What Authorizers and Appropriators Are Doing -- The Disconnect

Congress is away this week ... before returning for a long stretch (with one more short break) that will take them to the August recess. The appropriations/budget impasse continues, with the appropriations process likely to be slow and not definitive until that is resolved.For those who came in late or just want a refresher on the process and where FDA stands within it, we have attached an FDA budget primer/FAQs.  If that stimulates further questions, please let me know and we will address them in subsequent Friday Updates.

Since nothing moved this week with Congress away, I wanted to return to one of the Alliance’s favorite topics: the massive disconnect for FDA between what authorizers are doing and what appropriators are doing. As has been chronicled here, Congress has passed five new laws affecting FDA in 4 years (2009-2012), including tobacco regulation, biosimilars, food safety, and FDASIA initiatives (which include drug and device changes plus a large new generics program).  This year, Congress is working hard on animal drug user fees, track and trace/counterfeiting, and compounding, and there are a number of topics under consideration for possible action sometime this year or early next year.

Clearly, the authorizing committees -- on a bi-partisan basis -- see the need for more federal activity within FDA’s jurisdiction. Historically, the 4.5 years since January 2009 would rate as among the most active periods for Congressional initiatives affecting FDA. The enormity of this is even greater if you look at how little substantive legislation Congress has passed during this same period and how even some of that legislation (e.g., Obamacare) was not bi-partisan.The truth is that bi-partisan legislating has become rare and, when it happens, it is the product of unusual processes (e.g., Senate “gang of eight” working on immigration reform). In contrast, FDA legislation seems to be hard-fought, but there is steady pressure to work through differences. Ideology may affect some of the provisions, but are not a barrier to adoption of legislation and new responsibilities for FDA. What we have come to call “FDA exceptionalism” (why FDA needs increased resources regardless of the overall or specific budget situation) is alive and well on the authorizing committees.In contrast, the House and Senate budget committees and the Budget Control Act of 2011 are creating a steady downward push on federal spending, with FDA one of the (perhaps unintended) victims. This has put appropriators in a position where their traditional role can’t be fulfilled  (picking higher priorities to fund and providing lesser funding for lower priorities). Under a traditional appropriations process, we feel confident that FDA will receive the extra funding it requires.To be fair to appropriators, they have squeezed extra dollars out for FDA’s benefit in each of the last few years. But they could not shield the agency from sequester and they have not been willing to say out loud: I am prepared to find offsets to assure increases for FDA. We recognize that they are working under incredible pressures and constraints ... indeed, we are sympathetic to their plight.Nonetheless, we need appropriators to see what the authorizers see: that no amount of budget pressure makes it a good idea to create an under-resourced FDA when there is so much work that still needs to be done. Both existing and new responsibilities will go unmet without the needed dollars to support staff and programming. Consumers, patients and a highly-productive industry are all losers without an adequately-funded FDA.

Note: This analysis and commentary is written by Steven Grossman, the Deputy Executive Director of the Alliance for a Stronger FDA.