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.
Biotechnology and Biologic Products Regulationby Roseann B. Termini, Esq.
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This volume focuses on major issues concerning biologics. Did you know that according to a recent Congressional Research Report, the projected percentage increase of biotechnology products including bioengineered vaccines and biologics is predicted to increase to nearly 50% by 2018. To that end, this volume includes a strategic goal plan for the Center for Biologics Evaluation and Research (CBER). The authority of CBER stems from the Public Health Services Act (PHSA) and specific sections of the United States Food Drug and Cosmetic Act (FDCA). Both the PHSA and FDCA impact on these regulated products. 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 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 may be 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. Biosimilars have become a multi-billion dollar market. Congress passed the Biologics Price Competition and Innovation Act (BPCI or Biosimilars) Act, included as Title VII of the Patient Protection and Affordable Care Act of 2010 Pub.L. 111-148 as amended by the Health Care and Reconciliation Act of 2010 (Healthcare Reform Act). The Biosimilars Act established a 12-year exclusivity period before biosimilars can be approved for marketing in the United States.
Special topics besides biosimilars include bioterrorism, the “Practice of Medicine” and botulinum Toxin Type A “Botox”. Examples of voluntary recalls, gene therapy initiatives and warning letters are included. Each chapter contains critical analysis issues to explore. Finally, a far reaching United States Supreme Court decision occurred in 2013. In Association for Molecular Pathology v. Myriad Genetics the issue hinged on whether naturally occurring human genes and/or isolating those genes from the body were a patentable invention. The United States Supreme Court pronouncement in Myriad is included.
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