FDA announces major regulatory overhaul initiative

Changes will impact tens of thousands of FDA-regulated entities worldwide – top points and action steps

FDA Alert


In a major announcement, the FDA has started a process aimed at making significant and widespread changes to its regulations that will affect tens of thousands of businesses worldwide.

On September 7, 2017, FDA announced the opening of multiple public dockets to receive comments from interested stakeholders on:

"ways to modernize [FDA] regulations…. not only looking at what new regulations or policies we need in order to be most effective in fulfilling our public health responsibilities [but] also taking a closer look to see if we need to revise, update, and in some cases eliminate existing regulations to help us better keep pace with scientific advancement and the people that we serve." 

This initiative is part of President Donald Trump's agenda of regulatory reform. It will be a massive undertaking given the breadth of FDA's regulatory authority over a vast array of products and industries, including food, pharmaceuticals, medical devices, biotechnology, tobacco, clinical research organizations, dietary supplements, cosmetics, veterinary products and even lasers. Thus, the changes to FDA regulations that may come out of this initiative could impact tens of thousands of companies in those industries worldwide.

If you are involved in any FDA-regulated industry, you cannot afford to ignore this proceeding.  It will be imperative to become familiar with the initiative, the governmental and political philosophies that are motivating it and that will shape its outcomes, and, more importantly, how the result of these efforts have the potential to harm, or help, your business interests in both the short and long terms. Prudent businesses are already planning to make their  views and specific regulatory proposals heard in this proceeding. 

FDA's announcement of the initiative, along with links to the Federal Register notices of this initiative for each of the industry sectors FDA regulates can be viewed here. DLA Piper's FDA and Medical Products Regulatory group and its Government Affairs Law and Policy group have the vast experience to assist in assessing your regulatory risks and opportunities under this initiative, help you develop your strategic proposals, and effectively communicate and advocate for those positions in this FDA proceeding and through other channels.  

For more information, or to discuss strategic concerns,  please contact the relevant DLA Piper attorney below:

James N. Czaban, Chair, FDA and Medical Products Regulatory group, for pharmaceutical, biotechnology or general FDA regulatory issues

Stefanie Fogel (Co-Chair, Food and Beverage Sector), for food, dietary supplement, or cosmetic issues

Rebecca Jones McKnight, for medical device and diagnostic issues and other regulatory issues across the Life Sciences sector 

George M .Karavetsos, for FDA enforcement and compliance issues

Steven R. Phillips (Co-Chair, Federal Law and Policy group) for legislative and political advocacy issues