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.

• President’s Full Budget Release Set for May 23. President Trump released his so-called “skinny budget” in mid-March, providing us with an ominous warning that new proposed user fees were likely to be a centerpiece of his request for FDA. We have since confirmed that some or all of those new fees are intended to offset a proposal to substantially decrease FDA’s budget authority appropriations. The number suggested in the skinny budget was $1 billion in new medical product user fees to replace $1 billion in FDA’s base BA appropriation level of $2.75 billion. While final numbers might vary, at that level it would be a 37% cut in taxpayer-funding of FDA.

We are hopeful (but not necessarily optimistic) that the Administration has abandoned this approach and will continue to maintain support for the vital activities at FDA. We will know on May 23 when the President’s full budget is released. Next week, we will devote much of Friday Update, including the Analysis and Commentary section, to explaining what to expect. Our goal is to reduce the confusion that occurs each year because OMB always tries to make the President’s FDA request look far more rosy than it is.

• Senate Holds User Fee Mark-up. The Senate HELP Committee took the first step this week in advancing the reauthorization of medical product user fees for FY 18-22 and the House Energy and Commerce Committee mark-up is likely to follow soon. Both Senate and House are committed to sending a bill to the President before August. Although FDA’s budget authority (BA) appropriation is the Alliance’s focus, the timing of the 5-year user fee reauthorization and the likely Administration proposal to cut BA and replace it with user fees, makes this a good time for Analysis and Commentary to provide background on how BA and user fees compare.

• New Commissioner on the Job: As described on the FDA website: Dr. Scott Gottlieb was sworn in as the 23rd Commissioner of Food and Drugs on May 11, 2017. Dr. Gottlieb is a physician, medical policy expert, and public health advocate who previously served as the FDA's Deputy Commissioner for Medical and Scientific Affairs and before that, as a senior advisor to the FDA Commissioner.