December 15, 2022
Volume XII, Number 349
December 15, 2022
– Private Equity & Healthcare: Antitrust Enforcement in 2023–PE…by: John D.Carroll and Michael G.McKinnon
– CFPB Fall Supervisory Highlights Find Credit Reporting Failures, Junk…by: Moorari Shah and A.J.S.Dhaliwal
– Labor Board Returns to ‘Overwhelming Community of Interest’ Standard…by: Jonathan J.
Spitz and Richard F.Vitarelli
– NLRB Expands Make-Whole Remedy to Include ‘Direct or Foreseeable’…by: C.Thomas Davis and Zachary V.Zagger
– Beyond Backpay: Labor Board Adds Extra Compensation to Employees in ‘…by: Jonathan J.Spitz and Richard F.Vitarelli
– Special Delivery: NLRB Returns to Obama-Era Standard to Limit…
by: Michael J.Lebowich and Joshua S.Fox
– Recent Developments to the 340B Drug Pricing Program [PODCAST] by: Victoria K.Hamscho and Andrew D.
Ruskin
– Festive NLRB Provides Holiday Gifts to Unions/Employees by: Robert E.Entin
– Third Circuit: Whistleblowers Are Not Shielded From Discipline for…by: Steven J Pearlman and Pinchos (Pinny) Goldberg
– Psychedelic Drugs – Easing the Regulatory Hurdles for Development by: Lauren P.Carboni and Devaki Patel
– CFPB and State Regulators Hone in on Interest-Bearing Crypto Accounts by: Moorari Shah and A.J.
S.Dhaliwal
– U.S.Supreme Court to Decide Whether Appeal of Denial of Motion to…by: William Robert Gignilliat, IV and Samia M.
Kirmani
– OCC Revises Policies and Procedures for Civil Money Penalties by: Moorari Shah and A.J.S.
Dhaliwal
– Several New Group Health Plan Reporting Deadlines Are Approaching –…by: Nick J.
Welle and Hannah R.Demsien
– CMS Includes MAOs in Data Exchange and Prior Authorization…by: Christine M.
Clements and Sheela Ranganathan
– Abortion-Related Time Off After Dobbs: How the FMLA and Other Laws…
by: Frank C.Morris, JR and Susan Gross Sholinsky
– Battle Lines Drawn on Electric Vehicle Tax Credit Specifics by: William Ball
– Emerging Threats: Cyber Attacks and Side-Channel Evolution by: Iliana L.Peters and Colin H.Black
– ’Tis the Season for California’s 2023 Legislative Update: Employer…
by: Vanessa C.Krumbein and Rana Ayazi
– Guide to Creating a Corrective Action Plan Template by: Dr.Nick Oberheiden
– Ten Environmental and Energy Issues to Watch in 2023 by: J.Michael Showalter and Amy Antoniolli
– Treasury Announces a Second Application Round for ECIP Investments by: Neil E.Grayson and Robert Klingler
– S.D.N.Y.Voids ERISA Plan’s Arbitration Provision by: Joseph E Clark and Daniel B.Wesson
– Michigan Minimum Wage and Paid Leave Update: Agency Guidance and the…by: Emily M.
Petroski and Allan S.Rubin
– NLRB Reinstates “Micro Unit” Standard Making it Easier for Unions to…by: James J.La Rocca and Robert T.
Dumbacher
– Love and Marriage: How the Respect for Marriage Act Affects Employers…by: J.William Manuel and Anne R.
Yuengert
– DHS Issues Guidance on Additional H-2B Temporary Nonagricultural…
by: Jessica Feinstein
– 12 Days of CRM: Day 1 – How to Measure CRM Success by: Christina R.Fritsch JD
– Staff Says Some Non-GAAP Financial Disclosures Are Beyond Redemptive…by: Keith Paul Bishop
– A Direct Hit: NLRB Expands Make-Whole Remedies to Cover All “Direct…by: Michael J.Lebowich and Joshua S.Fox
– NLRB Dramatically Increases Liability for Unfair Labor Practices with…by: Adam C.
Abrahms and Neresa A.
