All Matters FDA March 31 Virtual Symposium

Food and Drug Law books  published 2022 new editions —Full Print and 12 Subject specific E-Books and a full print E-Book.  Please pass on to colleagues and anyone  you think would benefit.
https://fortipublications.com print and subject specific E-book links

12th Annual Food and Drug Law Symposium

Find out the latest about COVID-19 from FDA’s Biologics Center Director Dr. Marks and other notable speakers. Other topics include criminal and civil enforcement, mandatory food recalls, vaping, e-cigarettes, unsafe pet products in the marketplace. 

Moderator:

  Christopher Mondics  —  Legal Affairs Journalist, Philadelphia, PA

Invited Speakers:

  Hon. Giovanni O. Campbell  —   Philadelphia Court of Common Pleas     Ethics and Professional Conduct

  Brook Duer, Esquire  —   Center for Agricultural & Shale Law, Penn State Univ.     Food Law Cases

  Michael Helbing, Esquire  —   Associate Chief Counsel for Enforcement, U.S. Food & Drug Administration     Enforcement

  George D. Lapsley  —   Food Safety Expert    Court Appointed Expert – Miller’s Organic Farm 

  Peter Marks, M.D., PhD.,  —   Director, Center for Biologics Evaluation & Research U.S. Food & Drug Administration    
COVID-19 Vaccines

  Matthew Noonan and Lillian Hsu  —   U.S. Food & Drug Administration FDA Preventive Controls (PC) experts in CFSAN Office of Compliance     Enforcement

  Jessica J. Sleater, Esquire  —   Andersen Sleater Sianni LLC, New York,  NY      Pet Product Safety

  Roseann B. Termini, Esquire  —   Food & Drug Law Legal Scholar, Food & Drug Law Courses, Delaware Law School    
Symposium Director     Year in Review

  Julia Tierney, Esquire  —   Chief of Staff, U.S. Food & Drug Administration     FDA Through the Pandemic: COVID-19 and Beyond 

4 CLE credits (2 Ethics & 2 Substantive) in DE and PA

REGISTRATION NOW OPEN! All Matters FDA March 31 Virtual

Save the Date March 31, 2022

1pm-5pm Virtual

Registration NOW OPEN >

12th Annual Food and Drug Law Symposium

Find out the latest about COVID-19 from FDA’s Biologics Center Director Dr. Marks and other notable speakers. Other topics include criminal and civil enforcement, mandatory food recalls, vaping, e-cigarettes, unsafe pet products in the marketplace.  Invited Speakers/Designees to date include:

Moderator:

  Christopher Mondics  —  Legal Affairs Journalist, Philadelphia, PA

Invited Speakers:

  Hon. Giovanni O. Campbell  —   Philadelphia Court of Common Pleas     Ethics and Professional Conduct

  Brook Duer, Esquire  —   Center for Agricultural & Shale Law, Penn State Univ.     Food Law Cases

  Michael Helbing, Esquire  —   Associate Chief Counsel for Enforcement, U.S. Food & Drug Administration     Enforcement

  George D. Lapsley  —   Food Safety Expert    Court Appointed Expert – Miller’s Organic Farm 

  Peter Marks, M.D., PhD.,  —   Director, Center for Biologics Evaluation & Research U.S. Food & Drug Administration    
COVID-19 Vaccines

  Matthew Noonan and Lillian Hsu  —   U.S. Food & Drug Administration FDA Preventive Controls (PC) experts in CFSAN Office of Compliance     Enforcement

  Jessica J. Sleater, Esquire  —   Andersen Sleater Sianni LLC, New York,  NY      Pet Product Safety

  Roseann B. Termini, Esquire  —   Food & Drug Law Legal Scholar, Food & Drug Law Courses, Delaware Law School    
Symposium Director     Year in Review

  Julia Tierney, Esquire  —   Chief of Staff, U.S. Food & Drug Administration     FDA Through the Pandemic: COVID-19 and Beyond 

4 CLE credits (2 Ethics & 2 Substantive) in DE and PA

UPDATE! All Matters FDA March 31 Virtual

UPDATE!

