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].

The Latest ‘Federal Movement’ in the Food and Drug Law Arena: The Federal Right-to-Try or Rather Right-to-Know and Thus Request Investigational Therapies for Individuals with a Life-Threatening Disease or Condition

Indiana Health Law Review, Vol. 16, Issue 1, November 2018

Abstract and link:https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3239582

Does the recently enacted Federal Right-to-Try Act provide improved access for the desperately ill? Will insurance companies provide reimbursement for a patient to undergo such investigational therapies? Is the manufacturer protected in terms of lawsuits? That is, does the patient relinquish the right to bring a legal action? Will physicians comprehend the pathway and advocate for their patients? Does this new law guarantee “any novel federal right”? The national state movement regarding Right-to-Try state legislation spurred the enactment of the Federal Right-to-Try (Federal Right-to-Try Act) legislation passed in 2018. Yet, even prior to the enactment of the Federal Right-to-Try law, the United States Federal Food and Drug Administration (FDA) has had mechanisms in place for those terminally ill who do not qualify for a clinical trial.

This article provides a Federal Primer on the Investigational Drug, Biologic and Device Process, details a similar national right-to-know movement in the food and drug law arena that led to federal legislation perhaps comparable to how the Federal Right-to-Try Act was enacted and includes a discussion about the state right to try movement which conceivably led to the enactment of the Federal Right-to-Try Act. There are more queries than unambiguous answers regarding the recently enacted Federal Right-to-Try Act. The federal law in essence could prove troublesome and confusing with both the state Right-to-Try measures due to, for instance, issues of national uniformity and preemption. Further, could the recently enacted Federal Right-to-Try Act ultimately be detrimental to the patient in terms of lack of adequate safeguards and perhaps a false unrealistic sense of hope?

Opioids, Whistleblower Actions, Medical Device Safety, Food Defense, Personal Care Products Regulation, Dietary Supplement Regulation,Top Notables, and Other Matters FDA

FDA CONFERENCE “ALL MATTERS FDA”
Opioids, Whistleblower Actions, Medical Device Safety, Food Defense, Personal Care Products Regulation, Dietary Supplement Regulation,Top Notables, and Other Matters FDA

April 4, 2018 12:30–5:00 p.m.

“All Matters FDA” promises to be informative, focusing on the Food and Drug Administration’s top accomplishments across the food and drug law spectrum. Find out about “hot topics” and hear the latest from seasoned professionals.

Hear the Latest from these Experienced Invited Speakers:

Robert J. Durkin, Esq., M.S., R.Ph.—Deputy Director Office of Dietary Supplement Programs, Center for Food Safety and Applied Nutrition, Food and Drug Administration (FDA)

Charlene Fullmer, Esq.—Deputy Chief for Affirmative Litigation, Civil Division, United States Attorney’s Office, Eastern District of Pennsylvania

Kevin Spradlin—Intelligence Analyst, FBI, Washington D.C.

Matthew R. Noonan, Esq.—Compliance Officer, FDA Human & Animal Food Division

Stanley R. Milstein, Ph.D.—Former Acting Deputy Director (retired),, FDA Office of Cosmetics and Colors

 Hooman Noorchashm, M.D.—Cardiac Surgeon, Phila., Pennsylvania

Roseann B. Termini, Esq.—Food and Drug Law Legal Scholar; National Speaker, Online FDA Law Courses, Widener University, Delaware Law Schoo

Registration fee: $75;
Students with valid school ID: Free

Registration form available at delawarelaw.widener.edu/fdacle

For questions or for accessibility or special needs requests,
contact Carol Perrupato at DelawareLawCLE@widener.edu or 302-477-2178.
Food and Drug Law Association of Widener University Delaware Law School Wednesday,
Check-in begins at 12:00 p.m.
Widener University Delaware Law School
Ruby R. Vale Moot Courtroom
4 CLE Credits available in DE and PA (including one ethics credit)
NJ attorneys can self-report with our Certificate of Attendance
Course materials will be distributed electronically.

Registration Form

Name _________________________________________________________________________ Firm, Company or Organization ____________________________________________________ Attorney ID # (if applicable): Delaware _______________ Pennsylvania ______________ Address _______________________________________________________________________ City __________________________ State _____ Zip _________ Phone ___________________ Email address for confirmation purposes: ____________________________________________ Registration Fee: $75.00 _____

Students with valid school ID: Free _____

Payment Methods
CHECK: Please make checks payable to Widener University. I have enclosed a check in the amount of $ ____________.

