FDA Approves New Treatment for Alzheimer’s Disease

In an interesting decision FDA decided on June 7 to approve a controversial new treatment for Alzheimer’s Disease, Aducanumab (trade name Aduhelm)

What is Aduhelm?

Aduhelm is an amyloid beta-directed antibody indicated for the treatment of Alzheimer’s disease.

Why FDA Decided to Approve Aduhelm to Treat Alzheimer’s Disease https://www.fda.gov/drugs/news-events-human-drugs/fdas-decision-approve-new-treatment-alzheimers-disease

Approval Path: Aduhelm was approved under the Accelerated Pathway. According to Dr. Patrizia Cavazzoni, Director, FDA Center for Drug Evaluation and ResearchCDER Director the “Accelerated Approval https://www.fda.gov/drugs/information-health-care-professionals-drugs/accelerated-approval-program pathway, under which the FDA approves a drug for a serious or life-threatening illness that may provide meaningful therapeutic benefit over existing treatments when the drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients and there remains some uncertainty about the drug’s clinical benefit.” Further, FDA consider Aduhelm a novel treatment. The last time a treatment for Alzheimer’s was approved was in 2003. Dr. Cavazzoni emphasized that “Aduhelm is the first treatment directed at the underlying pathophysiology of Alzheimer’s disease, the presence of amyloid beta plaques in the brain.”

Dr. Cavazzoni concluded that : “FDA will continue to monitor Aduhelm as it reaches the market and ultimately the patient’s bedside. Additionally, FDA is requiring Biogen to conduct a post-approval clinical trial to verify the drug’s clinical benefit. If the drug does not work as intended, we can take steps to remove it from the market. But hopefully, we will see further evidence of benefit in the clinical trial and as greater numbers of people receive Aduhelm.” https://www.fda.gov/drugs/news-events-human-drugs/fdas-decision-approve-new-treatment-alzheimers-disease

FDA Authorizes Emergency Use for Adolescents – Pfizer-BioNTech COVID-19 Vaccine

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use

On May 10, another milestone occurred in the quest to prevent coronavirus disease commonly known as COVID-19. FDA gave the go ahead for expanded emergency use authorization (EUA) to Pfizer-BioNTech for the adolescent age group from ages 12 though 15.

According to FDA, approximately 1.5million cases of COVID-19 have occurred in that age group from March 1, 2020 through April 30, 2021.

Acting FDA Commissioner Janet Woodcock, M.D. “Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”

Further, on May 10, FDA recently updated the Fact Sheets for Vaccine Providers, Recipients and Caregivers- direct links:

Healthcare Providers: https://www.fda.gov/media/144413/download

Recipients and Caregivers: https://www.fda.gov/media/144414/download

COVID-19 Impact on the Regulated Industry and Regulators

COVID-19-Impact on the Regulated Industry

COVID-19-Impact on the Regulated Industry
Date: November 18, 2020 
Time: Live 12:00pm (EST) / 9:00am (PST) / 17:00 (GMT) / 18:00 (CET)
Location: Webinar/Online

Join us for a unique opportunity to find out more about the COVID-19 pandemic in this nearly daily changing landscape. What you think applies today might change drastically tomorrow. This webinar will explore recent FDA activity regarding COVID-19 including an upcoming program discussion on inspections and other enforcement methods in the COVID-19 ERA. This is a Free CfPA Exclusive FREE Webinar.

Can’t make the LIVE webinar? Register now and we’ll send you a copy of the recording.

Registration Link: https://www.cfpa.com/CourseDescription/CourseDescription/2011907OL2974L/2974?utm_source=Listrak&utm_medium=Email&utm_term=Register+Now_2974&utm_campaign=2947_Free_1


Presented by: Roseann B. Termini, B.S., Ed. M., J.D. 
Ms. Termini has extensive experience in food, drug, medical devices, personal care, dietary supplement, tobacco and veterinary products regulation. Ms. Termini recently published a new comprehensive edition, both in print and E-book formats, of Food and Drug Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods, Dietary Supplements, Personal Care, Veterinary and Tobacco Products (2019). Ms. Termini is also a featured speaker at international and national conferences and webinars.

FDA COVID-19 Treatment Approval

First FDA Approval for COVID-19: Veklury (remdesivir), an antiviral drug, manufactured by Gilead. It is for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization. 

The FDA granted Gilead’s application Fast Track and Priority Review designations. Further FDA granted this application a  Material Threat Medical Countermeasure Priority Review Voucher. This means additional incentives because COVID-19 falls within this category; that is, medical products intended to treat or prevent harm from specific chemical, biological, radiological and nuclear threats. It is important to mention that this approval does not include the entire population that had been authorized to use Veklury under an Emergency Use Authorization (EUA) (issued on May 1, 2020). 

