The EveryLife Foundation for Rare Diseases delivered a letter of support for the nomination of Dr. Robert Califf as Commissioner of the Food and Drug Administration (FDA), signed by 52 patient organizations.
As the Senate held a hearing today to consider his nomination, the signers urged Members to take immediate action to confirm Dr. Califf. The signers emphasized Dr. Califf’s previous experience as FDA Commissioner, his leadership in innovative clinical trial design and translational medicine and his work with large data initiatives as evidence that he will continue to improve the FDA’s drug approval process so that patients receive safe and effective treatments at the earliest moment possible:
“Most important to us, the undersigned, is that the FDA must continue to expand upon the patient focused drug development momentum, including patient communities and clinical experts as key stakeholders within development and regulatory review. Patients are key partners in all aspects of health, and in all phases of the continuum in therapy and intervention development. Dr. Califf’s professional experiences and work with large data initiatives will enhance the FDA’s efforts to identify how best to incorporate patient reported outcomes into the FDA review process.”
The letter was sent to HELP Committee Chair Senator Patty Murray and Ranking Member Senator Richard Burr. View the letter.
In addition, the Foundation’s Board Chair, Mark Dant, expressed support for Dr. Califf’s nomination:
“As a parent advocate, I know how important it is to have an FDA Commissioner like Dr. Califf who appreciates the patient voice and understands the critical role of patient representation in the development of therapies that impact their lives,” said Mark Dant, EveryLife Foundation for Rare Diseases Board Chair. “We are looking forward to working with Dr. Califf and continuing to build upon the progress made in patient focused drug development. The more than 30 million Americans and their families impacted by rare disease are counting on us.”
While the Senate has not yet scheduled a vote on Dr. Califf’s nomination, it is likely to occur in early 2022. Dr. Janet Woodcock will continue to serve as Acting FDA Commissioner until Dr. Califf is confirmed by the Senate. “The Foundation greatly appreciates and commends Dr. Janet Woodcock on her decades of service as a steadfast leader for the FDA and the public,” said Annie Kennedy, EveryLife Foundation for Rare Diseases Chief of Policy, Advocacy, and Patient Engagement, “She has led with clarity and vigor during the pandemic, pushed to modernize pharmaceutical manufacturing to increase safety and encourage production in U.S. factories rather than overseas, innovated a paradigm shift in therapeutic development, infrastructure, and stakeholder engagement that has yielded robust development pipelines in disease areas with significant unmet need, and led a full reorganization of the Center for Drug Evaluation and Research, improving the specialization of the drug review divisions. Her work will positively impact the rare disease community for decades to come, and we are grateful. “
