, 52–58 (2014) doi:10.1038/nbt.2785
Published online 09 January 2014