NOTE—FDA had granted Gilead Sciences Orphan Drug status for remdesivir and orphan designation for the “Treatment of coronavirus disease 2019 (COVID-19)” (March 23, 2020) which means tax advantages and exclusivity; however, in an unusual twist,  Gilead requested on March 25, 2020 that FDA rescind orphan drug designation.

https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19

https://www.gilead.com/news-and-press/press-room/press-releases/2020/10/us-food-and-drug-administration-approves-gileads-antiviral-veklury-remdesivir-for-treatment-of-covid19

COVID-19, CBD, VAPING, PET PRODUCTS SAFETY, OPIOID EPIDEMIC

This week, on Wednesday October 21, from 1-4pm, the FDLA, Delaware Law will be virtually hosting its “All Matters FDA” Symposium which will host a variety of speakers from professors, to judges, to other professionals in the field to discuss a range of topics such as: opioids and pharmaceuticals, COVID-19, vaping, cannabis law, and pet products. Just follow the link below to register. Even if you can only attend in part we hope you will be able to join us!   If you register and have a conflict the session will be recorded.

The Symposium will be hosted over zoom, and a link will be sent out beforehand.

Even if you can only attend in part we hope you will be able to join us!   If you register and have a conflict the session will be recorded.

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].

Top 5 Accomplishments— FDA Year in Review and Wish List!

Year in Review—Top 5 (well more than 5) Highlights of FDA Accomplishments and FTC in 2014.  Here are just a few top accomplishments in food and drug law in 2014. Last year, the question posed was whether the United States really needs an “FDA”. The role and mission of FDA has been debated for years.  The FDA role ranges from that of a regulator, watchdog and facilitator. Commentary ranges from overbearing federal regulation to lack of public protection. Yet, based on these selected accomplishments, FDA provides an important function in keeping with the mission of the Food, Drug and Cosmetic Act and the numerous amendments. Although the FDA has across the board accomplishments, the following are standouts and all involve safety—Ebola, Power Morcellators,  Food Safety Modernization Act Supplemental Proposed Rules, Tobacco Enforcement, Calorie Disclosure Rules, Criminal Liability, Sunscreen Innovation Act and Diet Products….just to name a few. 

CAFFEINE-INFUSED SHAPEWEAR

Norm Thompson Outfitters and Wacoal America Settle FTC Charges Over Weight-Loss Claims The Federal Trade Commission approved two final orders settling charges that two companies, Norm Thompson Outfitters. Inc., and Wacoal America, Inc., misled consumers regarding the ability of their caffeine-infused shapewear undergarments to reshape the wearer’s body and reduce cellulite. According to the FTC’s complaints, the two companies’ marketing claims for their caffeine-infused products were false and not substantiated by scientific evidence. The products, made with Lytess brand fabrics, were sold via mail order and on the company’s Norm Thompson Outfitters, Sahalie, Body Solutions, and Body Belle websites. FTC alleged that the company made claims that wearing its shapewear would eliminate or substantially reduce cellulite; reduce the wearer’s hip measurements by up to two inches and their thigh measurements by one inch; and reduce thigh and hip measurements “without any effort.” The complaint against Wacoal America contained similar allegations. It charged that the company’s iPants supposedly slimmed the body and reduced cellulite. Specifically, the company made false and unsubstantiated claims that wearing iPants would: substantially reduce cellulite; cause a substantial reduction in the wearer’s thigh measurements; and destroy fat cells, resulting in substantial slimming. http://www.ftc.gov/enforcement/cases-proceedings/132-3095/wacoal-america-inc-matter

EBOLA OUTBREAK 

Currently, the standard treatment for patients infected with the Ebola virus is supportive therapy. However, that could change in the near future. NIH reported in late 2014 that an experimental vaccine to prevent Ebola virus disease proved successful in phase I clinical trial in all 20 healthy adults who received it. The vaccine is being developed by the NIH’s National Institute of Allergy and Infectious Diseases and GlaxoSmithKline. Expedited review is in the works for the priority review track as well as immunity protection.The experimental drug ZMapp was used in 2014 to treat a few patients infected with Ebola; however, it is still uncertain to ascertain the effectiveness of ZMapp. According to the manufacturer, the product is in the experimental stages and clinical trials are needed. Besides Mapp Biopharmaceutical Inc., Tekmira, Chimerix and BioCryst Pharmaceuticals have therapeutic products in early developmental stages for clinical trials. See: Peter Loftus and Betsy McKay, Race is On for Ebola Drug, All St. J. A1 (Oct. 18-19 2014); Betsy McKay and Peter Loftus, Wall St. J. A7 Experimental Drugs Are Approved for Use in Fighting Ebola in West Africa (Aug. 13, 2014);http://www.cdc.gov/vhf/ebola/outbreaks/guinea/qa-experimental-treatments.html

http://www.nytimes.com/2014/08/07/business/an-obscure-biotech-firm-hurries-ebola-treatment.html

http://www.washingtonpost.com/blogs/monkey-cage/wp/2014/08/06/ebola-research-ethics-and-the-zmapp-serum/

POWER MORCELLATORS—Warning and Immediate Guidance

Laparoscopic Uterine Power Morcellation: Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power Morcellators; Guidance for Industry and Food and Drug Administration Staff  http://www.gpo.gov/fdsys/pkg/FR-2014-11-25/html/2014-27857.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm

