Professionalism, Politics, Foreign Corrupt Practices, Product Classification, Globalization and the Future: Food and Drug Law Book 12 of 12

Professionalism, Politics, Foreign Corrupt Practices, Product Classification, Globalization and the Future: Food and Drug Law Book 12 of 12

by Roseann B. Termini, Esq.
Professionalism, Politics, Foreign Corrupt Practices, Product Classification, Globalization and the Future: Food and Drug Law Book 12 of 12

Professionalism, Politics, Foreign Corrupt Practices, Product Classification, Globalization and the Future: Food and Drug Law Book 12 of 12

by Roseann B. Termini, Esq.

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Overview

Professionalism, civility, accountability and "corporate governance" remain critical for public trust. Cross cutting topics and special issues are detailed in this Book. Over the years, controversy has existed regarding FDA decision-making and referred to as "politically charged" such as COVID-19 issues regarding the rush for reliable testing, vaccines and treatment. Morality based determinations also have political implications as illustrated by the Plan B decisions. The question that lingers is whether FDA is truly a science-based agency. Another issue is that of the revolving door impact on post-employment. FDA has post-employment restrictions and there is a statutory application to former employees including what is termed "a cooling off" period.
Product classification is a key topic throughout this Book. The intended use rule for tobacco discussed in Book XI, is an excellent example of the complications of product classification. Legal decisions have illustrated that intended use controls in determining product category. That is, the historical decisions of Line Away and Sudden Beauty still provide judicial guidance for regulatory purposes about whether the product is a food, drug, personal care cosmetic product, medical device, dietary supplement or combination product. The question remains whether product categorization should be revisited with a possible amendment of the Food, Drug and Cosmetic Act.
The Food, Drug and Cosmetic Act expressly details that FDA cannot regulate the practice of medicine. This exact issue arose in the case of Regenerative Medicine, LLC. The Court of Appeals settled that the product in question in Regenerative Medicine was a drug/biologic. The court rejected the practice of medicine argument set forth by Regenerative Medicine.
Counterterrorism remains in the forefront and globalization plays a key role in the regulation of food, drugs, cosmetics, medical devices and biologics. This chapter highlights FDA's role outside of the United States to protect the United States public health from unsafe imported products. Jurisdiction or the authority of FDA to regulate remains imperative. Further the impact of the Foreign Corrupt Practices Act is detailed.
What does the future hold in terms of food and drug regulation? How should FDA regulate tobacco products, food, human and veterinary drugs, biologics, medical devices, personal care cosmetic products and dietary supplements? Think about how the regulation of tobacco products fits in the scheme of traditional FDA regulation. Consider how societal mores and culture impact on regulation. The answer is multifaceted and complex. The major focus necessitates a public protection stance to uphold the tenets of the Federal Food, Drug and Cosmetic Act. Finally, this Book concludes with professional practice recommendations.


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Product Details

BN ID: 2940160997902
Publisher: FORTI Publications
Publication date: 01/09/2022
Series: Food and Drug Law , #12
Sold by: Barnes & Noble
Format: eBook
File size: 177 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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