De Biasi
– False Claims Act: Prediction on Supreme Court Ruling on Government…by: Lori A.Rubin and Pauline R.Wizig
– Proxy Season Greetings: ISS and Glass Lewis Announce Policy Updates…by: Colleen Hart and Andrea S Rattner
– Supreme Court Declines to Clarify FCA Pleading Standard by: Scarlett Singleton Nokes and Virginia C.Wright
– Full Speed Ahead: District Court Entitled to Explore Litigation…
by: Amol Parikh
– Economically Motivated Adulteration in Honey by: Food and Drug Law at Keller and Heckman
– China Announces New Management Measures for Food-Related Products by: David J.Ettinger and Eric Gu
– Ratings Agencies Increase Focus on “Green Ratings” by: Jacob H.
Hupart
– Increased Federal Attention to Skilled Nursing Facility Compliance…by: Anne M.Murphy and Rachel Hold-Weiss
– European Commission to Start Adequacy Decision Adoption Process for…by: Hunton Andrews Kurth’s Privacy and Cybersecurity
– Applying Collateral Estoppel in IPRs by: Alexandra Cavazos, PhD
– Appellate Court Addresses How Much Information Employee Must Submit…
by: Tasos C.Paindiris and David Mohl
– Improving Liquidity Through Real Estate Sale and Leaseback…by: Simone Wijngaard and Alexander van Hövell
– The Ultimate Lawyer Time Off Checklist by: Kamron Sanders
– PTO Announces Cancer Moonshot Expedited Examination Pilot Program by: Bernard P.Codd
– Do Law Firms Use HubSpot? by: CRM News and Updates, Lawmatics
– Litigation Minute: Year in Review—Trending Topics Across the 2022…
by: Lindsay Sampson Bishop and Jacquelyn S.Celender
– The State of ESG Reporting in Australia by: Clive Cachia and Adam Levine
– Supreme Court to Hear Case on Whether Lawsuits are Stayed During…by: Ron Chapman, Jr.and Zachary V.
Zagger
December 14, 2022
– Certain Green Cards Getting 24-Month Extensions as USCIS Deals With…by: Michael H.Neifach
– Ankura CTIX FLASH Update – December 13, 2022 by: Ankura Cyber Threat Investigations and Expert Services
– Australia: Climate and Sustainability-Related Financial Disclosure…by: Jim Bulling
– Ankura CTIX FLASH Update – December 9, 2022 by: Ankura Cyber Threat Investigations and Expert Services
– New Washington State Guidance A Reminder That More State Pay…
by: Aaron Vance
– Washington Supreme Court Affirms Ecology’s Authority to Bypass…by: Erika H.
Spanton and Allyn L.
Stern
– NLRB Unleashes New Damages Against Labor Law Violators by: Mark J.
Neuberger
– Illinois Appellate Court Weighs in on Biometric Data Policies by: David M.Poell and Kari M.Rollins
– FTC Issues Green Guides Questionnaire by: Phyllis H.Marcus
– Traveling for the Holidays: Planning for Successful International…by: Ann H.Lee and Michael J.
Bonsignore
– NYC Council Considering Proposal To Significantly Limit At-Will…by: Evandro C Gigante and Joseph C O’Keefe
– Webinar Recording: Navigating Today’s Privacy Compliance…by: Cynthia J.Larose
– Pennsylvania Takes Emergency Action to Regulate Conventional Oil…by: David J.Raphael and Brianna K.Edwards
– A Look At The Upcoming European Unitary Patent And Unified Patent…
by: Angela B.Freeman, M.S.and Rory P.
Pheiffer
– Massachusetts Unveils New Workplace Poster, Notifications for…by: Rachel Reingold Mandel and Ashley Prickett Cuttino
– US Executive Branch Update – December 14, 2022 by: Stacy A.Swanson
– Michigan Court of Appeals Hears Argument on the Adopt and Amend…by: Luis E.
Avila and Maureen Rouse-Ayoub
– California Wage and Hour Issues for Employers to Watch in 2023: Is My…by: Karen E.Wentzel and Michael W.
Kelly
– AML Bill Key to Busting Russian Oligarchs by: Stephen M.Kohn and Grace Schepis
– SEC and CFTC Whistleblower Programs Reveal Continued Success…by: Jason Zuckerman and Matthew Stock
– Prices Keep Rising: Labor Board Significantly Expands Remedies…by: David J.Pryzbylski and Aaron Vance
– More on Understanding the Medicare Overpayment Appeals Process by: Kendall R.
