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Miller, H. FDA not NIH can speed new drugs. Nature 472, 169 (2011). https://doi.org/10.1038/472169a
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DOI: https://doi.org/10.1038/472169a
asok banerjee
This is a very timely article and I must congratulate Prof. Miller to be the first one to step forward and bring it up. Hundreds of american citizens suffering from deadly diseases cannot take medications just because they are not approved by the FDA.
Samuel Hasson
While I respect Dr. Miller's opinion that the FDA can speed the approval of more drugs I do think that there are distinct advantages to having the NIH in a more streamlined drug development process. Dr. Miller overlooks the fact that many diseases are not pursued for pharmaceutical development because the simply don't have the potential for return-on-investment. Rare disease and limited-term treatments such as antibiotics are areas where the NIH can bring new therapeutics from the bench to patients with the new center. There are many cases where the incentive for industry to develop new therapeutics just isn't there given the massive expense and resource requirement. The NIH could fill in this gap and help many Americans who currently have no hope for treatment.
Also, there are significant business risks to devoting resources in any new campaign. The NIH plan is to help minimize or eliminate the risk that keeps pharma out of certain target areas. This is especially true for emerging targets that are not on the radar of industry. With discoveries every day from NIH funded labs, the NIH teams are in a position to quickly integrate assay development, drug discovery, characterization, and pre-clinical development into the existing NIH framework.
I think writing off the NIH drug development efforts completely is a mistake. The bottom line is that the NIH has been involved with drug development for a long time. From discovering novel therapeutic agents (taxol for example) to gathering clinical data and running clinical trials, the government research has played a significant role.
John Dong
As a CEO of biotech company, I could not agree with Prof. Miller anymore. NIH has been doing very good jobs in area of drug discovery particularly in emerging markets out of industry radar screen. Under current budget constraint refocusing NIH effort on product development will likely reduce the available funding for discovering research. Let biotech does its best with some incentive from NIH funding (i.e., SBIR award). It is FDA needs to be updated and innovated to speed up new drug development.