153 new drugs approved by the USFood and Drug Administration during the last 30 years were discovered by researchers in the public sector, and over half were for the treatment or prevention of cancer or infectious diseases, says new research.
Moreover, 46.2% of drugs discovered by public-sector research institutions (PSRIs) during the period received priority review by the FDA, compared to 20% of applications that were based purely on private-sector research, according to the study, which has been published in the New England Journal of Medicine (NEJM).
PSRIs contributed to up to 21.2% of all products involved in new drug applications (NDAs) approved by the FDA during 1990-2007, a higher proportion that was previously thought, say the researchers, who are from Boston University and the National Institutes of Health (NIH). “Our data also suggest that PSRIs tend to discover drugs that are expected to have a disproportionately important clinical effect,” they add.
The 153 new FDA-approved drugs, vaccines or new indications for existing medicines which were discovered through PSRI research during the period include 93 small-molecule drugs, 36 biologics, 15 vaccines, eight in vivo diagnostic materials and one over-the-counter drug (OTC).
Particularly noteworthy is the large number of vaccines on the list, say the researchers, who note that “virtually all the important, innovative vaccines that have been introduced during the last 25 years have been created by PSRIs.” Moreover, 39 of the products received an orphan drug designation, they add.
The research also shows that a total of 75 PSRIs discovered or codiscovered at least one of the 153 products, the most prolific being the NIH, with 22 discoveries, followed by the University of California (11 discoveries), Memorial Sloan-Kettering Cancer Center (eight), Emory University (seven) and Yale University (six).
Historically, there has been a clear distinction between the roles of public-sector and corporate research in the discovery of new drugs and vaccines, with PSRIs performing the upstream, basic research and companies conducting the downstream, applied research and then carrying out the development work to bring the new treatments to market. The intellectual property (IP) that protects the investment in developing the new products is created in the applied-research phase.
However, the emergence of biotechnology in the mid-1970s, combined with policy changes implemented in the early 1980s regarding the ownership and management of of PSRIs’ IP, allowed these institutions to play an important role in this phase of drug discovery, say the authors.
These new findings suggest that public-sector research has had a more immediate effect on improving public health than has been previously realised, and they have economic and policy implications, they say.
“We hope our research will help inform the amplified conversation taking place around innovation policy in the US and abroad,” noted study co-author Jonathan Jensen, director of business development, technology development at Boston University.
“The factors involved in bringing a single one of these drugs to market are complex. With a more comprehensive understanding of the contribution of the public sector to the development of FDA-approved drugs, as our work attempts to establish, one can better appreciate and further study the factors involved the transfer of knowledge from the public to the private sector,” he added.