Walker and Courtney G.Tito
– New York State Provides Protection for Use of Leaves of Absence by: Jonathan A.Wexler
– US Executive Branch Update – December 13, 2022 by: Stacy A.Swanson
– Looking Ahead to 2023: Pay Transparency Developments by: Allan S Bloom and Evandro C Gigante
– What Does 2023 Hold for California COVID-19 Supplemental Paid Sick…by: Benjamin A.Tulis
– AND ANOTHER ONE! TCPA CLASS DISCOVERY LIMITED: Third Party Subpoena…
by: Jenniffer Cabrera
– Reminder: New Tax Forms for Retirement Plan Payment Withholding…by: Jeffrey M.
Holdvogt and Diane M.Morgenthaler
– Ninth Circuit Answers Lingering Question on Scope of ‘Autodialer…by: Joseph C.Wylie II and Nicole C.Mueller
– Speak Out Act Takes Effect, Enhanced Data Privacy Obligations for…by: George Carroll Whipple, III
– Preparing for New SBA Certification Requirements for Veteran-Owned…by: Erin L.Toomey and Frank S.
Murray
– California Starts Mandating Employee Bereavement Leave in 2023 by: Paul R.Lynd
– HHS Bulletin: Covered Entities’ Disclosure of PHI Collected via…by: Ryan P.Blaney and Danielle L.Brooks
– When 2 Minus 1 Still Equals 2: Combining Lots in a Planned Community by: Dana M.Lingenfelser and Kristin D.Mitcham
– GREAT LEGAL WORK: TCPA Defendant Wins a HUGE Certification Victory…by: Eric J.
Troutman
– 401(k) Compliance Check #12: Don’t Borrow Trouble – Correcting…by: Belinda S.Morgan
– FDA Published Food Safety Culture Literature Review by: Food and Drug Law at Keller and Heckman
– Does a business have to provide a privacy notice directly to a…by: David A.Zetoony
– New Privacy Enforcement Act Commences in Australia by: Cameron Abbott and Rob Pulham
– NYC Delays Enforcement of Automated Employment Decision Tools Law to…by: Lindsay Colvin Stone
– U.S.
Department of State to Update Design on Nonimmigrant and…by: Ashley K.
Kerr
– Cannon Fire: Newly-Famous Judge Stays All Discovery in TCPA Class…by: Eric J.Troutman
– EPA Announces Proposed RFS for 2023-2025, Will Hold Public Hearing in…by: Lynn L.
Bergeson and Carla N.Hutton
– Why Do Law Firms Need CRM? by: CRM News and Updates, Lawmatics
– This California Rule by: Keith Paul Bishop
– Unintended Consequences: Legal Compliance Concerns With Long-Term…by: Amber K.Dodds and Robert S.
Nichols
– UK Parliament Considers Retained EU Law (Revocation and Reform) Bill…by: Emma Thomson
December 13, 2022
– DOL Issues Final Rule Amending Investment Duties Regulation –…by: James Frazier
– Third time lucky or Schrems III? The European Union Data Pact with…by: Diletta De Cicco and James Downes
– Renewed Era of Crypto Assets Growth in Hong Kong by: Jay Lee
– Division I Universities Must Be Ready for Changes to the NCAA…by: Paul V.Kelly
– U.S.Supreme Court Hears Oral Argument in Case Testing Limits of…by: Michelle E.
Phillips and Christopher M.Repole
– Damages in Pre-Certification Discovery are Premature, Discovery…by: Jenniffer Cabrera
– When Chains Change, Do NFTs Stay The Same? How Hard Forks May Affect…by: Jason H.Finger
– COVID-19: A Roadmap to Fraud Investigations: Office of Inspector…by: Stephen D.Bittinger
– DOJ Settlement with Electronic Health Records Provider Highlights…by: Ty E.
Howard and Lane M.Webster
– Update: OFCCP Plans to Disclose EEO-1 Data for Non-Objecting…by: Abby M.Warren
– Increasing US Enforcement Action for Sanctions Violations by Crypto…
by: Hannah Laming and Adam Klauder
– DOJ Antitrust Division and HHS OIG Enter into Partnership to Increase…by: Diane Hazel
– Can Discovery Be Compelled from a Party? Possession, Custody, Control…
by: Kathryn C.Cole
– Weekly Bankruptcy Alert December 13, 2022 by: Bankruptcy & Creditors’ Rights
– California’s Newly Adopted “Safe Harbor” Warning Label for Acrylamide…by: Taryn McPherson and Whitney Jones Roy
– Considerations for Public Company Bylaw Amendments in View of the New…by: Frank M.
