Lobby Day Confirms General Goodwill Toward FDA Among Hill Staff

This week, the Alliance ran its third Hill Lobby Day of the year, focused on reminding appropriators and authorizers about the importance of FDA and its continuing funding needs. (Note: the Alliance does more than 200 meetings each year with Congressional offices.)The timing turned out to be good -- Hill staff still had a little bit of time to chat. They probably won’t next week. Many were aware of the House Cures bill (H.R. 6) and the Senate “innovations” negotiations. Also, many were aware of the importance of FDA’s release of two FSMA final rules:

• Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food and
• Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals

We found authorizing staffs were focused on the tremendous amount of new work that FDA would have to undertake under the House Cures bill. Although still in the drafting and negotiating stages, the clear feeling is that the Senate “innovations” bill will also direct FDA to take on many additional responsibilities. Staff on both sides of the Hill understood that any new law coming out of these efforts will need new monies.We expressed appreciation to House authorizers for having been so clear about resources. We urged the Senate to be equally explicit, whether through mandatory funding or an agreement with appropriators. (Note: We were told in several meetings that the money issues will be one of the last items taken up by Senate negotiators.)We found appropriations staffs to be thoughtful about the fate of the 12 committee-passed appropriations bills (in the House, six of those have actually been brought to the floor and passed). Everyone agreed there would be a continuing resolution. Some feared that a shutdown would make even a CR difficult. Others were more concerned with whether a really short-term CR (2 to 10 days) might be in the offing, instead of the 10 weeks that would take the government to mid-December. The consensus was the latter, but not much certainty about the politics of getting there.One trend that was hard to miss: general goodwill toward FDA by Hill staff and a widespread understanding of the difficult job that FDA has. This view was certainly not common when the Alliance started 9 years ago. Since then, the Congress has become more anti-regulatory and even more budget-conscious, yet FDA’s role as “a different kind of regulatory agency with growing budget needs” has engendered appreciation and not hostility. This is not to say that FDA’s activities are free from complaint, just that there is less criticism and the tone and content have changed.This did not happen easily or overnight ... and sentiment won’t remain favorable unless we continue to visit with staff and spread our message of FDA responsibilities and resource needs.Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA.