Janet Woodcock on CDER's Needs and Opportunities

The Alliance was honored to have Dr. Woodcock, CDER director, meet with our members on September 21. For about 40 minutes, she answered questions from a panel of Wayne Pines (APCO, former Alliance President), Peter Saltonstall (NORD, CEO), and Rich Cooper (former general counsel at FDA). The rest of the time she fielded questions from the audience. We had a full house, including a number of reporters who subsequently covered the meeting online and in print.Here are some highlights:

• CDER staffing: They have done some hiring under Cures but have yet to implement the SBRS authority. That will require new administrative procedures to accommodate the new pay system. Overall, hiring is a top priority. However, if CDER hired to its maximum level, it would not have enough office space to house everyone at White Oak.

• If you had more money? In response, Dr. Woodcock talked about the difficulties of implementing the compounding law. More staffing and funding are needed to achieve the levels of compliance that assures safe and effective compounded products. (Subsequently, FDA announced expanded research funding in this area.)

• Possible rare disease center of excellence: There is a lot of work that needs to be done before it could be given serious consideration. Meantime, the agency is proposing a revamp of OND that includes more review units and structured with stronger clinical cohesion. Also, FDA is proposing to create a specific review division for rare diseases and genetics.

• Off-label promotion: FDA enforcement in this area is focused on the truthfulness of claims. Much less is being done on products/campaigns where the disseminated information is accurate but might be considered misleading. FDA is wary of litigating First Amendment issues.

• Patient-focused drug development (PFDD): FDA is fully committed to this process and to greater interaction with patients. FDA is encouraging PFDD meetings that are privately sponsored by disease groups and finding there is enthusiasm for this. FDA still participates at a high level, but doesn’t have to bear the administrative planning and costs. As a result of meetings, the agency is looking differently at the burden of disease and patient expectations.

• Knowledge management: The volume and sophistication of information coming into CDER is vast and the center needs systems that can make knowledge available to whoever at FDA needs it. The existing systems will be further taxed by data coming from real-world evidence, observational studies, patient-reported data, and genetic information. Dr. Woodcock said that CDER needs a knowledge management system that makes information accessible in rational and meaningful ways. According to Dr. Woodcock, this system is critical to CDER’s future, but is hard to sell because it “isn’t sexy.”

The Alliance is interested in organizing more meetings like the one we had with Dr. Woodcock. If there are FDA leaders that you would particularly like to hear from, please e-mail me to let me know.Editorial note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.