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.

• Acting FDA Commissioner Ostroff Addresses Alliance. At a special briefing for Alliance members this week, Acting FDA Commissioner Steven Ostroff discussed some of the challenges he and the agency face. He emphasized that FDA should be viewed as a science-based, public health agency that carries out some of its work through regulation. He feels strongly (and we agree) that saying “FDA is a regulatory agency” mischaracterizes FDA responsibilities and misstates its mission. He is enthusiastic about H.R. 6, but also very concerned that additional funding become available to avoid cutting back on vital programs.

• 21st Century Cures and FDA Funding. In this week’s Analysis and Commentary, the Alliance’s deputy executive director, Steven Grossman, explores the paradigm shift in funding proposed in H.R. 6. He advocates for recognizing that “not all money is (equally) green.”

• Dueling Rumors on When Ag/FDA Appropriations Will Move.  One source has told us that the House Ag/FDA subcommittee will mark-up in the third week of June and the Senate will be about a week later. In past years, there have been a variety of dates, earlier or later, but these dates are credible because they are consistent with the movement of other appropriations bills this year. Another source told us that farm bill issues and SNAP (supplemental feeding) have created fissures within the committees and that the likely schedule is about a month later than those we had heard (i.e., the third week in July). This also seems credible because we know that Senate Democrats do not want to sign off on spending bills before there is a chance to modify the current ceiling on non-defense spending. We will continue to let you know as more information comes in.

• Senate Dems Plan Hard Line on Appropriations’ Spending Caps. As reported by Politico:

  At a closed-door Democratic leadership meeting Tuesday night, [Senate Minority Leader Harry] Reid (D-NV) vowed that his caucus wouldn't allow a single spending measure to get a floor vote, sources familiar with the meeting say. And on Thursday at noon, his top lieutenants announced their party's intentions to filibuster and prevent Republicans from even calling up the spending measures. 'We will not vote to proceed to the Defense appropriations bill or any appropriations bills until Republicans have sat down at the table and figured out with us how we're going to properly fund the Defense Department ... and our families' domestic needs,' said Sen. Chuck Schumer (D-NY) at the news conference disclosing the strategy.

• FDA Begins Process for Reauthorization of the Generic Drug User Fee Amendments (GDUFA). FDA issued a notice requesting that public stakeholders, including patient and consumer advocacy groups, health care professionals, and scientific and academic experts, notify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Generic Drug User Fee Amendments of 2012 (GDUFA).