Placenti and Doron Lipshitz
– All Things Chemical® Podcast: TSCA Regulation of Articles: The Saga…by: Lynn L.
Bergeson
– Telecom Alert: Providers Support 10-10.5 GHz NPRM; FCC Blocks Student…by: Jaimy “Sindy” Alarcon and Jim Baller
– New DOL Rule Enables Consideration of ESG Factors in Investing, Plus…by: Johnjerica Hodge and Danette R.Edwards
– Energy & Sustainability M&A Activity — December 2022 by: Thomas R.
Burton, III and Sahir Surmeli
– Court Holds NC State Health Plan Constitutes “Health Program or…by: Caroline Turner English and Alison Lima Andersen
– Energy & Sustainability IP Updates — December 2022 by: Brad M.Scheller
– Another Block Falls: BlockFi Files for Chapter 11 Protection,…by: David A.
Lopez-Kurtz and Alex J.Albers
– SEC Reopens Proposal on Stock Buyback Rules by: Erin Reeves McGinnis
– IRS Announces 2023 Increases to Estate and Gift Tax Exclusions by: Katlyn E.
Koegel and Stephen C.Rohr
– FDA Letter States that β-Nicotinamide Mononucleotide is Not Lawful…
by: Food and Drug Law at Keller and Heckman
– New York City’s Automated Employment Decision Tools Law Enforcement…by: Adam S.Forman and Nathaniel M.
Glasser
– Chips Chatter: December 5-12, 2022 by: Pablo E.Carrillo and Ludmilla L.Kasulke
– FTC Releases Tentative Agenda for December 14 Open Commission Meeting by: Hunton Andrews Kurth’s Privacy and Cybersecurity
– How Many Behavioral Advertising Trackers Do Websites Deploy Currently? by: David A.Zetoony
– FRB Proposes Climate-Related Financial Risk Management Principles by: Daniel Meade
– Energy & Sustainability Litigation Updates — December 2022 by: Jacob H.Hupart
– Investor-State Arbitration: 2022 ICSID Rule Amendments and Update on…
by: Joseph J.Mamounas and Claudia D.
Hartleben
– Warning Sign? A New Round of FDA Warning Letters Over CBD Consumer…by: J.Hunter Robinson and Josh Kleppin
– Cross Border Recognition, 25 years on: the view from each side of the…by: Michelle N.Saney
– A New Era of Technology in the Private Markets by: Louis Lehot and Christopher Converse
– New York City Postpones Enforcement of Automated Employment Decision…by: Simone R.D.
Francis
– New Law Seeks To Curtail Coerced Debts by: Keith Paul Bishop
– Republican SEC Commissioners Continue to Criticize Proposed Climate…by: Jacob H.Hupart
Psychedelic Drugs – Easing the Regulatory Hurdles for Development
Congress recently introduced a bill that could expand access to therapeutic psychedelics that are designated as Breakthrough Therapies.These products are potentially useful in treating addiction, depression, post-traumatic stress disorder (PTSD), and other neurologic diseases.
In recognition of the need to fulfill research and development requirements of certain Schedule I psychedelics, the Drug Enforcement Agency (DEA) also significantly increased the production quota in the manufacturing of N,N-Dimethyltryptamine (DMT), 3,4-methylenedioxymethamphetamine (MDMA), lysergic acid diethylamide (LSD), and other drugs.These actions are exemplary of the federal government’s shift in its approach to the therapeutic value of psychedelic substances.
Breakthrough Therapies Act
On November 17, 2022, U.S.Senators Cory Booker (D-N.J.) and Rand Paul (R-KY) introduced the Breakthrough Therapies Act, a bipartisan bill that, if passed, would permit the DEA to reclassify a Schedule I drug – defined by the DEA as a drug with “no currently accepted medical use and a high potential for abuse” – that receives a Breakthrough Therapy Designation from the Food and Drug Administration (FDA) to a Schedule II drug under the federal Controlled Substances Act (CSA).Currently, psychedelics, such as LSD, MDMA, psilocybin, and others, are classified as Schedule I substances.
