Posted on May 03, 2023 by Lynn L BergesonBy Lynn L. Bergeson and Carla N. Hutton
On April 25, 2023, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced that it published a new five-year strategic plan. According to APHIS, it incorporates input it received from stakeholders on the strategic framework, a summarized version of the plan that it published in June 2022. The plan includes six strategic goals that focus on working to:
- Protect agriculture from plant and animal diseases and pests. Objective 5 is “Ensure the development of safe agricultural biotechnology products using a science-based regulatory framework.” This includes:
- Conducting efficient risk-based permit review and issuance for organisms developed using genetic engineering to ensure they are safely contained or confined during movement or release;
- Using plain language to communicate clearly APHIS regulations, expectations, and guidance to stakeholders, particularly those working with modified non-plant organisms potentially subject to APHIS regulations; helping stakeholders understand regulations through outreach, workshops, toolkits, and other means; and
- Working with the U.S. Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA) to increase coordination and harmonization of regulatory oversight for biotechnology products within each agency’s existing statutory framework;
- Cultivate a talented, diverse, and public service-focused workforce where employees are supported, valued, and engaged;
- Reduce the impacts of zoonotic and emerging diseases and climate change. Objective 3 is “Mitigate and adapt to the effects of climate change.” This includes:
- Incorporating climate change scenarios when evaluating the plant pest risk associated with biotechnology products; and
- Working with federal partners to develop clear, efficient, predictable, and risk-based regulatory pathways for safely bringing microbial and other new products that help address climate change to market, and helping developers of such products navigate the regulatory system;
- Maintain and expand the safe trade of agricultural products nationally and internationally. Objective 2, “Maintain and expand the Agency’s leadership role through international standard setting and collaboration,” includes promoting engagement, collaboration, and harmonization of agricultural biotechnology regulation with trading partners, the Organization for Economic Cooperation and Development (OECD), and other international and regional organizations. Objective 3, “Create safe export opportunities,” includes:
- Communicating to international stakeholders about APHIS’ processes and share outcomes of biotechnology product evaluations;
- Working with trade agencies on technical aspects of trade in biotechnology products; and
- Working with the regulatory authorities of U.S. trading partners to harmonize further regulatory frameworks for biotechnology products;
- Manage wildlife damage and threats to agriculture, natural resources, property, and people; and
- Promote the welfare of animals.
Posted on September 28, 2021 by Lynn L BergesonBy Lynn L. Bergeson
On September 20, 2021, the U.S. Food and Drug Administration (FDA) announced the availability of its revised final guidance for industry on biosimilar development and the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). Titled “Questions and Answers on Biosimilar Development and the BPCI Act,” the revised guidance aims to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable biosimilars. The guidance also includes FDA’s interpretation of certain statutory requirements added by the BPCI Act.
Posted on November 06, 2020 by Lynn L BergesonBy Lynn L. Bergeson
On October 30, 2020, the U.S. Food and Drug Administration (FDA) announced that it will host a virtual public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years 2023 through 2027. Under BsUFA, FDA collects user fees to support its process for the review of biosimilar and biological products and the current legislative authority is set to expire in September 2022. At the aforementioned time, new legislation will be required for FDA to continue collecting user fees in future fiscal years. FDA requests public comments as it begins the process to reauthorize the BsUFA program and invites stakeholders to participate in its virtual public meeting on November 19, 2020, from 9:00 a.m. to 12:30 p.m. (EST). Registration to participate in the virtual meeting is available here. After the meeting, written comments must be submitted on or prior to December 19, 2020.
Posted on August 07, 2020 by Lynn L BergesonBy Lynn L. Bergeson
On August 4, 2020, the U.S. Food and Drug Administration (FDA) Department of Health and Human Services (DHHS) announced the rates for biosimilar user fees for fiscal year (FY) 2021. The fees assessed are used by FDA for certain activities in connection with biosimilar biological product development, review of applications for approval of biosimilar biological products, and approval of product applications. The established fees will apply from October 1, 2020, through September 30, 2021.
Posted on June 05, 2020 by Lynn L BergesonBy Lynn L. Bergeson
On June 30, 2020, from 9:00 a.m. to 5:30 p.m. (EDT),the U.S. Food and Drug Administration (FDA) will host a free regulatory training for industry on bioanalysis requirements and expectations. Focused on how FDA’s Center for Drug Evaluation and Research (CDER) approaches various issues in bioanalysis, the workshop aims to provide participants with a better understanding of how FDA performs bioanalysis. Topics to be covered, among others, include:
- Bioanalytical method validation: history, process, and regulatory perspectives;
- Biosimilars;
- Regulated bioanalysis for large molecules;
- Regulated bioanalysis for small molecules;
- Drugs and biologics;
- Bioanalysis of unstable analysis;
- Repeat analysis; and
- A case study on bioanalytical approaches to mitigate issues identified during bioequivalence clinical site inspection.
Registration is required.
