RUC Outta Luck

Yesterday the FDA held a “stakeholders” call to discuss the agency’s FY 2012 budget.  Specific information will be shortly posted on the FDA website.

After a brief intro by Commissioner Hamburg, the heavy lifting was done by Patrick McGarey, Director, Office of the Budget.

Two items of particular note:

1- Within the 2012 budget is an allocation for $25 million for “advancing regulatory science.”  (In fact, the Commissioner made specific note of the need for this in her opening remarks.)  During the Q&A session, I asked what non-user fee monies were being allocated to the Reagan/Udall Center (RUC).  The answer was, “none.” 

That’s both disappointing and surprising since the (still not approved) fiscal 2011 FDA budget included $25 million for “scientific modernization under the Advancing Regulatory Science Initiative (ARSI).  ARSI, as it was described at the time (February 2010), is a cross-center program whose ultimate objective is to provide FDA scientists with the skills to evaluate the safety, effectiveness and quality of products developed with new and emerging technologies, as well as give industry the standards by which such products will be judged.

Included in the 2011 budget for ARSI was $4.45 million in funding for the Critical Path Initiative. Why was that allocation zeroed-out?  And all of this assuming the President gets full funding for his budgetary requests – which is not likely.

2- Mr. McGarey mentioned that the agency was working to develop a pathway for biosimilars that would be used “after the innovator’s patent had expired.”  I asked if that meant that the agency had decided that the legislation that created a framework for such a pathway was based on patent life or data exclusivity.  His answer, “I can answer with 100% certainty that that isn’t a budget question.”  I hope that means he misspoke.

Lack of money is the root of all evil.
 -- George Bernard Shaw