Appropriations End-Game Being Discussed 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.

• Appropriations End-Game Being Discussed. The appropriations end-game now has the Hill’s attention and House Speaker Boehner has started to talk aloud about the situation. The trigger for this attention: August is almost here and there are only about a dozen legislative days in September. For more insight into this situation, read this week’s Analysis and Commentary.

• Progress in China Oversight. One of the reasons for upgrading FDA’s China operation has been lax enforcement by Chinese authorities. According to FDA News, the China Food and Drug Administration will begin conducting unannounced inspections of drugmakers, starting this Fall. Given the magnitude of Chinese exports to the US, there will still need to be a strong FDA presence, but this is an early sign that diplomatic engagement by FDA may produce investment by Chinese regulators.

• House, Senate Reports Make Multiple Demands on FDA. As we noted in a previous Friday Update, the House and Senate reports seemed longer this year, containing more directives than we can recollect in the past. The FDA Law Blog put out by Hyman Phelps details how broad and far-reaching the provisions are. While there are a number of very significant directives, none go as far as last year’s report that threatened FDA with loss of $20 million if it did not publish a specific guidance by a specified date. Whether we are seeing a “new norm” or a temporary uptick in directives remains to be seen.