Acting FDA Commissioner Ostroff to Address Alliance on June 3 and more

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.

  • Acting FDA Commissioner Ostroff to Address Alliance on June 3. This coming Wednesday, June 3, at 1 p.m., the Alliance is honored to have Dr. Ostroff present his views on FDA and his current priorities. If you would like to attend this members meeting, please RSVP by e-mail to Tony Curry. This will be one of the first public presentations by the acting commissioner.

  • Appropriations Process to Heat Up in June/July. With all of the recent attention to H.R. 6, it might be easy to lose sight of the Alliance’s immediate and constant priority: increased appropriated resources for FDA. Action on Ag/FDA appropriations is likely to get started in the House in June and the Senate is expected to get started before August recess. Given the pace of the first appropriations bills (quick and easy) and the increasing difficulty as Congress considers harder appropriations bills, it is impossible to predict a timetable. For more on the impending round of appropriations mark-ups, please read this week’s Analysis and Commentary.

  • Cures Legislation Under Review by Other House Committees. Both Houses of Congress are in recess. So, after the rush of activity on H.R. 6, the 21st Century Cures legislation (details here; analysis here), it has been a quiet week in DC. Because the bill reported by the House Energy and Commerce Committee crosses jurisdictional boundaries with other House committees, it will be subject to their review over the next 30 days. Thus, the earliest the House can vote on H.R. 6 would be late June or in July.

    • What reaches the House floor will be (at least) somewhat different from the bill that was reported from committee. House Ways and Means Committee will definitely look at the legislation during the 30-day period and may have changes that they will propose/insist upon. In addition, House E&C chair, Fred Upton, has already told committee members that there will be a “manager’s amendment” as a substitute for the committee-passed bill. While not likely to be dramatically different from the Committee version, this provides flexibility for Republicans and Democrats to discuss areas of continuing disagreement and patch up any ambiguous provisions.

  • Senate Medical Innovation Timeframes Unclear. The House’s intent is for H.R. 6 to meet up with a Senate bill that might be passed in the early fall. This might allow final legislation this year. Based on the Senate’s priorities and pace, this has seemed unrealistic. More likely, a Senate bill might be marked up later in the Fall, with possible final legislation next Winter/Spring. However, there has been some speculation in the media that the overwhelming level of support in the House might place pressure on the Senate to act more quickly. It will be interesting to see whether it plays out that way.

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21st Century Cures: A Good Start Was Essential