By 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...
Category: FDA
March 6, 2020
Guidance On Biological Product Transition Issued By FDA
By 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...
By 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...
February 28, 2020
FDA Upgrades Its Database Of Licensed Biological Products
By Lynn L. Bergeson On February 24, 2020, FDA Commissioner Stephen M. Hahn, M.D., announced that FDA is upgrading its Purple Book, which is otherwise known as its “Database of FDA-Licensed Biological Products.” According to Dr. Hahn, FDA is working to expand the Purple Book by transitioning from its current list format to a searchable online database for all approved biosimilar products and their reference products. An upgrade planned to be released in multiple phases, the full...
February 28, 2020
FDA Issues Final Rule Amending The Definition Of “Biological Product”
By Lynn L. Bergeson On February 21, 2020, the U.S. Food and Drug Administration (FDA) issued a final rule to amend its regulation that defines “biological product.” The new definition incorporates changes made by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) and the Further Consolidated Appropriations Act, 2020 (FCA Act). Under the final rule, the statutory term “protein” is interpreted to mean any alpha amino acid polymer with a specific, defined...
February 7, 2020
FDA/FTC To Host Public Workshop On Biosimilars’ Competitive Market
By Lynn L. Bergeson On March 9, 2020, the U.S. Food and Drug Administration (FDA), in collaboration with the Federal Trade Commission (FTC), will host a public workshop titled “FDA/FTC Workshop on a Competitive Marketplace for Biosimilars.” The focus of the workshop will be on FDA and FTC’s collaborative efforts to support appropriate adoption of biosimilars, deter anticompetitive behaviors in the biologic marketplace, and discourage false or misleading statements about...
January 31, 2020
Biofuel Supply Chain Stakeholders Create Strategy For Liquid Fuels
By Lynn L. Bergeson On January 22, 2020, three trade associations announced the launch of a strategy to tackle the transition into 100 percent biofuels for heating oil in English and Irish homes. A United Kingdom (UK) based trade association, the Oil Firing Technical Association (OFTEC) has partnered with the Tank Storage Association (TSA) and the UK and Ireland Fuel Distributors Association (UKIFDA) to launch a future vision for liquid fuels, titled “Supply Chain Strategy for Liquid...
January 28, 2020
Senate Refers Sustainable Chemistry Research and Development Act of 2019 to Committee on Commerce, Science, and Transportation
On December 10, 2019, the U.S. Senate received and read twice the Sustainable Chemistry Research and Development Act of 2019 (Act). Passed by the U.S. House of Representatives one day prior to the Senate’s review, the Act -- H.R. 2051 -- if approved, will establish an interagency working group led by the Office of Science and Technology Policy (OSTP) to coordinate federal programs and activities in support of sustainable chemistry. This is an exciting development and, for sustainable...
January 14, 2020
New Joint Website on Agricultural Biotechnology Products Launched by EPA, USDA, and FDA
On January 9, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) announced the launch of a new website created in coordination with the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) that provides information about actions the federal government is taking to oversee the development of agricultural biotechnology products. This “one-stop-shop” website was created under the direction of Executive Order...
January 10, 2020
USDA, FDA, And EPA Announce Unified Website On Biotechnology
By Lynn L. Bergeson On January 9, 2020, also in recognition of National Biotechnology Month, the U.S. Department of Agriculture (USDA), the U.S. Food and Drug Administration (FDA), and the U.S. Environmental Protection Agency (EPA) announced the launch of a unified website for biotechnology regulation. Streamlining information about the three agencies in charge of overseeing agriculture biotechnology products, this website comes, in part, to fulfill President Trump’s Executive Order (EO)...