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.

• Federal Deficit Certain to Grow Over Next 10 Years. As often discussed in the Alliance's weekly updates, the monies available for spending on discretionary programs, such as FDA, are heavily influenced by the cost of mandatory spending, such as Medicare, and the acceptable level of annual deficit spending. A snapshot of the situation is provided in a CBO summary of its new budget and economic outlook. The full report is to be released on January 25. The bottom line is that mandatory spending is going to continue to increase faster than revenues and that deficit pressures are going to increase at a higher rate than previously projected. The deficit is not driven by the cost of discretionary programs, but discretionary spending is often the first target.

• Cures/Innovations Legislative Process Restarted. Rather than follow the House Cures bill’s comprehensive structure, the Senate HELP committee has chosen to mark-up up individual bills on specific topics in its Innovations legislative process. After at least three mark-ups that have already been scheduled, the expectation is the proposals will ultimately be rolled up into a single bill, i.e., in a format that would facilitate negotiations between the House and Senate. Even though the Alliance doesn’t have a position on the content of either Cures or Innovations, we are very interested in the legislation and whether and what provisions might become law. This is explained in this week’s Analysis and Commentary.

• CDER: 2015 Accomplishments/2016 Priorities. CDER center director Janet Woodcock has done a podcast looking back at 2015 highlights and looking forward to 2016 priorities. For 2015, she pointed to work in generic drugs, transformation of FDA’s approach to pharmaceutical quality, and approval of the first biosimilar. Priorities for 2016 include: user fee negotiations, OTC monograph reform, and addressing the opioid abuse epidemic. Interestingly, in both the looking back/looking forward parts of the conversation, she references the need to improve and accelerate hiring. Asked at the end of the interview whether there was one thing that would matter most, she replied, “If I could have 800 people on board this very minute who aren't here right now, I think we'd all be in a much better position to get all this done in the next year.” (Click here for a transcript of the podcast.)

• Prospects for Califf Confirmation Still Unsettled. Dr. Robert Califf’s recent approval by the Senate HELP Committee gets him a step closer to full confirmation. If Dr. Califf’s nomination can get by any “holds” and reaches a floor vote, he is widely considered to be a shoe-in for confirmation.