Advocacy at a Glance

Advocacy at a Glance offers you the bullet point summary of current advocacy issues associated with the goals of the Alliance for a Stronger FDA.

• Alliance’s Advocacy Day a Success!  The Alliance met with 60 offices this week -- House, Senate, appropriators, authorizers, leadership -- in a broad sweep of those whose opinions matter most when it comes to FDA resources. The most important observations:  FDA is held in high regard by Members of Congress and there is genuine willingness among both Republicans and Democrats to consider new initiatives that would require funding increases for the agency. We still expect it will be a hard fight -- dollars to pay for FDA increases are going to be scarce -- but we couldn’t hope to start from a better position.

The handouts used for Advocacy Day were the following: a fact sheet describing the Alliance’s “ask”; an FAQ; and a sample list of proposed FDA initiatives in the President’s request. A more detailed description of Advocacy Day and what we learned is in this week's Analysis and Commentary.

• Commissioner Gottlieb Testifies Before Senate Appropriations Subcommittee. This past week, Dr. Gottlieb testified on the FY 19 budget request. At the prior week’s House hearing his testimony described two of the agency’s proposed FY 19 initiatives: providing sponsors with disease-specific guidances and new tools that can increase the reliability and lessen the cost of drug development. His Senate testimony focused on two other initiatives: generic drugs and real-world evidence. All of the new initiatives are described on pages 14-20 of the linked PDF.

• Appropriations Schedule is Accelerating: Is This the Year to Restore Regular-Order Appropriations? With FY 19 budget ceilings already set, appropriations bills can move to the floor anytime after May 15. The House and Senate Appropriations Committees are accelerating their hearing schedules, raising the hope that they could finish all or most of the bills before the new fiscal year starts on October 1. So far, the House has held subcommittee mark-ups on Military Construction/VA and Legislative Branch, usually the first two bills to move forward. The Senate has not yet scheduled any subcommittee mark-ups, but they should be starting soon after Congress returns from next week’s recess. Historically, the Ag/FDA appropriations bill is often the fourth, fifth, or sixth one that moves forward from the committees.

The prevailing view is that Congress will try to move most appropriations bills forward, either out of the committee or to the floor ... but will wait until after the election (or early next year) to finalize them. In that case, a Continuing Resolution would fund all or most Departments from October 1 until appropriations bills become law. Nonetheless, the specter of fast committee (and, possibly floor) action raises the possibility that Congress could fund all or most of the government before FY 19 starts. Roll Call reports that a number of Senators are talking about the possibility. Since such “regular-order appropriations” have not occurred in a number of years, we thought readers might appreciate this visual description.

• No Need for a Budget Resolution; but House May Try. The House budget committee may pursue a Concurrent Budget Resolution for FY 19 and eventually bring it to the House floor. The purpose would be for messaging of Republican party priorities, since there is no likelihood that the Senate would consider it. Further, the need for the resolution is negligible with the spending caps (the most important product of the budget process) having already been set for FY 19.