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.

• October 1 Came and Went: CR Covers FDA Until December 7.  As expected, conferees were not able to reach agreements on the four-bill minibus before the House recessed until after the election. While not the cause of the delayed action on the four-bill minibus, it had been reported that there were two unresolved issues in the Ag/FDA portion:  a provision regarding the federal dispute over cell-based meat and another that would effectively block public disclosure of certain data from retailers on food stamps transactions.

With a minimal number of remaining issues to resolve, the assumption is that the four-bill minibus will pass soon after Congress returns. However, CR’s are tricky and post-election sessions are unpredictable. Our take on the situation is this week’s Analysis and Commentary.

• Gene and Cell Therapy Applications Increase Dramatically. The number of BLAs for gene and cell therapy products increased by 25% between 2016 and 2017 and doubled between 2013 and 2017 (see chart here). This illustrates a point that appears often in Alliance documents: the scientific complexity of the FDA’s workload keeps increasing every year. The agency needs the resources (budget and well-trained personnel) to keep up.

• Farm Bill Negotiations Continue. Congress missed the September 30 deadline for reauthorizing the Farm Bill and negotiations will continue while the House is out of session. As previously noted, the Farm Bill does not affect FDA directly, but could affect the Ag/FDA appropriations bill.

• Coming Soon: More Alliance Briefings By FDA Officials.  Following September’s well-attended Alliance meeting with Dr. Woodcock, we are planning more briefings. Presently, we are working on dates for a meeting downtown with Center for Veterinary Medicine Director Steve Solomon. CVM has been described as a “microcosm of FDA, with activities in veterinary pharmaceuticals, stem cells, veterinary devices, animal and human food safety, antimicrobial resistance, research, and outbreak response.” In past years, the CVM briefing has been among the most interesting, in part because the scope and implications of CVM’s work isn’t widely understood. Alliance members and media should let us know of their interest in attending by e-mailing Steven Grossman. We will follow up when a date is set.