Jessica Benson Cox

Jessica Cox defends pharmaceutical companies, device manufacturers and other industry leaders involved in product liability litigation.

View the full bio for Jessica Benson Cox at the Faegre Drinker website.

Articles by Jessica Benson Cox:


PFAS in Cosmetics Continue to Draw Attention as Litigation and Legislation Efforts Mount

In June 2021, we published Cosmetics Companies: Beware of PFAS, highlighting the recently introduced No PFAS In Cosmetics Act and recommending that cosmetics and personal-care product companies examine their products and supply chains to determine if, when, and where PFAS may affect their businesses. As anticipated, PFAS in cosmetics has continued to draw attention, with the filing of at least two lawsuits and the anticipated enactment of PFAS legislation in several states.

The No PFAS In Cosmetics Act, which seeks to ban the use of intentionally added per- or polyfluoroalkyl substances (“PFAS”) in cosmetics, was introduced in the House on June 17, 2021. The bill has been assigned to the House Energy and Commerce Subcommittee on Health, but no hearing has been scheduled. Ultimately, the bill will require the Department of Health and Human Services to issue and finalize a rule banning the use of intentionally added PFAS in cosmetics. In the meantime, on February 2, 2022, over 30 senators sent a letter to President Biden requesting funding for Fiscal Year 2023 for PFAS research, regulatory efforts, and testing.

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FDA Approves First Interchangeable Biological Product Under BPCIA

On July 28, the FDA approved the country’s first interchangeable biosimilar product. Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with, its reference product Lantus (insulin glargine).

Under the Biologics Price Competition and Innovation Act (BPCIA), biological products (e.g., vaccines and therapeutic antibodies) may come to market by showing that they are “biosimilar” to or “interchangeable” with a “reference product,” which is a biological product that has already been approved by the FDA. A biological product is “biosimilar” if it is “highly similar to the reference product notwithstanding minor differences in clinically inactive components” and “there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.” 42 U.S.C. § 262(i)(2). To date, 28 biological products have been approved as biosimilars.

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FDA Issues Guidance for Applicants Seeking Biosimilar/Interchangeable Approval

The Food and Drug Administration (FDA) released new draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act, intended for prospective applicants of biologics license applications (BLAs) for biosimilar and interchangeable products, and for other parties interested in the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This new guidance aims to further facilitate the development of proposed biosimilar products and proposed interchangeable products.

The BPCI Act created an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product. This newly released draft guidance is the third FDA question-and-answer guidance on the BPCI Act, with the previous two released in December 2018: Questions and Answers on Biosimilar Development and the BPCI Act Guidance for Industry and New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2).

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FDA’s Revocation of the Hydroxychloroquine and Chloroquine EUA May Test the Limits of PREP Act Immunity

On June 15, 2020, the U.S. Food & Drug Administration (FDA) revoked the Emergency Use Authorization (EUA) that permitted emergency distribution of chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ) from the Strategic National Stockpile. (https://www.fda.gov/media/138945/download) The FDA concluded, based on clinical trial data and the continuing failure of treatment guidelines to support use of CQ or HCQ to treat patients with COVID-19, that “it is no longer reasonable to believe that oral formulations of HCQ and CQ may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks.”

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