Biobased Products News and Policy Report
April 17, 2020
FDA Requests Comments On Product User Fee Programs
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.
DOE STEAB Virtual Meeting Announced
On May 6, 2020, the U.S. Department of Energy’s (DOE) Office of Energy Efficiency and Renewable Energy (EERE) will host a virtual meeting of the State Energy Advisory Board (STEAB). The virtual meeting will take place from 12:00 p.m. to 4:00 p.m. (EDT). Interested parties must contact the Board’s Designated Federal Officer, Jay Nathwani, via e-mail or phone at 202-586-9410.
EPA Publishes Updated Data On TSCA CBI Reviews
On April 10, 2020, the U.S. Environmental Protection Agency (EPA) published a quarterly update of the Toxic Substances Control Act (TSCA) confidential business information (CBI) review statistics. The data summarize the number of CBI cases under review and results of completed reviews through March 1, 2020. In addition, a spreadsheet showing the details of completed TSCA CBI determinations through March 1, 2020, is available. EPA states that making this information publicly available “continues to demonstrate the agency’s commitment to transparency while fulfilling its responsibilities under the Lautenberg Act amendments to TSCA.” According to EPA, it has established “numerous new processes, systems, and procedures to enable submitters to provide the information required when making confidentiality claims and to facilitate EPA’s review, and where applicable, determinations on these claims.” The updated statistics show EPA’s progress toward meeting these requirements.
EC Launches Initiative Aimed At Connecting Stakeholders With Biobased Compounds
On April 10, 2020, the European Commission (EC) announced the launch of its new online service that connects crop and food producers with biorefineries. This European Union (EU) project aims to address food waste by enabling crop producers, food processors, and agricultural cooperatives to sell their waste as feedstock for use by two biorefineries in Spain and Italy. The multi-feedstock biorefineries, designed by Agrimax, convert farming and food processing byproducts into compounds that can be used in biobased food packaging as well as in the biobased chemical and agricultural sectors. Agrimax is an EU-funded project focused on the development and demonstration of high-value products from crop and food-processing waste. Its work develops economically competitive routes to the commercialization of the products. The project is expected to end in September 2020; developers hope to make a positive impact in growth of the biobased and agricultural sectors.
USDA Report States That Brexit Will Not Change Policies Affecting GE Plants
On April 9, 2020, the U.S. Department of Agriculture (USDA) published a report titled “Agricultural Biotechnology Annual,” which argues that under any scenario, the United Kingdom’s (U.K.) separation from the EU (Brexit) is unlikely to change policy or trade in genetically engineered (GE) industries. According to the report prepared by USDA’s Jennifer Wilson, given the fact that the EU is the U.K.’s trading partner and has been for many years, the U.K. will retain much of the EU’s food laws in the short to medium term. Although Brexit could potentially change the agricultural biotechnology policy arena, it is not clear yet whether the U.K. will deviate from the European Court of Justice ruling on New Plant Breeding Techniques. Overall, according to Wilson’s summary, it seems that senior U.K. politicians favor simple genome editing techniques. In addition, it would be unlikely that large multinational seed technology companies would invest in commercialization of a GE crop that could only be marketed in the U.K., which is part of the reason that the current landscape for the cultivation and importation of GE products is not expected to change.