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.
- Congress on Recess for Next Five Weeks. The Senate left last night after passing VA reform legislation and a short-term extension of highway trust fund authority. Both will go to the President for signature. The House is still considering whether it can reach a compromise on the President’s request for funding to deal with the immigration crisis on the border with Mexico. We expect by the time you read this, the House will probably be gone, too. Congress returns on September 8 and is currently scheduled to adjourn by October 2 or sooner for the election. Everyone expects a lame-duck (post-election) session.
- FDA Funding/Focus on CDER Resources. A few weeks ago, the Alliance and a number of its members met with senior leaders of the Center for Drug Evaluation and Research (CDER). Notably, Dr. Janet Woodcock, the Center Director led the meeting and, among others, we heard from Dr. John Jenkins, director of the Office of New Drugs. We heard about resource issues affecting every part of the Center, reflecting perspectives from the budget office, planning evaluation, and the review divisions. There were two sets of hand-outs from the meeting. The first set of slides looks at some particular aspects of the CDER budget. The second set at the breakthrough drug program.
Among the points made at the meeting and reflected in the first handout:
- FDA’s key Sentinel program—developing a robust post-market surveillance system—has been funded unevenly and is no longer growing.
- Since FY 11, CDER’s budget authority funding has remained fairly level, almost all the growth has been increases in user fees.
- An increasing portion of FDA’s BA appropriation is devoted to meeting the maintenance of effort requirement in the user fee program
Among the points made at the meeting and reflected in the second handout:
- So far, FDA has granted 52 breakthrough designations (BTD) (as of June 30, 2014) out of 167 applications received.
- Of the applications, about 18 to 20 are currently pending, the rest have been approved, rejected or withdrawn.
- 15 review divisions have received at least one application and 11 review divisions have at least one approved (break-out by division is shown).
- The bulk of designations have gone to hematology, anti-viral, and oncology programs.
We asked: Is the BTD program drawing resources that would be going elsewhere? We were told that the program has drawn far more interest than CDER expected and thus used more resources, but it is too early to know whether other parts of CDER have been affected.
- FDA in White Oak to Have New Neighbors. There are significant amounts of land adjacent to the White Oak campus. Montgomery County has been actively considering proposals and this week the County Council approved a mixed use global life sciences community on one of the larger parcels. While the goal is to increase jobs and economic activity in the northeastern part of the county, it should also substantially increase the amenities available near the FDA campus