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.

  • Congress Returns; Appropriations Bills Advance. On September 6, the House of Representatives voted to go to conference with the Senate on the minibus bill, HR 6147, that combines four bills, including Ag/FDA funding. That finished a week in which conferees continued to work on the first minibus and conferees were appointed on the third minibus -- which combines Labor-HHS and DOD programs.

Appropriators want to get their bills across the finish line by October 1 or, failing that, achieve passage during early October before recess. So far, they seem to have the full support of leadership. The obstacles are a short calendar, House bills with a lot of policy riders that the Senate cannot accept, House members wanting to go home to campaign as soon as possible, and the lack of direction from the President about what bills he will sign and on what terms. With so many possible outcomes, this week’s Analysis and Commentary looks at the more probable scenarios and how Ag/FDA funding might fare.

  • September’s Here. Time to Sign Up to Hear CDER Director Woodcock Presenting to the Alliance on September 21. The Alliance is honored to be hosting Dr. Woodcock on Friday, September 21, at 9 a.m., at a location near Dupont Circle. Her remarks should be particularly pertinent given the Administration’s strong FY 19 funding request for medical product programs and the proximity to the end of the fiscal year.  If you would like to attend, RSVP by e-mail to Eden Shiferaw.
  • Commissioner Gottlieb Uses FDA Voice Blog Column to Discuss Regulatory Modernization. The Commissioner touches, among other things, on advances in clinical trial design, more predictable and transparent regulatory decisions, and expansion of the agency’s capacity to analyze real-world evidence. His column is here.
  • Passage of Farm Bill Could Be Trigger for House to Go on Recess. Last week’s  Analysis and Commentary looked at the impact of post-election sessions on the movement of appropriations bills. One pivotal consideration: Speaker Ryan will want to send his troops home to campaign as soon as possible, regardless of the status of appropriations. What would hold them in DC? Some are saying that that the Farm Bill is must-pass before the election. Once that’s done, the House may not stay around to conduct other business.
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Timing, Knowns, and Unknowns: FDA's FY 19 Appropriation

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On the Physical Capabilities of a Lame Duck