By Benjamin Policicchio, PhD and Suzanne M. Sensabaugh, MS, MBA

In 2017, a joint effort between the U.S. Food and Drug Administration (FDA), U.S. Environmental Protection Agency (EPA), and the U.S. Department of Agriculture (USDA) produced the “2017 Update to the Coordinated Framework for the Regulation of Biotechnology.” This update represents a sequel to the 1986 Coordinated Framework for the Regulation of Biotechnology and the 1992 Update of the Coordinated Framework and is intended to clarify the current roles and responsibilities of the three above primary agencies involved in the regulation of biotechnology products, to develop a long-term strategy to ensure that the Federal biotechnology system is prepared for the future products of biotechnology, and to commission an expert analysis of the future landscape of biotechnology products to support these efforts. The below blog post is part 1 of 4 discussing this update. This post will detail the background necessary to understand this update.

As we are all aware, the landscape of biotechnology and biologics is rapidly changing with new advances in the science and technology, altering how the government regulates such products. Further, the complexity of the current regulatory is not conducive to a general public understanding of the regulation of biotechnology products and creates challenges for small and mid-sized businesses navigating the regulatory process for these products. The first Coordinated Framework was released in 1986 and explained the proper allocation and coordination of oversight responsibilities among relevant Federal agencies, including the FDA, EPA, and USDA. It was noted that this Framework was “expected to evolve in accord with the experiences of the industry and agencies…”

As such, the 1992 Update to the Coordinated Framework was released and described a risk-based, scientifically sound basis for the oversight of activities that introduce biotechnology products into the environment. Based on the original Coordinated Framework and the 1992 update, the FDA, EPA, and USDA have developed their own agency-specific regulations, rules, and policy documents and updated them as necessary.

Since the 1992 update, advances in science and technology have resulted in the development of products not previously possible. As such, an update to the aforementioned Coordinated Framework documents was necessary to facilitate appropriate Federal oversight by the regulatory agencies. On July 2, 2015, the Executive Office of the President (EOP) issued a memorandum to the FDA, EPA, and USDA to update the Coordinated Framework. The memorandum established a Biotechnology Working Group with representatives from the EOP, FDA, EPA, and USDA to implement the tasks in the memorandum. The memorandum stated that the following four objectives be accomplished:

  • clarifying which biotechnology product areas are within the authority and responsibility of each agency
  • clarifying the roles that each agency plays for different product areas, particularly for those product areas that fall within the responsibility of multiple agencies, and how those roles relate to each other in the course of a regulatory assessment
  • clarifying a standard mechanism for communication and, as appropriate, coordination among agencies, while they perform their respective regulatory functions, and for identifying agency designees responsible for this coordination functions; and
  • clarifying the mechanisms and timeline for regularly reviewing, and updating as appropriate, the Coordinated Framework to minimize delays, support innovation, protect health and the environment and promote the public trust in the regulatory systems for biotechnology products.

Over the next three posts, we will discuss the above four objectives and how they were accomplished in the 2017 Update to the Coordinated Framework.

Suzanne M. Sensabaugh

Suzanne M. Sensabaugh is President and Principal Consultant of Hartmann Willner, where she is a regulatory affairs consultant who provides professional advice to clients.