Posted on May 15, 2020 by Lynn L BergesonBy Lynn L. Bergeson
On May 12, 2020, the U.S. Food and Drug Administration (FDA) announced the release of an update to its Purple Book: Database of FDA-Licensed Biological Products (Purple Book). The update adds all FDA-licensed biological products, including products approved in the new drug applications (NDAs) that were deemed to be licenses (transition biological products). This update also includes a new feature allowing users to download reports. Historical reports now include highlighted sections reflecting changes made in the previous month. This is the second phase of FDA’s Purple Book planned improvements.
As reported in B&C’s biobased products blog on February 28, 2020, FDA is working to expand the Purple Book by transitioning from its current table list format to a searchable online database for all approved biosimilar products and their reference products. The first phase of the upgrade included information about a product’s proprietary and proper names, the full product label, dosage form, route of administration, strength, and marketing status, among other information. Subsequent phases will include the expansion of the number of FDA-licensed biological products included in the Purple Book online database until the final release, which will include information about all FDA-licensed biological products.
Posted on April 17, 2020 by Lynn L BergesonBy Lynn L. Bergeson and Ligia Duarte Botelho, M.A.
On April 6, 2020, the U.S. Food and Drug Administration (FDA) published a report that provides options and recommendations for a new methodology to evaluate changes in resource capacity needs of human drug and biosimilar biologic review programs. Titled “Independent Evaluation of the PDUFA and BsUFA Resource Capacity Planning Adjustment Methodology: Evaluation and Recommendations,” the analysis of the methodology was reviewed by an outside consultant, contracted by FDA. The report summarizes the evaluation of FDA’s proposed capacity planning adjustment methodology to calculate the annual fees for human drugs and biosimilar biologics under the FDA Reauthorization Act of 2017. According to the report’s executive summary, “[t]he report examines the options and recommendations for the proposed capacity adjustment methodology to accurately assess changes in the resource and capacity needs for prescription drug and biologic biosimilar fee direct review work.” Relevant to those interested in developing, and streamlining such products, as part of the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) and Biosimilar User Fee Amendments of 2017 (BsUFA II) commitments, FDA is developing this methodology to improve its user fee resources. Comments will be accepted until May 6, 2020.
Posted on March 06, 2020 by Lynn L BergesonBy Lynn L. Bergeson and Ligia Duarte Botelho, M.A.
On March 4, 2020, the U.S. Food and Drug Administration (FDA), in collaboration with EPA and the U.S. Department of Agriculture (USDA), launched a new initiative called “Feed Your Mind” to help consumers better understand genetically engineered (GE) foods. Consisting of science-based information, the initiative’s features include a wide range of resources designed to teach consumers, health care professionals, and students about what a genetically modified organism (GMO) is, how GMOs are created and grown, the types of crops that can be GE, and to address questions about the health and safety of GMOs. “Feed Your Mind” also includes an explanation of how GMOs are regulated in the United States. Materials available through the initiative include new web content, videos, graphics, fact sheets, and stories, which include historical information on GMOs in agriculture. The initiative is launching in phases, and FDA expects that more resources will become available later in 2020 and 2021, including professional learning series for dietitians and a supplemental science curriculum for high schools. According to the three agencies, the materials available are based on extensive formative research after input from stakeholders and experts in biotechnology, education, and communications.
Posted on March 06, 2020 by Lynn L BergesonBy Lynn L. Bergeson and Ligia Duarte Botelho, M.A.
On March 4, 2020, FDA announced that it has issued in final a guidance for industry titled “The ‘Deemed to be a License’ Provision of the BPCI Act: Questions and Answers,” which addresses FDA’s “transition” provision of the BPCI Act. Established in 2009, the Biologics Price Competition and Innovation Act (BPCI Act) deemed applications for an approved biological product under Section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to be a license for the biological product under Section 351 of the Public Health Service Act (PHS Act) as of March 23, 2020. Aiming to make the BPCI Act implementation process smoother, FDA has published the guidance for industry as part of the “transition” provision of the Act. The transition of biological products currently regulated under the FD&C Act to the PHS Act will allow for the submission and approval of marketing applications for new biosimilar or interchangeable biological products. The guidance follows FDA’s recent issue of the new definition of the term “biological product,” announced on February 21, 2020, per Bergeson & Campbell, P.C.’s (B&C®) February 28, 2020, blog item.
Posted on March 06, 2020 by Lynn L BergesonBy Lynn L. Bergeson and Ligia Duarte Botelho, M.A.
On March 5, 2020, FDA opened a public docket for comments on its enhancement of the Purple Book, which is otherwise known as FDA’s “Database of FDA-Licensed Biological Products.” As reported in B&C’s biobased products blog on February 28, 2020, FDA is working to expand the Purple Book by transitioning from its current table list format to a searchable online database for all approved biosimilar products and their reference products. These upgrades will be released in multiple phases. FDA has now completed phase I, which consists of the full search functionality of the database. Subsequent phases will include the expansion of the number of FDA-licensed biological products included in the Purple Book online database until the final release, which will include information about all FDA-licensed biological products.
The first phase of the upgrade includes information about a product’s proprietary and proper names, the full product label, dosage form, route of administration, strength, and marketing status, among other information. Given its completion, FDA is now requesting comments from stakeholders until May 4, 2020.
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