The Alliance Elevator Speech for 2015 ... Please Learn and Repeat

The Alliance meets with elected officials and their staff year-round. Even still, our annual lobby day (March 18) is special -- the chance to interact with 50 or more offices in a single day. With House and Senate budget resolutions and the appropriations cycle having begun, lobby day falls at the exact right time in the Congressional schedule.This gives me a chance to set out the “core narrative of FDA funding” -- the one we need to be delivering at every Hill office on lobby day and which every Alliance member should consider as the basis of their “elevator speech” on FDA funding. It goes like this:

A decade ago, FDA was a severely underfunded public health and regulatory agency with responsibilities for products that represented more than 20% of consumer spending. Despite several highly-visible problems during this period, FDA had no prospects for improving its funding situation.

This stimulated agency stakeholders to come together (the next year) to advocate for a better resourced FDA. Soon after (the next year), the FDA Science Board issued a report that stated bluntly that the agency’s problems could not be solved without a substantial increase in funding.

The combination of advocacy and the Science Board report led Congress to provide increased resources to FDA in four consecutive years, with two of them involving exceptionally large increases. The effect was to provide the agency with arguably enough resources to carry out its core mission, as it existed four to six years ago.

About this same time, Congress started to add to the agency’s responsibilities in a series of bills that passed annually from 2009 to 2013. A chunk of this was paid for (in whole or part) by new user fees programs (tobacco, generics, biosimilars) and increases in existing user fee programs (drugs, devices).

However, another large chunk of the new responsibilities (particularly food, medical innovation, drug safety, compounding and globalization) were ones that could not be paid for by user fees (or were inappropriate for user fees). It is these programs -- mandated by Congress -- plus increasing scientific complexity and growing industries -- that leave FDA needing a larger budget authority appropriation. Substantial progress toward safer foods and safer and more effective medical products is put “at risk” without it.

In sum, after the increases of the last decade, FDA has roughly enough money for the FDA that existed a few years ago, but not for the FDA of 2015.

Please keep delivering these messages. Join us for lobby day if you can.

Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA.