This volume focuses on significant issues and legal cases in Human Drug Law. Volume V contains United States Supreme Court legal decisions that have impacted on the practice of pharmaceutical regulatory law. The United States Food and Drug Administration’s (FDA) mission, in accordance with the Federal Food, Drug and Cosmetic Act (FDCA), is to protect the public health and safety. This volume imparts a comprehensive analysis of drug law topics such as significant legislation, the Food and Drug Administration ...
This volume focuses on significant issues and legal cases in Human Drug Law. Volume V contains United States Supreme Court legal decisions that have impacted on the practice of pharmaceutical regulatory law. The United States Food and Drug Administration’s (FDA) mission, in accordance with the Federal Food, Drug and Cosmetic Act (FDCA), is to protect the public health and safety. This volume imparts a comprehensive analysis of drug law topics such as significant legislation, the Food and Drug Administration approval mechanisms for both new and generic drugs as well as biosimilars investigational drugs, direct to consumer advertising, “off label” enforcement, corporate accountability, drug reimportation, pharmacy compounding, counterfeit products and post market surveillance.
Information about the drug development process, from test-tube to new drug application review, the investigational drug review process and experimental treatments is provided. Details about generic drug products are covered and recent United States Supreme Court cases such as Mutual Pharmaceutical are included. The impact of copyright infringement is discussed in the decision of Smithkline Beecham Consumer Health Care, L.P. v. Watson Pharmaceuticals. Other important topics include bioequivalence, the MedWatch program and user fees and over-the-counter product labeling. This volume contains information on advertising, includes a dis-cussion of off label promotion, and legal decisions. For example, in Washington Legal Foundation v. Henney, the court invalidated the restrictions imposed by FDA on off-label uses because of First Amendment violations. The decisions of Perez, Schering Plough and Johnson distinguish the impact of direct-to-consumer promotion on the learned intermediary doctrine. The decision of Thompson v. Western States Medical Center invalidated Section 127 of FDAMA concerning promotion of pharmacy compounding. This volume contains cases about duty to warn issues including that of the manufacturer, physician and pharmacist.
Landmark cases involving the legal concept of preemption are included as well. Preemption is a legal term of art that emanates from the Supremacy Clause (Article VI, clause 2) of the United States Constitution. Article VI, clause 2 prohibits states from enacting laws that conflict with federal law unless the federal law contains explicit preemption language. The 2009 landmark United States Supreme Court decision, Wyeth v. Levine, concerned a brand name drug and the ability to bring a lawsuit in state court. Conversely, another United States Supreme Court case decided in 2011, Pliva v. Mensing involved a generic drug and held preemption prevailed. The United States Supreme Court in the 2011 Sorrell decision determined that a State regulation precluding the sale of data violated the First Amendment. Finally, the landmark Actavis Supreme Court decision concerning pay-for-delay is included. Each chapter contains critical analysis issues to explore.
Roseann B. Termini, B.S., Ed. M., J.D. has over twenty-five years of extensive experience in food and drug law. This volume, 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.