CREDIT CARD: VISA and Master Card are accepted and processed by the University. Amount $___________. ________________
Card Number _______________________________Exp. Date_______ Security Code _____

Name on Card __________________________________ Signature_______________________________________

Please fax or mail this registration form to: Carol Perrupato, Widener University Delaware Law School, 4601 Concord Pike, Wilmington, DE 19803-0406 – fax number 302-477-2282. Questions or inquiries, please contact Carol Perrupato at 302-477-2178 or via email at caperrupato@widener.edu.

Opioids, Whistleblower Actions, Medical Device Safety, Food Defense, Personal Care Products Regulation, Dietary Supplement Regulation,Top Notables, and Other Matters FDA

FDA CONFERENCE “ALL MATTERS FDA”
Opioids, Whistleblower Actions, Medical Device Safety, Food Defense, Personal Care Products Regulation, Dietary Supplement Regulation,Top Notables, and Other Matters FDA

April 4, 2018 12:30–5:00 p.m.

All Matters FDA” promises to be informative, focusing on the Food and Drug Administration’s top accomplishments across the food and drug law spectrum. Find out about “hot topics” and hear the latest from seasoned professionals.

Hear the Latest from these Experienced Invited Speakers:

Robert J. Durkin, Esq., M.S., R.Ph.—Deputy Director Office of Dietary Supplement Programs, Center for Food Safety and Applied Nutrition, Food and Drug Administration (FDA)

Charlene Fullmer, Esq.—Deputy Chief for Affirmative Litigation, Civil Division, United States Attorney’s Office, Eastern District of Pennsylvania

Kevin Spradlin—Intelligence Analyst, FBI, Washington D.C.

Matthew R. Noonan, Esq.—Compliance Officer, FDA Human & Animal Food Division

Stanley R. Milstein, Ph.D.—Former Acting Deputy Director (retired),, FDA Office of Cosmetics and Colors

 Hooman Noorchashm, M.D.—Cardiac Surgeon, Phila., Pennsylvania

 Roseann B. Termini, Esq.—Food and Drug Law Legal Scholar; National Speaker, Online FDA Law Courses, Widener University, Delaware Law Schoo

Registration fee: $75;
Students with valid school ID: Free

Registration form available at delawarelaw.widener.edu/fdacle

For questions or for accessibility or special needs requests,
contact Carol Perrupato at DelawareLawCLE@widener.edu or 302-477-2178.
Food and Drug Law Association of Widener University Delaware Law School Wednesday,
Check-in begins at 12:00 p.m.
Widener University Delaware Law School
Ruby R. Vale Moot Courtroom
4 CLE Credits available in DE and PA (including one ethics credit)
NJ attorneys can self-report with our Certificate of Attendance
Course materials will be distributed electronically.

Registration Form

Name _________________________________________________________________________ Firm, Company or Organization ____________________________________________________ Attorney ID # (if applicable): Delaware _______________ Pennsylvania ______________ Address _______________________________________________________________________ City __________________________ State _____ Zip _________ Phone ___________________ Email address for confirmation purposes: ____________________________________________ Registration Fee: $75.00 _____

Students with valid school ID: Free _____

Payment Methods
CHECK: Please make checks payable to Widener University. I have enclosed a check in the amount of $ ____________.

CREDIT CARD: VISA and Master Card are accepted and processed by the University. Amount $___________. ________________
Card Number _______________________________Exp. Date_______ Security Code _____

Name on Card __________________________________ Signature_______________________________________

Please fax or mail this registration form to: Carol Perrupato, Widener University Delaware Law School, 4601 Concord Pike, Wilmington, DE 19803-0406 – fax number 302-477-2282. Questions or inquiries, please contact Carol Perrupato at 302-477-2178 or via email at caperrupato@widener.edu.

HOMEOPATHIC REMEDIES And FDA GUIDANCE —Long Overdue

 

Although FDA regulates homeopathic remedies, enforcement has lagged especially in comparison with the popularity and increased use of homeopathic remedies . Finally in late 2017, FDA issued a draft guidance entitled Drug Products Labeled as Homeopathic.” 

The draft guidance explains how FDA expects to prioritize enforcement and regulatory action with respect to drug and biological products, labeled as homeopathic and marketed in the United States without the required FDA approval. Once the final guidance is issued, FDA will withdraw Compliance Policy Guide (CPG) 400.400, “Conditions Under Which Homeopathic Drugs May be Marketed”, issued back on May 31, 1988.

