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.

• Maximum of 12 Legislative Days Before Election Recess. Congress plans to return from recess on September 8 and go straight to work on a broadly acceptable (if not totally clean) Continuing Resolution. The House will be on lead. If the House falters, the Senate will initiate the CR. Once the CR is passed and signed by the President, Congress will adjourn by October 2 (maybe much earlier) and go home to campaign. Here is House Speaker John Boehner’s description of his September priorities and here is a subsequent story with more details from House Majority Leader Kevin McCarthy. What could go wrong? Probably nothing, but agreement on goals (clean CR, go home to campaign ASAP) is not the same as agreement on content and process. So, political reality, as described here, may still upset Congressional plans for September.  This week’s Analysis and Commentary also looks at the September agenda.

• A Continuing Resolution Seems Inevitable, What Will It Look Like? The main piece of Congressional business in September is to pass a Continuing Resolution to continue government operations when the current fiscal year ends. The CR will fund the federal government from October 1 until after the election, probably until December 11. We expect the CR to be set at FY 14 spending levels and to contain a minimum number of anomalies (special exceptions). In particular, new programs starts will not be allowed unless covered by an anomaly. A fuller description of the CR process and issues was previously offered.

• FDA Approval of New Molecular Entity Drugs Up So Far in 2014. According to Dickenson’s FDA Webview: “CDER is on track to substantially exceed last year’s 27 new molecular entity (NME) drug product approvals. Through August, the Center has already approved 25 NMEs, according to drug approval reports reviewed by FDA Webview. Approval numbers have been bolstered by 12 NME approvals over the last 2 months, and the current approval pace could see CDER surpassing the 39 NMEs approved in 2012. Over the past 10 years, annual NME approvals have averaged 26, according to FDA officials.”

• The Political and Technical Aspects of Sequestration are Multi-faceted and Complex. Another, earlier Analysis and Commentary was devoted to a Q&A that attempts to answer questions raised by some of the Alliance's members.