Posted by July 14, 2014 at 11:33 AM
Written by Keziah Sully, MD. Dr. Sully is a physical medicine and rehabilitation resident at the University of Pennsylvania in Philadelphia, PA and a member of the National Physicians Alliance FDA Task Force.
On June 12th I had the opportunity to make legislative visits in our nation’s capital on behalf of the National Physicians Alliance (NPA). The topics discussed were three federal bills regarding the safe development and production of novel antibiotics. These bills were designed to promote innovation in antibiotic development—a worthy and important goal. However, as drafted, the bills carry a cost in compromised patient safety and transparency. The bills allow for fast track drug approvals by the FDA using alternative endpoints for studies (for example, lab markers rather than patient symptoms), lower standards for efficacy and safety, and worrisome opportunity for financial conflict of interest. My husband, Dr. Yusef Sayeed (also an NPA member), joined me on this endeavor to speak with our congressional leaders in Washington, D.C. and convey the concerns of the NPA.
Initially, I hesitated to lobby as this was new territory for me as a resident physician, but as a prescriber, I know how important drug safety and efficacy are to the welfare of my patients. I know that I need to trust the FDA’s approval processes. Despite my inexperience lobbying, I decided to meet with my elected officials.
To prepare for the meetings, I reviewed the bills we would discuss and NPA background materials. Our FDA taskforce prepared a succinct set of talking points ahead of the meetings, detailing objectives and specifying our concerns. Yusef and I rehearsed the conversations to ready ourselves for the meetings. We anticipated questions they would ask and focused on the clearest way to convey NPA’s concerns and viewpoints. We met with the taskforce for lunch before the meetings to review any last minute questions and pick up some hints and tips from the more seasoned NPA members who have lobbied several times before.
The meetings themselves were far less intimidating than I had anticipated! We met with two legislative assistants within the offices of Senator Robert Casey and Congressman Patrick Meehan. These staffers were gracious, attentive, professional and enthusiastic about speaking with physicians. They asked several questions (a couple of which were not anticipated in our rehearsal) and did not attempt to hurry the agenda. The questions that we were unable to answer gave us a very natural reason to follow up with them in the next few days after discussing it further with the FDA taskforce.
The following day, the American Association for the Advancement of Science hosted a conference with guest speakers including Connecticut Congresswoman Rosa L DeLauro. The conference was insightful and the guest panels were both varied and informative. The structure of the day allowed for lively and powerful discussions from leaders in the field and active members of different professional medical organizations.
Overall, it was an inspiring experience that warmly challenged me as a physician to step out of my comfort zone and explore medicine from a different angle. Perhaps more importantly, taking a more active role helped me put our monthly taskforce meetings into perspective: our efforts to promote conflict-free medicine are appreciated, necessary and make an impact. I would encourage others to challenge yourself in this capacity. You may really surprise yourself with how much you learn and what a difference you can make.