What is homeopathy? The guidance defines homeopathy as follows: “Homeopathy is an alternative medical practice that has an historical basis in theory and practice first systematized in the late 1700s. Homeopathy is generally based on two main principles: (1) A substance that causes symptoms in a healthy person can be used in diluted form to treat symptoms and illnesses (known as “like-cures-like”) and (2) the more diluted the substance, the more potent it is (known as the “law of infinitesimals”).”

The definition of “drug” in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. 321(g)(1)) includes articles recognized in the Homeopathic Pharmacopoeia of the United States (HPUS) or any supplement to it. Homeopathic drugs are subject to the same regulatory requirements as other drugs. Senator Royal Copeland, was a physician and homeopathic proponent and finally a major sponsor of the 1938 FDCA.

What does the guidance state about enforcement? According to FDA, the agency recognizes resource limitations and intends to apply a risk-based enforcement approach to drug products labeled as homeopathic and marketed in the United States without the required FDA approval. Further, FDA expects to apply a risk-based enforcement approach to the manufacturing, distribution, and marketing of drug products labeled as homeopathic.  Categories include:

Products with reported safety concerns;

Products that contain or purport to contain ingredients associated with potentially significant safety concerns;

Products for routes of administration other than oral and topical—For example, unapproved injectable drug products and unapproved ophthalmic drug products pose a greater risk of harm to users due to their routes of administration;

Products intended to be used for the prevention or treatment of serious and/or life- threatening diseases and conditions;

Products for vulnerable populations; and

Products deemed adulterated under the Food, Drug and Cosmetic Act.

https://nccih.nih.gov/health/homeopathy

https://www.federalregister.gov/documents/2017/12/20/2017-27157/drug-products-labeled-as-homeopathic-draft-guidance-for-food-and-drug-administration-staff-and Federal Register Vol. 82, No. 243 (December 20, 2017) Notices 60403

http://bit.ly/2BLq1tF

 

 

 

 

Prison Sentences- Peanut Corp.of America Salmonella Tainted Peanut Products

Update-Sentences Affirmed on January 23, 2018 Corp. Executive Liability Sentence Largest Ever in Food Safety History 

AFFIRMED:  See: United States v. Parnell, et. al, No. 15-14400 (11th Cir. Jan. 23, 2018)  Click on the link for the appellate court decision. Court of Appeals Opinion

Former Peanut Corporation of America (PCA) President and Owner Stewart Parnell received a criminal prison sentence of 28 years in connection with the 2009 salmonella poisoning outbreak of 700 reported cases in 46 states. Expert evidence presented at trial detailed that there were nine deaths linked to PCAs tainted products. Parnell’s brother Michael received a 20 year prison sentence. The Quality Assurance employee received a 5 year sentence. They were sentenced based on their roles at PCA by shipping salmonella-positive peanut products and by falsifying microbiological test results.  A federal jury convicted the Parnell brothers in September 2014 on several counts of conspiracy, mail and wire fraud as well as selling misbranded food. Stewart Parnell was also convicted for introducing adulterated food into interstate commerce.  Stewart Parnell and Quality Assurance Manager Mary Wilkerson were also convicted of obstruction of justice. According to U. S. Justice Attorney Moore, “The sentence that was handed down today [Sept. 21, 2015] means that executives will no longer be able to hide behind the corporate veil”. The direct link to the sentences in the Parnell Salmonella Tainted Peanut Product case is below and court of appeals opinion above.

AFFIRMED:  See: United States v. Parnell, et. al, No. 15-14400 (11th Cir. Jan. 23, 2018 (affirmed)). Click on the link Court of Appeals Opinion

http://www.justice.gov/opa/pr/former-peanut-company-president-receives-largest-criminal-sentence-food-safety-case-two

All Matters FDA Conference

SAVE The DATE: March 21, 2018 from 1pm-4pm 

The Annual FDA Matters Conference at the Delaware Law School, Wilmington DE 

Learn from seasoned professionals from FDA, FBI and the U. S. Office of the Attorney General

Focus: Opioids, Medical Devices, Food Safety, Dietary Supplements, Criminal Cases and Other Matters FDA—Year in Review, Top Notables, and Looking Forward

In Brief : This “All Matters FDA” promises to be informative and related to the Food and Drug Administration’s top accomplishments across the food and drug law spectrum.