Save the Date March 31, 2022

1pm-5pm Virtual

Pre Registration: https://bit.ly/all-matters-fda-2022

12th Annual Food and Drug Law Symposium

Find out the latest about COVID-19 from FDA’s Biologics Center Director Dr. Marks and other notable speakers. Other topics include criminal and civil enforcement, mandatory food recalls, vaping, e-cigarettes, unsafe pet products in the marketplace.  Invited Speakers/Designees to date include:

Moderator:

  Christopher Mondics  —  Legal Affairs Journalist, Philadelphia, PA

Invited Speakers:

  Hon. Giovanni O. Campbell  —   Philadelphia Court of Common Pleas     Ethics and Professional Conduct

  Brook Duer, Esquire  —   Center for Agricultural & Shale Law, Penn State Univ.     Food Law Cases

  Michael Helbing, Esquire  —   Associate Chief Counsel for Enforcement, U.S. Food & Drug Administration     Enforcement

  George D. Lapsley  —   Food Safety Expert    Court Appointed Expert – Miller’s Organic Farm 

  Peter Marks, M.D., PhD.,  —   Director, Center for Biologics Evaluation & Research U.S. Food & Drug Administration    
COVID-19 Vaccines    and    Alzheimer’s Aduhelm® Approval

  Matthew Noonan and Lillian Hsu  —   U.S. Food & Drug Administration FDA Preventive Controls (PC) experts in CFSAN Office of Compliance     Enforcement

  Jessica J. Sleater, Esquire  —   Andersen Sleater Sianni LLC, New York,  NY      Pet Product Safety

  Roseann B. Termini, Esquire  —   Food & Drug Law Legal Scholar, Food & Drug Law Courses, Delaware Law School    
Symposium Director     Year in Review

  Julia Tierney, Esquire  —   Chief of Staff, U.S. Food & Drug Administration     FDA Through the Pandemic: COVID-19 and Beyond 

4 CLE credits (2 Ethics & 2 Substantive) in DE and PA

All Matters FDA March 31 Virtual

Save the Date March 31, 2022

1pm-5pm Virtual

Find out the latest about COVID-19 from FDA’s Biologics Center Director Dr. Marks and other notable speakers. Other topics include criminal and civil enforcement, mandatory food recalls, vaping, e-cigarettes, unsafe pet products in the marketplace.  Invited Speakers/Designees to date include:

Brook Duer, JD, Pennsylvania State Univ., Center for Agriculture Law

Michael Helbing, JD, Office of Chief Counsel, U.S. Food and Drug Administration

Peter Marks, MD, PhD, Director, Center for Biologics, U.S. Food and Drug Administration

Christopher Mondics, Moderator

Matthew Noonan and Lillian Hsu, FDA Preventive Controls (PC) experts in CFSAN Office of Compliance, U.S. Food and Drug Administration  

Jessica Sleater, Esq. Veterinary Medicine, Pet Products

Roseann B. Termini, Esq., Food and Drug Law Cutting Edge Issues including Vaping

Julia C.Tierney, JD, Chief of Staff, U.S. Food and Drug Administration


Further Info. Roseann Termini: rbtermini@widener.edu

50 Years Post-Controlled Substances Act: The War on Drugs Rages on with Opioids at the Forefront[1]

https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3432531

Ohio Northern University Law Review 46 Ohio N. U. L. Rev.1 (2020) Lead Article.

Roseann B. Termini** and Rachel-Malloy Good*

ABSTRACT

Introduction: Crisis Overview

It is not a hyperbole or a mistaken use of words to state that the United States is in the midst of an Opioid Crisis.[2]  Nearly 200 people die each day from a drug overdose, with nearly 70% of those dying from an opioid-related overdose.[3]  Roughly two million Americans have a “substance use disorder [(SUD)] related to prescription opioid pain medication.”[4]  An estimated eight million children live with at least one parent with a substance use disorder.[5]  Over 35% of children who entered the foster care system in 2016 were removed from their parents due to parental substance abuse.[6]  Between 1999 and 2016, nearly 9,000 children died as a result of opioid poisoning; approximately 81% of those were classified as “unintentional deaths,” 5% were the result of suicide, and 2% were due to homicide.[7]  When broken down further by age group, nearly one quarter of all children under the age of five who died of opioid poisoning died as a result of homicide.[8]  Undoubtedly, there is a crisis and undoubtedly, there is no quick fix.

When a person dies from an overdose, practitioners do not use universal classifications or definitions to determine and record the cause of death[9]; however, according to the Centers for Disease Control and Prevention (CDC), nearly 40% of all opioid overdose deaths in the United States in 2017 involved a prescription opioid, and roughly one third were due to heroin overdose.[10]  Over 47,000 of the roughly 70,000 overdose deaths in 2017 were related to opioids.[11]  As a point of reference, opioid related deaths exceeded the number of individuals killed in car accidents for the first time in 2017.[12]  Opioids have been touted as a gateway drug and, by way of illustration, among those who initially started using heroin between 2000 and 2013, nearly 75% reported having misused prescription opioids prior to starting heroin; this is compared to the 1960s when 80% of heroin users in treatment reported starting heroin prior to using any prescription opioids.[13]  As a result of the staggering statistics linking prescription opioids directly to overdose deaths and heroin addiction, this article focuses on how prescription opioids created the quagmire our nation is mired in today.


c. 2019 Roseann B. Termini and Rachel Malloy-Good. All rights reserved.

