FDA Matters Blog
Register to get regular updates from FDA Matters FDA Matters Home

NIH and Drug Development: Dr. Collins’ New Initiative

Dr. Francis Collins, director of the National Institutes of Health (NIH), wants to create a new National Center for Advancing Translational Sciences (NCATS) at NIH.  The new Center would combine $700 million in existing NIH projects with, perhaps, an additional $300 million from new monies or other NIH programs. NCATS is intended as NIH’s “response” to the biopharmaceutical industry’s failure to produce more new drugs.

FDA Matters doesn’t see the sense of creating a public sector drug development company. Nothing suggests that government has either the requisite knowledge or experience to succeed. Yet, several people I respect are supportive of Dr. Collins’s initiative.

Advocates and critics of NCATS may not be talking about the same thing. NIH describes a very circumscribed process in which NIH quickly passes early research over to industry. NIH will do compound screening, animal studies and sometimes proof of concept human clinical trials. Since NIH already does this without a lot of fanfare, why create a new center rather than just highlighting the work?  

The NIH FAQ also promises that NIH will limit itself to less developed clinical areas where there is not yet commercial interest by industry. The notion that NIH will restrict itself in this way rather than pursue best scientific opportunities…is worth at least a raised eyebrow of skepticism.

Industry is frustrated by the difficulties of developing new medications and is actively searching for ways to do better. Maybe they could use some more help from NIH. Unfortunately, HHS and NIH have taken a less cooperative approach, trying to sell NCATS as a response to industry failures in new drug development, as if they are certain of the cause and know that NIH can do better.

It would be better if government officials focused instead on expanding NIH’s existing role in developing medical knowledge beyond basic research. Congress has shown considerable interest in this over the last few years and, until now, there have been few questions about whether NIH is overstepping its bounds.

NIH implies that NCATS will be a productive goad to an unproductive pharmaceutical industry. Whether this is justified, it would help the discussion if NIH were to be more upfront about its limited expertise in developing products to meet FDA’s standards for approval.

Because of the difference in the two agency’s missions, FDA’s standards are much higher and less forgiving. This is appropriate: we want NIH to advance knowledge; we want FDA to make sure that biopharmaceuticals are safe and effective.

Dr. Collins’ initiative also seems hasty in its desire to re-organize upwards of a billion dollars in NIH’s programs by October 1, 2011. It is seductive to imagine that problems can be solved by redrawing boxes on an organizational chart. Sometimes this works, but more often you get the Department of Homeland Security, an organization that is far less than the sum of its parts.

For the moment, there appears little talk about the possible impact on the rest of NIH if NCATS is created. If $700 million worth of programs is transferred to NCATS and Dr. Collins says he will squeeze more money from other priorities, how can existing institutes and centers not suffer? It would be quite unfortunate if basic research were to be devalued by the rise of translational science.

NIH, as an institution, may not be better off with NCATS.  In any case, new drugs are not going to pour out of NIH, as some seem to believe. 

I’d like to see a lot more public discussion of these issues. Let’s take the time to be sure that the integrity and productivity of NIH are not at risk and that the American people will receive tangible benefits.


NIH’s FAQ and website on the proposed changes: http://feedback.nih.gov/index.php/faq-ncats/

The interview of Dr. Collins by Gardiner Harris of the NY Times:


From Pharmaceutical Executive on-line:
NIH Director On the Consortium’s New Remit
As the National Institutes of Health hits the headlines over its remit to help develop new medicines, Director Francis Collins talks about the new initiatives he sees as critical for innovation, industry, and public health.

Leave a Reply

You must be logged in to post a comment.

© 2009-2012 by HPS Group. All rights reserved. Permission is hereby granted to those wishing to quote or reprint from this site, providing it is properly attributed to FDA Matters: The Grossman FDA Report™.