Biotechnology and Biologic Products Regulation: Food and Drug Law Book 6 of 12

by Roseann B. Termini, Esq.

Overview

The dire necessity for vaccine therapies became apparent with the COVID-19 pandemic that commenced in early 2020. Initially, former FDA Commissioner Hahn emphasized at the time of the pandemic there were no FDA-approved therapeutics or drugs to treat, cure or prevent COVID-19; however, there are now approved and authorized vaccines to combat this virus as well as treatments such as Remdesivir, an antiviral drug used for Ebola manufactured by Gilead Sciences, Inc. which was approved to treat COVID-19. Yet, the COVID-19 pandemic has proved tenacious with well over 825,000 deaths at the start of 2022 in the United States alone. Leading vaccines to prevent COVID-19 include emergency authorizations to Pfizer-BioNTech, Moderna and Johnson & Johnson.
Biologics including bioengineered or "biotech" therapies have proliferated the marketplace. The authority of the Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) stems from the Public Health Services Act (PHSA) and specific sections of the United States Food, Drug and Cosmetic Act (FDCA). Critical parameters in the regulation of these products remains science based to assure purity, potency, safety, efficacy, and availability. Biologics result from living sources such as humans, animals and microorganisms. They are unlike conventional drugs, which are chemically synthesized. Biologics involve complicated mixtures and are produced using biotechnology. Biologics include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or living entities such as cells and tissues. Generic versions of biotech drugs referred to as biosimilars or follow-on biologics present an interesting and complex issue for both industry and FDA. Increased competition, naming, high costs, transition to the PHSA licensing and attempts to stymie the market by brand companies.
The United States Supreme Court pronouncement in Association for Molecular Pathology v. Myriad Genetics, hinged on whether naturally occurring human genes and/or isolating those genes from the body were a patentable invention. As the biosimilar market increases, issues concerning these products continue. Increased competition, naming, high costs, transition to the PHSA licensing and attempts to stymie the market by brand companies. The United States Supreme Court settled the issue of notice of commercial marketing in Sandoz, Inc. v. Amgen Inc.
Biosimilars have become a multibillion-dollar market and in fact, one of the most expensive medicines in the world is a gene therapy drug approved whose cost is two million dollars. Congress passed the Biologics Price Competition and Innovation Act (BPCI or Biosimilars) Act, in Title VII of the 2010 Patient Protection and Affordable Care Act, Pub.L. 111-148, amended by the Health Care and Reconciliation Act of 2010 (Healthcare Reform Act). The BPCI Act established a 12-year exclusivity period before biosimilars can be approved for marketing in the United States. FDA approved the first biosimilar in 2015 and continues to do so throughout the ensuing years. In 2021, the Advancing Education on Biosimilars Act was passed whose aim is to improve federal initiatives to educate patients, doctors and caregivers about biosimilar drugs. Finally, FDA approved the first-ever interchangeable biosimilar in 2021.Biologics including bioengineered or "biotech" therapies have proliferated the marketplace. The authority of the Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) stems from the Public Health Services Act (PHSA) and specific sections of the United States Food, Drug and Cosmetic Act (FDCA). Critical parameters in the regulation of these products remains science based to assure purity, potency, safety, efficacy, and availability. Biologics result from living sources such as humans, animals and microorganisms. They are unlike conventional drugs, which are chemically synthesized. Biologics involve complicated mixtures and are produced using biotechnology. Biologics include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or living entities such as cells and tissues. Generic versions of biotech drugs referred to as biosimilars or follow-on biologics present an interesting and complex issue for both industry and FDA. Increased competition, naming, high costs, transition to the PHSA licensing and attempts to stymie the market by brand companies.

Product Details

BN ID:	2940160996899
Publisher:	Forti Publications
Publication date:	01/08/2022
Series:	Food and Drug Law , #6
Sold by:	Barnes & Noble
Format:	eBook
File size:	249 KB

About the Author

Roseann B. Termini, B.S., Ed. M., J.D. has over thirty years of extensive experience in food and drug law. This volume, which is also contained in the new print sixth edition, emanateS from her comprehensive food and drug regulatory law books. Ms. Termini has frequently presented food and drug law topics as a featured speaker. Further, she has published a broad array of specialized food and drug law issues such as corporate accountability, criminal liability, enforcement, health claims, supplements, safety, duty to warn, preemption, regulation, promotion, tobacco, stem cells, risk assessment and globalization. She was the first recipient of the Plain English Award by the Pennsylvania Bar Association. Her expertise includes an appellate clerkship, position as sole corporate counsel, regulatory attorney and senior deputy attorney general at the Pennsylvania Office of Attorney General (OAG). While at the OAG, she prosecuted cases at the trial and appellate levels and was in charge of implementation procedures for the Pennsylvania Plain Language Act. Ms. Termini designed and developed the inaugural online food and drug law courses at Widener University School of Law, Johns Hopkins University, the University of Georgia, Drexel Uni-versity and a direct to consumer promotion course at St. Joseph’s University’s Executive Program. Ms. Termini has also taught food and drug law courses at Temple University’s Quality and Regulatory Affairs Graduate Program and Penn State-Dickinson School of Law. Ms. Termini has been active on the com-mittees of several professional associations for many years, including her service as Chair of a Food and Drug Law Institute Committee. She has also served on the President’s Council at Immaculata University and is a member of the Central Atlantic Association of Food and Drug Law Officials. Ms. Termini was admitted in 2018 to the bar of the United States Supreme Court.