A new Regulatory Era

By: Edward Allera
Chairman of The 505(b)(2) Platform
The other week a I had the opportunity to attend the Reagan-Udall-FDA Foundation (“RUF”) Annual Meeting in Washington.  It was a unique experience for me in my over 40+ years of working the Food and Drug Administration. Perhaps RUF’s Congressionally established relationship provided that special atmosphere. New Principal Deputy Commissioner, Dr. Amy Abernathy, led off with an impassioned introduction about the Agency and its desire to implement new technology to achieve its public health mission. As a physician with academic, medical and high-tech expertise, Dr. Abernathy set the stage for a candid and impassioned discussion by the Center Directors for the audience of patient advocates and regulated industry representatives.
A round-table informal conversation atmosphere existed among the Directors.  It was like a heart-to-heart discussion about therapeutic options you would have with your own physician.  Each Director spoke thoughtfully about the issues they face with providing better health care to the public.  They discussed how they consider issues and try to balance the needs of the patients with their concerns as healthcare practitioners.  It was a physician-patient dialogue about improving the public health where the leaders displayed their love for their jobs which is wrapped into the desire to listen to patients and to learn from their needs.
Because FDA has seen so many things go badly over its long history, it has often been seen as paternalistic and arrogant, but this forum revealed a different perspective. We are in a new regulatory era driven by new technologies, social media, and decades of investment that have produced enlightenment from the top down.  Bipartisan Congressional support for RUF has been invaluable in creating this environment.  Regardless of the genesis, the concluding dialogue between RUF Chairwoman Ellen Sigal and Acting Commissioner Ned Sharpless confirmed that the nurturing regulatory environment for patients will continue. The concerns for patients and the need to provide them with the best treatments as soon as safely possible was clearly communicated and profound.
This meeting showed me the singular relationship that Congress created between RUF and FDA has provided a unique forum for the Agency to articulate its procedures, passion for its mission and the public as well as its desire to improve its ability to help all. 
​As we move The 505(b)(2) Platform forward we will strive to assist the FDA in their understanding of the challenges for 505(b)(2) sponsors.  That is why our first initiative is to assist the FDA by helping to improve current guidance and identify the needs for new guidance.  You can help us by letting us know any guidance that you have difficulty with or areas where you think there could be more guidance. Send your comments and thoughts to us at meetings@505b2.org