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Advocacy at a Glance

October 11, 2013

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.

  • Shutdown Clock: 11 days and counting.
  • They are Talking! A major break in the fiscal crises occurred yesterday, when Congressional Republicans met with the President, and then staff on all sides were missioned to talk through the night. A group of Senate Republicans, led by Senator Susan Collins (R, ME) met with the President today. As of yet, no result of these discussions has been announced.
  • Decoupling of Debt Ceiling and Shutdown (But a Chance of Recoupling). In the last few weeks the separate issues of the debt ceiling and the government shutdown were coupled together into one high-stakes fiscal discussion. In recent days, one of the options being advocated by Speaker Boehner is to provide a 6-week debt ceiling reprieve, but to keep the government shutdown. The President is against this approach. If this negotiating position of decoupling the issues is a surprise to you — it shouldn’t be. Steven Grossman accurately predicted in last week’s Analysis and Commentary that it was a possibility. However, the group of Senate Republicans, who met with President Obama today, would like to see a broader deal that both raises the debt ceiling and ends the shutdown.
  • How Much “Carryover User Fees” Does FDA Have to Work With? Of the FDA employees still working during the shutdown, about 75% (more than 6,000) are attributable to the availability of “carryover user fees.” In response to how much of such funds are available, we have been told: PDUFA has $119.7 million, GDUFA has $152.5 million, and MDUFA has $18.4 million. However, we do not know when each of these pools of money will run out and the staff furloughed.
  • House Passes Mini-CR for FDA. In the last 10 days, the House Republican majority has been implementing a strategy based on passing piecemeal continuing resolutions for various popular parts of the federal government that are closed or partly closed by the shutdown. Each bill would extend funding at FY 13 post-sequester levels through December 15. The bills and strategy are well-discussed here. On October 2, the House passed a mini-CR for NIH and on October 7 passed one for FDA. During the debate on FDA, both Republicans and Democrats expressed strong support for the agency. At this point, the Senate has not embraced the piecemeal funding approach.
  • White House Briefed on Impact of FDA Shutdown. According to Inside Health Policy Week, on October 8, the White House staff briefed President Obama on the impact of the government shutdown on FDA. Reportedly, he was told that the absence of FDA staff was hurting the ability of companies to bring new therapies to market and that patients would be delayed in receiving the benefits of such products.
  • How Did We Get Into This Mess, Anyway? In this week’s Analysis and Commentary, Alliance deputy executive director Steven Grossman updates the negotiating situation as of October 11 and reviews how FDA and other public health agencies reached the current situation where government acknowledges their good work yet undercuts them by squeezing their budgets.

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