By Lynn L. Bergeson
On March 8, 2019, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., released a statement on the continued efforts to advance safe biotechnology innovations, and the deactivation of an import alert on genetically engineered (GE) salmon. In his statement, Dr. Gottlieb emphasized FDA’s mission to evaluate the safety of intentional genomic alterations (IGA) in animals that will ultimately be sold for consumption in the U.S. According to FDA’s recent framework for the efficient development of safe biotechnology products, Plant and Animal Biotechnology Innovation Action Plan, Dr. Gottlieb stated that FDA has taken important steps to help advance new products.
Part of these efforts includes FDA’s 2015 decision to approve an application related to GE salmon containing the first approved IGA in an animal meant for food consumption. In 2016, however, the U.S. Congress directed FDA not to allow into commerce any food containing GE salmon until it issues final labeling guidelines for informing consumers of the GE salmon content in the food. Consequently, in compliance with Congressional views, FDA implemented an import alert in that same year that prevented GE salmon from entering the U.S. With the enactment of the National Bioengineered Food Disclosure Standard (NBFDS) by Congress, the U.S. Department of Agriculture (USDA) was made responsible for the implementation of a mandatory standard for disclosing foods that are bioengineered. FDA was, therefore, divested of its authority over labeling GE content in human foods. Given the Congressional enactment of NBFDS, Dr. Gottlieb stated that FDA believes this Congressional mandate on GE salmon has been satisfied by USDA’s issuance of final regulations implementing NBFDS. NBFDS requires that human food containing GE salmon be labelled to indicate that it is bioengineered. Therefore, FDA has deactivated the import alert that prevented GE salmon from entering the U.S.
By Lynn L. Bergeson
On November 5, 2018, the U.S. Food and Drug Administration (FDA) announced that a proposed collection of information on the Biosimilars User Fee Program was submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. FDA’s Biosimilars User Fee Program was established under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which amended the Public Health Service Act through the addition of Section 351(k). The BPCI Act also amended the Federal Food, Drug, and Cosmetic Act to include Section 351(k) under human drug applications for prescription drug user fees provisions. The Program is meant to “create an abbreviated approval pathway for biological products shown to be biosimilar to or interchangeable with an FDA-licensed reference biological product. This allows a company to apply for licensure of a biosimilar or interchangeable biological product.” In 2012, the Biosimilar User Fee Act (BsUFA) allowed FDA to assess and collect user fees for activities connected with biosimilar biological product development (BPD). Some of these activities include the submission and review of forms, as well as an annual survey of all BsUFA participants.
The information collection proposal estimates an annual reporting burden of 57 hours, based on the number of respondents, the number of responses per respondent, the total annual responses, and the average burden per response. OMB will be accepting comments on FDA’s collection of information proposal until December 5, 2018.
By Lynn L. Bergeson
On October 30, 2018, the U.S. Food and Drug Administration (FDA) published a statement by FDA Commissioner Scott Gottlieb, M.D., and FDA Deputy Commissioner Anna Abram regarding FDA’s new action plan to advance plant and animal biotechnology innovation. Aimed at ensuring the safety of plant and animal biotechnology products and avoiding unnecessary barriers to future innovation, the Action Plan focuses on three key priorities:
- Advancing public health by promoting innovation;
- Strengthening public outreach and communication; and
- Increasing engagement with domestic and international partners.
The statement includes an indication that FDA will be seeking public input in the coming year. Once input is received, the first step in implementing the new action plan will be the adoption of “a comprehensive policy framework for the development and regulatory oversight of animal biotechnology products, including for intentionally genetically altered animals and the food and drug products derived from them.” According to their statement, this policy framework will be modern and flexible, accompanied by two guidance documents in 2019. The guidance documents are intended to provide greater clarity on how FDA will be applying regulatory oversight in evaluating risk profiles of various products. In addition to these elements, the Action Plan also highlights FDA’s commitment to efforts with both national and international partners in fostering efficiency and cooperation.
By Lynn L. Bergeson
On June 21, 2018, the U.S. Food and Drug Administration (FDA) announced it was withdrawing the draft guidance, “Statistical Approaches to Evaluate Analytical Similarity,” issued in September 2017. The announcement states that the draft guidance, if issued in final as written, “was intended to provide advice for sponsors developing biosimilar products regarding the evaluation of analytical similarity between a proposed biosimilar product and the reference product.” Further, comments submitted to the docket “addressed a range of issues that could impact the cost and efficiency of biosimilar development, including the number of reference product lots the draft guidance would recommend biosimilar developers sample in their evaluation of high similarity and the statistical methods for this evaluation.” FDA states that after considering the public comments that were received on the draft guidance, it determined it would withdraw the draft guidance as it gives further consideration to the scientific and regulatory issues involved, and that it intends to “issue future draft guidance that will reflect state-of-the-art techniques in the evaluation of analytical data to support a demonstration that a proposed biosimilar product is highly similar to a reference product.” FDA will communicate publicly when new draft guidance is issued.
By Lauren M. Graham, Ph.D.
