Professionalism, Politics, Foreign Corrupt Practices, Product Classification, Globalization and the Future 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, cosmetics and dietary supplements? The answer is multifaceted and complex. Yet, the major focus should be that of public protection to uphold the tenets of the Federal Food, Drug and Cosmetic Act. What should...
Professionalism, Politics, Foreign Corrupt Practices, Product Classification, Globalization and the Future
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, cosmetics and dietary supplements? The answer is multifaceted and complex. Yet, the major focus should be that of public protection to uphold the tenets of the Federal Food, Drug and Cosmetic Act. What should FDA focus on in terms of future focus? Cross cutting topics and special issues are de-tailed in this chapter. Counterterrorism remains in the forefront. Globalization plays a key role in the regulation of food, drugs, cosmetics, medical devices and biologics and this chapter high-lights FDA’s role outside of the United States to protect the United States public health from un-safe imported products. Product classification remains complicated. Legal decisions have illus-trated that intended use controls in determining product category. That is, the historical decisions of Line Away and Sudden Beauty still provide judicial guidance on whether the product is a food, drug, cosmetic, medical device, dietary supplement or combination product. The question remains whether product categorization should be revisited to amend the FDCA.
The role of professionalism, ethics, accountability and “corporate governance” remain criti-cal for public trust. FDA has post employment restrictions and there is a statutory application to former employees including a cooling off period. Jurisdiction or the authority of FDA to regulate remains imperative.
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.