Human Drug Regulation -- Approvals, Promotion, Marketing, Warnings, Accountability, and Postmarket Surveillance: Food and Drug Law Book 5 of 12

Human Drug Regulation -- Approvals, Promotion, Marketing, Warnings, Accountability, and Postmarket Surveillance: Food and Drug Law Book 5 of 12

by Roseann B. Termini, Esq.
Human Drug Regulation -- Approvals, Promotion, Marketing, Warnings, Accountability, and Postmarket Surveillance: Food and Drug Law Book 5 of 12

Human Drug Regulation -- Approvals, Promotion, Marketing, Warnings, Accountability, and Postmarket Surveillance: Food and Drug Law Book 5 of 12

by Roseann B. Termini, Esq.



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Book V imparts an across-the-board analysis of drug law topics and significant legislation including information about the drug development process, from test-tube to new drug application review as well as the investigational drug review process and experimental treatments. FDA approved the first drug using 3-D technology in 2015. In 2018, FDA approved three drugs to prevent migraines. Furthermore, in 2018, the first botanically extracted cannabis product, Epidiolex was approved. In 2021, the Ensuring Innovation Act was signed into law providing clarification concerning exclusively as a "new chemical entity". The Act exchanges the term "active ingredient" with the term "active moiety. FDA approval mechanisms for new and generic drugs as well as biosimilars, investigational drugs, direct-to-consumer advertising, "off-label" enforcement, corporate accountability, drug reimportation, and post market surveillance are covered. 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, user fees, over-the-counter product labeling, direct-to-consumer promotion and includes a discussion of off-label promotion. 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. Thompson v. Western States Medical Center invalidated Section 127 of FDAMA concerning promotion of pharmacy compounding. The decisions of Perez, Schering Plough, Centocor and Johnson distinguish the impact of direct-to-consumer promotion on the learned intermediary doctrine
This Book contains landmark United States Supreme Court legal decisions. 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. Duty to warn issues that involve the manufacturer, physician and pharmacist are included.
Today preemption in failure to warn cases presents a complex dilemma between federal and state tort actions. 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 Court in Mutual Pharmaceutical set forth a demarcation between generic and brand name drugs and the right to recovery in state court. Rulemaking proceedings to overcome the brand and generic discrepancy were initiated in 2013 and was eventually withdrawn in 2019. The United States Supreme Court in the 2011 Sorrell decision determined that a State regulation precluding the sale of data violated the First Amendment. Similarly, First Amendment principles prevailed in the off-label cases of Amarin and Caronia, both Federal 2nd Circuit decisions and fact specific. Yet off-label issues remain controversial. The Supreme Court set forth in the landmark Actavis decision that the Federal Trade Commission can review settlements between brand and generic companies commonly referred to as pay-for-delay.
What does the future hold for drug discovery? Succinctly stated there is promise for further innovation in development, approvals and additional stringent post marketing surveillance.

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Product Details

BN ID: 2940160968247
Publisher: Forti Publications
Publication date: 01/07/2022
Series: Food and Drug Law , #5
Sold by: Barnes & Noble
Format: eBook
File size: 862 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, contained in the new print eighth 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.

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