On September 16, the United States federal government released a statement on their progress in modernizing and clarifying the regulatory process for biotech products. They are in the process of coordinating with the EPA, FDA, and the USDA, taking into account the results of the NAS Biotech Study, and considering public comments in order to develop a biotech regulatory process that ensures safe products while allowing businesses built around these products to flourish. However, the two documents released alongside the statement do a great job of clarifying the current and future state of regulations and are documents any investor or entrepreneur in the biotech space should make themselves familiar with:
This document details the government's plans for how the three federal regulatory agencies will update their regulatory systems with a focus on transparency, predictability, and efficiency. It contains specific details concerning the studies, meetings, and workshops that each of the agencies have held in order to gain information on the best ways to proceed. Of more interest to entrepreneurs, this document contains links to resources for small businesses that these agencies have made available, like the FDA’s Small Business Guide or the USDA’s Am I Regulated process. In addition, there are also notes on how the agencies are attempting to adjust to the radical new technologies that are emerging and information on future meetings for parties that wish to influence the process.
In order to help businesses understand the regulatory process that their products are subject to, the White House Office of Science and Technology Policy issued the Coordinated Framework for the Regulation of Biotechnology in 1986 and updated it in 1992. The newest update gives companies an overview of the current landscape and acts as a cheat sheet for understanding the regulatory hurdles required for product approval. It contains useful charts that detail which agencies and which programs govern the regulation of every type of biotech product, from therapeutics to food to industrial chemicals. It also includes case studies of different biotech products, so that business can gain a greater understanding of the regulatory path their product will take. Both entrepreneurs and investors should have a copy readily available for review.
Though the regulatory landscape around biotech products is still in flux, these documents released in this announcement go a long way towards clarifying the current and future regulations. In addition to learning about what the agencies are looking for, interested parties are still able to leave comments in order to assist the government in creating a regulatory process that is efficient and scientifically-driven.