Under the FDA’s expedited drug development initiatives, a Breakthrough Therapy Designation affords a company with the opportunity to have greater interaction with FDA to expedite the development and review of drugs that are intended to treat a serious condition and clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).” To date, the FDA has designated two Schedule I psychedelics as Breakthrough Therapies: (i) psilocybin-assisted therapy to treat severe treatment-resistant depression and major depressive order (ii) MDMA-assisted therapy to treat moderate to severe PTSD.
In a press release, Senator Booker stated the law “could help facilitate a phased roll-out of these potentially lifesaving therapies via FDA-approved Expanded Access pilot programs” and it “would remove burdensome federal regulations that impede research and development of drugs that may be inappropriately listed in Schedule I.”
Key takeaways from the Breakthrough Therapy Act include the following:
It amends the CSA to create an administrative process by which current Schedule I drugs that are deemed “breakthrough therapies” by the FDA or qualify for a waiver under the federal Food, Drug, and Cosmetic Act (FD&C Act) can be reclassified as a Schedule II drug – defined as drugs with “currently accepted medical use with severe restrictions.”
Researchers with existing Schedule I or II research registrations with DEA can conduct studies involving Schedule I drugs 30 days after sending a notice to the Attorney General containing required information about their research including the chemical name of the substance and the quantity of the substance to be used in the research.
Researchers without a current Schedule I or II research registrations with DEA can send a notice to the Attorney General containing the required information about their research in which the Attorney General would treat such notice as a sufficient application for a research registration.
In this case, the Attorney General would have to render a decision within 45 days of receiving the notice.
The Breakthrough Therapies Act was referred to the Senate Judiciary Committee.No further actions have occurred, but we will continue to monitor the bill’s progress.Notably, the bill was introduced around the same time as Congress’s announcement of the bipartisan Congressional Psychedelics Advancing Clinical Treatments (PACT) Caucus which will focus on exploring psychedelic research to alleviate the U.S.mental health crisis.
DEA Increases 2023 Aggregate Production Quota of Schedule I Drugs
The DEA substantially increased the 2023 aggregate production quotas (APQ) for certain psychedelics to be used in research.
This signifies an increased demand for federal research and clinical trials on the therapeutic use of psychedelics.In the December 2, 2022 final rule, the DEA significantly increased the manufacturing APQs for MDMA, psilocin (a psychedelic substance found in psilocybin mushrooms), 5-Methoxy-N,N-dimethyltyptamine (5-MeO-DMT), methylenedioxyamphetamine (MDA), and LSD as follows:
Scheduled Substance
2022 Quota
2023 Quota
5-MeO-DMT,
2,550 grams
11,000 grams
LSD
500 grams
1,200 grams
Psilocin
4,000 grams
12,000 grams
MDA
200 grams
12,000 grams
MDMA
3,200 grams
12,000 grams
Notably, the APQ for psilocybin remains the same as the 2022 quota, at 8,000 grams.
In responding to commenters requesting the DEA consider increasing APQs for certain Schedule I psychedelics (i.e., 5-MEO-DMT, DMT, MDA, MDMA, 2-CB, psilocin, and psilocybin) the DEA responded that the APQs established in the final rule reflect DEA’s estimates of the medical, scientific, research, and industrial needs for 2023.However, such APQs can be adjusted if those needs change.
For example, if DEA receives additional research protocols from DEA-registered researchers or additional quota applications from DEA-registered manufacturers.
Lastly, the DEA welcomes further engagement with representatives from indigenous communities to determine APQs for controlled substances that are potentially derived from plants traditionally used by such communities in the U.S.and beyond.The DEA also stated that the APQs manufacturing quotas are informed, in part, by the quota requests submitted by DEA-registered manufacturers of those substances, and the current needs of indigenous communities may be reflected in the requests DEA has received.DEA’s position suggests there is a great opportunity to ensure the indigenous community, who has been using certain entheogen plants for centuries for therapeutic purposes, is a stakeholder in the future of the psychedelics industry.The recent resurgence of psychedelics, and its likely imminent commercialization, poses a real threat to the sustainability of plant-derived psychedelics and those communities who are the keepers/utilizers of those plants.A failure to include the indigenous communities will likely have dire consequences on the psychedelic industry.
Based on these recent strides by the federal government, firms operating in the psychedelics drug market may experience less obstacles in the regulatory approval pathway for their psychedelic drug products in the coming years ahead.Notwithstanding, please remember that companies and investigators must still comply with significant regulatory requirements in order to obtain, secure and conduct research on these potentially very beneficial psychedelic substances..