[1]. Comprehensive Drug Abuse Prevention and Control Act of 1970, Pub. L. 91–513, tit. II, §101, 84 Stat. 1242 (1970), codified at 21 U.S.C. sec. 801 et seq.

Authors Note: The authors dedicate this article to all of those who have, and are, suffering due to opioids—to the families who have lost their loved ones; and to the people battling addiction; to the people struggling with chronic pain. This article is also dedicated to all of the individuals who are working each and every day to bring closure to this crisis.  The authors thank Ms. JanetLindenmuth, M.S., research law librarian at Delaware Law School who provided valuable research for this article.  The authors also thank Jeffrey Williams Editor-in-Chief of the Ohio Northern University Law Review and the Editorial Board.

* Rachel Malloy-Good, B.A magna cum laude, M.A academic distinction, Delaware Law School Dean’s list (J.D. expected May 2020). Ms. Malloy-Good has spent her career in an urban school district supporting students with special needs.  It was in seeing opioids impact her students, addiction that has impacted her friends, and watching family members suffer from chronic pain that she became interested in researching this topic. Ms. Malloy-Good would like to thank her daughter, family, friends and gifted Professor Roseann B. Termini for support in working on this article. Author contact: r.malloygood@gmail.com

** Roseann B. Termini, B.S. magna cum laude, M.Ed. Fellow, J.D., a food and drug law attorney, is the author of Food and Drug Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods, Dietary Supplements, Personal Care, Veterinary and Tobacco Products www.fortipublications.com (2019). She teaches several Food and Drug Law courses at Delaware Law School, Widener University School of Law. Ms. Termini dedicates this article to the memory of her parents who instilled values that fostered the determination to write this article, her children and non-lawyer friends for reading many drafts to comport with plain language considering this complicated issue. Finally, Ms. Termini thanks her co-author Ms. Rachel Malloy-Good for her dedication to this topic. Author contact: rbtermini@widener.edu

            [2].   Opioid Crisis Fast Facts, CNN Health (Oct. 5, 2019, 9:14 AM), https://www.cnn.com/ 2017/09/18/health/opioid-crisis-fast-facts/index.html.

            [3].   Drug Overdose Deaths, Centers for Disease Control and Prevention (June 27, 2019), https://www.cdc.gov/drugoverdose/data/statedeaths.html.

            [4].   Nearly One in Three People Know Someone Addicted to Opioids, American Psychiatric Association (May 7, 2018), https://www.psychiatry.org/newsroom/news-releases/nearly-one-in-three-people-know-someone-addicted-to-opioids-more-than-half-of-millennials-believe-it-is-easy-to-get-illegal-opioids.

            [5].   April Dirks, The Opioid Epidemic: Impact on Children and Families, 2 J. Psychiatry and Psychiatric Disorders 9, 10 (2018).

            [6].   Child Welfare and Treatment Statistics, National Center on Substance Abuse and Child Welfare (last visited Oct. 14, 2019), https://ncsacw.samhsa.gov/resources/child-welfare-and-treatment-statistics.aspx.

            [7].   Julie R. Gaither et al.U.S. National Trends in Pediatric Deaths from Prescription and Illicit Opioids, JAMA Network, Pediatrics (Dec. 28, 2018), https://jamanetwork.com/journals/jamanetwork open/fullarticle/2719580.

            [8].   Id.

            [9].   Bruce Goldberger et al.Uniform Standards and Case Definitions for Classifying Opioid-Related Deaths: Recommendations by a Samhsa Consensus Panel, 32 J. Addict Disease 231, 232 (2013).

          [10].   Lawrence Scholl et al.Drug and Opioid-Involved Overdose Deaths – United States, 2013–2017, 67 Morbidity and Mortality Weekly Report 1419, 1420, 1422 (2019).

          [11].   Id. at 1420.

          [12].   National Safety Council, Preventable Deaths – Odds of Dying, National Safety Council Injury Facts (last visited Oct. 14, 2019), https://injuryfacts.nsc.org/all-injuries/preventable-death-overview/odds-of-dying/.

          [13].   National Institute on Drug Abuse, Prescription Opioids and Heroin 6 (2018) [hereinafter Prescription opioids and Heroin].