CRIMINAL FELONY CONVICTIONS 

Corporate Executive Liability Food Safety—Felony Conviction Peanut Corporation of America Background and Corporate Significance The former owner of Peanut Corporation of America Peanut Corp.) Stewart Parnell was convicted on September 19, 2014 of conspiracy and other charges in connection with a deadly salmonella outbreak that occurred in 2008-2009. According to the Centers for Disease Control and Prevention, nine people died and over 700 others became ill in 2008-09 after eating peanut butter or other products prepared at the company’s plant in Georgia. Mr. Parnell, was found guilty on several counts, including wire fraud and obstruction of justice. The indictment was centered on a conspiracy to conceal that several of Peanut Corp.’s products were contaminated with salmonella. Others involved and convicted included the brother of Stewart Parnell, Michael Parnell, a food broker who worked on behalf of Peanut Corp. and the quality assurance manager, Mary Wilkerson, for obstruction of justice. Two other former Peanut Corp. employees has previously pled guilty to multiple charges. Prosecutors alleged that Peanut Corp. not only defrauded customers but also defrauded several national food companies by failing to inform them about the presence of food-borne pathogens in laboratory tests, including salmonella. According to prosecutors, in some instances, despite these results, Peanut Corp. officials totally falsified lab results, maintaining peanut products were safe for consumption. Further, at times, the Peanut Corp. failed to even perform testing. Although for years, corporate executives have been charged with misdemeanor offenses under the strict criminal liability theory known as the Park doctrine, this case is distinguishable. The Peanut Corp. case represents a felony prosecution under the Federal Food, Drug and Cosmetic Act. The Peanut Corp. prosecution serves as a wake up call to the regulated food safety industry.

CALORIE DISCLOSURE FINAL RULES

Vending Machines and Restaurant Menu Labeling Overview and link to final rules. http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm248732.htm

Introduction and Quick Summary FDA released the long awaited two final rules in early December (2014) regarding caloric disclosure The rules were proposed in April 2011 under section 4205 of the Affordable Care Act. The final rule is effective date is December 1, 2015 to afford vending machine operators and affected restaurants time to comply. The final rule summaries issued by FDA are below as well as a direct link and issue to consider.  Food Labeling; Calorie Labeling of Articles of Food in Vending Machines Requires operators who own or operate 20 or more vending machines to disclose calorie information for food sold from vending machines, subject to certain exemption.   

Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments Applies to restaurants and similar retail food establishments if they are part of a chain of 20 or more locations, doing business under the same name, offering for sale substantially the same menu items and offering for sale restaurant-type foods.

TOBACCO ENFORCMENT 

 Tobacco products are regulated so differently than other FDA regulated products due to the fact they are harmful yet still extensively used consumer products and are responsible for severe health problems in both users and non-users, including cancer, lung disease, and heart disease, which often lead to death. The focus remains on youth and the FDA is faced for 2015 with the Ecigarette issue and deeming. CTP established the Office of Compliance and Enforcement (OCE); however, enforcement is limited as FDA’s regulatory authority is dictated by the FSPTCP. CTP has filed actions for civil monetary penalties mainly for sales to minors. A Civil Money Penalty (CMP) Complaint is used to initiate an administrative legal action against a retailer that can result in the imposition of a fine, termed a Civil Money Penalty. As an example of enforcement efforts, FDA filed approximately 100 civil legal actions. FDA recently sent warning letters to retailers for selling to minors. Here is the direct link:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/Tobacco/ucm424581.htm

FOOD SAFETY

Food Safety Modernization Act Supplemental Proposed Rules: Did you know that much of the food that Americans consume originate from countries outside of the United States? The Food Safety Modernization Act (FSMA), signed into law back in January 2011, addresses imported food as well as food produced in the United States. Several proposed rules were issued in 2013 and now in 2014 supplemental proposed rules. Here is the direct link to the final and proposed rules.

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm253380.htm

SUNSCREEN INNOVATION ACT

Finally, the Sunscreen Innovation Act (SIA), recently signed into law in late 2014, (Public Law No: 113-195 Nov. 26, 2014) establishes a new process for the review and approval of over-the-counter sunscreen active ingredients. The SIA provides FDA with explicit, expedited deadlines for review. The SIA is a major improvement as for example some sunscreen ingredients have been under review for over ten years. Direct Link to SIA is as follows: https://www.congress.gov/bill/113th-congress/senate-bill/2141/text

WISH LISTS

FDA WISH LIST—Congressional Authorization of more resources, i.e. MONEY so FDA can effectively fulfill the mission of the FDCA. 

STAKEHOLDER WISH LIST—More Clarity from FDA!

RECOMMENDATIONS—FDA and the FTC did have major accomplishments as the above examples illustrate. They illustrate the necessity for “an FDA” as well as an “FTC”. Hopefully though the proposed rules will be finalized in 2015 and hopefully Congress will revisit FDA regulatory authority for some products such as dietary supplements where FDA can only legally exercise post-enforcement. Stay tuned for more about the role of FDA and for more food and drug law updates in 2015.