On October 12, 2017, the U.S. Food and Drug Administration (FDA) announced two public meetings regarding its Agricultural Biotechnology Education and Outreach Initiative. The meetings will be held in Charlotte, North Carolina, on November 7, 2017, from 8:00 a.m. to 1:00 p.m. (EST) and in San Francisco, California, on November 14, 2017, from 8:00 a.m. to 1:00 p.m. (PST). FDA states the purpose of the public meetings is “to provide the public with an opportunity to share information, experiences, and suggestions to help inform the development of this education and outreach initiative.” This initiative, which Congress appropriated $3 million to fund, calls upon FDA to work with USDA to provide education and outreach to the public on agricultural biotechnology and food and animal feed ingredients derived from biotechnology. More information on the initiative and information on how to register for the meetings is available on FDA’s website. Comments on questions listed in the Federal Register notice, scheduled to be published tomorrow, are also being requested and can be filed in Docket FDA-2017-N-5991 on www.regulations.gov. Comments are due by November 17, 2017.
By Lynn L. Bergeson and Margaret R. Graham
On June 30, 3017, the National Academies of Sciences, Engineering, and Medicine (NAS) released its final version of its report Preparing for Future Products of Biotechnology, which it states “analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making [and] … identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.” This report is a collaboration among a committee of experts including the Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System (Committee), the Board on Life Sciences, the Board on Agriculture and Natural Resources, the Board on Chemical Sciences and Technology, and the Division on Earth and Life Studies and sponsored by the U.S. Environmental Protection Agency (EPA), the U.S. Department of Agriculture (USDA), and the U.S. Food and Drug Administration (FDA). Lynn L. Bergeson was an external contributor to the Committee’s deliberations and presented before the Committee on the subject of the biotechnology regulatory system.
The report includes sections on emerging trends and products of biotechnology; the current biotechnology regulatory system; understanding risks related to future biotechnology products; opportunities to enhance the capabilities of the biotechnology regulatory system; and an index on congressionally defined product categories that FDA regulates; as well as conclusions and recommendations that were included in our blog item on the prepublication version.
More information on the regulatory issues of biotechnology products is available on our biobased products blog under key word biotechnology, as well as the Bergeson & Campbell, P.C. (B&C®) regulatory developments website under key phrase biobased products, biotechnology.
On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology. The 2017 Update provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) with respect to regulating biotechnology products. Together with the National Strategy for Modernizing the Regulatory System for Biotechnology Products, published in September 2016, the 2017 Update offers a “complete picture of a robust and flexible regulatory structure that provides appropriate oversight for all products of modern biotechnology.” Within that regulatory structure, the federal agencies “maintain high standards that, based on the best available science, protect health and the environment, while also establishing transparent, coordinated, predictable and efficient regulatory practices.” More information is available in Bergeson & Campbell, P.C.’s (B&C®) memorandum White House Announces Release of Final Update to the Coordinated Framework for the Regulation of Biotechnology.
By Lynn L. Bergeson and Carla N. Hutton
On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology (2017 Update). The Update to the Coordinated Framework provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) with respect to regulating biotechnology products. Together with the National Strategy for Modernizing the Regulatory System for Biotechnology Products, published in September 2016, the Update to the Coordinated Framework offers a “complete picture of a robust and flexible regulatory structure that provides appropriate oversight for all products of modern biotechnology.” Within that regulatory structure, the federal agencies “maintain high standards that, based on the best available science, protect health and the environment, while also establishing transparent, coordinated, predictable and efficient regulatory practices.” To help product developers and the public understand what the regulatory pathway for products might look like, the 2017 Update presents information about agency roles and responsibilities in several forms, including:
- Graphics that illustrate agency-specific overviews of regulatory roles;
- Case studies that demonstrate how a product developer might navigate the regulatory framework; and
- A comprehensive table that summarizes the current responsibilities and the relevant coordination across EPA, FDA, and USDA for the regulatory oversight of an array of biotechnology product areas.
In its blog item, “Increasing the Transparency, Coordination, and Predictability of the Biotechnology Regulatory System,” the Obama Administration acknowledges that while the 2017 Update represents “remarkable progress by the EPA, FDA, and USDA to modernize the regulatory system for biotechnology products, much work remains.” EPA, FDA, and USDA will consider the comments submitted in response to the proposed 2017 Update and information gathered during the three public engagement sessions hosted by EPA, FDA, and USDA to inform ongoing and future agency activities. In addition, the agencies commissioned an independent study by the National Academy of Sciences (NAS) on future biotechnology products. When completed, the agencies will consider the study’s findings, as well as the comments. More information on the Update to the Coordinated Framework will be available in our forthcoming memorandum, which will be available on our website under the key phrase biobased products, biotechnology.
On September 22, 2016, Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology (Update to the Coordinated Framework) was published in the Federal Register . This proposed update provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and U.S. Department of Agriculture (USDA) with respect to the regulation of biotechnology products. More information about what this means for the future of biotechnology and the biotechnology industry is available in the Bergeson & Campbell, P.C. (B&C®) memorandum "Biotechnology: White House Releases Proposed Update to the Coordinated Framework and National Strategy for Modernizing the Regulatory System for Biotechnology Products." Comments are due by November 1, 2016 , at 5:00 p.m. (EDT).