Having epilepsy myself, I know the U.S. Food and Drug Administration (FDA) plays a critical role in the life and well-being of all Americans. Since serving in the House of Representatives, I have served for many years on the Epilepsy Foundation’s Board of Directors and have always been sensitive to the need for innovative treatments that are both safe and effective.
Therefore, I recognize the significance of the administration’s choice to nominate for commissioner of FDA, and urge it be someone whose experience will allow for a deep understanding of the community of patients and people with disabilities that rely on the FDA heavily for their health and well-being.
{mosads}The FDA’s mandate extends across 25% of our economy — from the food we eat to the medications that improve or save lives every day. We all take medications — whether it be an antibiotic for a sinus infection or an innovative combination of drugs to treat a specific type of cancer. The FDA is a gatekeeper to our health, whether as patients with unmet medical needs or as consumers and medical providers seeking the information they need to make appropriate, mindful decisions about their health. It is vital that the agency find a balance between fostering an environment that encourages and supports innovation and ensuring that the medications, medical devices and diagnostics we are prescribed are safe and effective.
The Epilepsy Foundation supports a strong FDA that is responsive to the needs of the patient community and the innovations of scientific research and health care delivery. The importance of building an FDA that is strong and modernized was reinforced in the 21st Century Cures Act passed last year with strong bipartisan support. It will be crucial for the new FDA Commission to bring the skills and outlook needed to turn the promise of this legislation into reality within the agency.
The epilepsy community, like many others, shares the concern for promoting innovation and bringing new treatments to market in a timeframe that matters. Today, 1 in 26 Americans will develop epilepsy in their lifetime; however, there is no cure, and even with many drugs and treatment options, one third of people with epilepsy live with uncontrollable seizures. Reforms in 21st Century Cures point the way to maintaining the agency’s strong commitment to product safety and effectiveness, while modernizing and keep pace with dramatic changes in medicine and health technology.
We appreciate the delicate balance that the agency is tasked with ensuring that safe and efficacious treatments become available in a timely manner. A new administration can foster new ways to tackle the challenges FDA faces as it strives to bring new treatments to the market, but we cannot lose sight of the unique role the agency plays in ensuring consumers and medical providers can rely on science-based reviews of approved treatments.
For decades, the large majority of FDA commissioners have had medical degrees and a level of education and experience to draw on while serving in this role. This reflects the agency’s charge of reviewing ever more complex drugs and devices, making a strong science background an important consideration for future FDA commissioners. We strongly encourage President Trump to consider a nominee who has the capacity to continue the pave the way for the future at the FDA.
Americans rely on the FDA to conduct the research that they cannot do themselves because we don’t all have the expert, nuanced, intricate scientific knowledge to make choices about what will make us well. Eroding the commitment to effectiveness as part of the treatment review process at the FDA would undermine the agency’s mission. Health care consumers will still want to look to someone for information about effectiveness — who will move to fill the void?
As we move to a more patient-centered approach to health care, the desire for even more effectiveness data is increasing. FDA provides a baseline and we should be striving to find ways to have more, not less, information about the drugs and devices available to us, and ensure that these treatments and information is available to us as soon as possible.
A strong FDA can foster biomedical innovation and also pave the way for greater affordability and access to treatments. New drugs and devices are essential for everyone who is waiting for cures and treatments that can help them and successfully manage medical conditions with less side effect. At a time when we are seeking more individualized treatment options and there is growing concern over drug pricing, FDA’s leader must be able to bring forth meaningful experience with the community of health stakeholders to help Congress determine the resources needed for the agency to bring safe and effective treatments to market faster.
We look forward to continued discussion with all stakeholders committed to a strong FDA that Americans can look to when making important decisions about their health. This is not the place for politics.
Former Rep. Tony Coelho (D-Calif.) is a member of the Epilepsy Foundation board of directors.
The views of contributors are their own and are not the views of The Hill