Advocacy at a Glance

Jun 9

Written By

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.

You Have Questions About FDA and the Federal Budget. ... We Have Answers. Now that the President’s FY 18 Budget Request has been released (more detail here) and Congress has returned from Memorial Day recess, the budget and appropriations process will accelerate. Some type of conclusion will be needed by October 1, the first day of the new fiscal year. This will be so, regardless of whether all the issues have been resolved. This week’s Analysis and Commentary answers some of the questions we’ve been asked about what lies ahead.

First Appropriations Bill Goes to Mark-up in the House. The House has scheduled its first FY 18 subcommittee mark-up for June 12, covering Military Construction and VA. However, this may not be an indication that the House appropriations committee is ready to move forward on other bills. Over the last few years, the Mil-Con/VA bill -- non-controversial and bipartisan -- has moved ahead of the rest of the process, often by a significant amount of time. In those prior years, the Mil-Con/VA subcommittee was told how much money it could appropriate long before there was a decision on aggregate spending levels or a split of the those funds among the other 11 subcommittees.

House Energy and Commerce Committee Adopts User Fee Bill. This week the House Energy and Commerce Committee, by a vote of 54-0, advanced FDARA -- the FDA Reauthorization Act. The bill renews four medical product user fee programs, covering prescription drugs, generic drugs, medical devices, and biosimilars. The user fee funding levels in the bill reflects the agreements reached by FDA and industry over the last 2 years of negotiation. As with the Senate bill adopted by the HELP committee, the House has not given consideration to the President’s budget request that would have added about $800 million per year in new and additional user fees that had never been discussed with FDA or industry.

The Realities of the FY 18 Budget; Some Qs&As