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.

• CR Runs Out on December 8: Will There Be a Budget Deal or a Shutdown? Before completing appropriations, Congress needs to increase the budget caps for FY 18 to avoid a sequestration of defense spending. A 2-year deal is also possible to avoid a repeat next year before the elections. At this point, it is unlikely that both budget and appropriations deals can be worked out before the current Continuing Resolution runs out on December 8. There is no consensus yet on whether a further CR should be for 1, 2, 5, or 8 weeks, but there could be an announcement on this soon. The alternative -- either next week or when a subsequent CR expires -- is that there will be a government shutdown. Rhetoric from the President and others suggest that this is a possibility, however remote. As a result, we have received a number of inquiries about would happens to FDA in a government shutdown. This is discussed in this week’s Analysis and Commentary.

• Commissioner Gottlieb Testifies Before House E&C on Implementation of 21st Century Cures. On the first anniversary of the passage of the 21st Century Cures Act, the House Energy and Commerce Committee held a hearing to assess progress in implementing the law. NIH Director Francis Collins and FDA Commissioner Scott Gottlieb testified and provided the committee with an overview and agency’s accomplishments in the intervening year. Dr. Gottlieb’s testimony and the hearing materials and video are available. The Senate HELP Committee plans to hold a similar hearing on December 7.

• FDA/Pentagon Impasse Resolved; FDA Jurisdiction Preserved. During Congress’s development of the National Defense Authorization Act, a provision was added that would have given DOD jurisdiction over the approval of drugs and devices intended for use on the battlefield. FDA’s authorizing committees objected strenuously. After some back and forth, a compromise was reached. FDA preserves its jurisdiction, but has committed to working more closely with DOD to assure expeditious review of therapies intended for the military. It is a reminder that FDA’s integrity is one of its most important assets and that policymakers and stakeholders always have to be prepared to fight for the agency.