On April 30, 2024, the Associated Press (AP) reported the Drug Enforcement Administration (DEA) will propose a rule to reschedule cannabis from Schedule I to Schedule III under the Controlled Substances Act (CSA). More...more
5/14/2024
/ Administrative Procedure Act ,
Biden Administration ,
Cannabis Products ,
Controlled Substances ,
Controlled Substances Act ,
DEA ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Final Rules ,
Food and Drug Administration (FDA) ,
IRS ,
Judicial Review ,
Marijuana ,
Medical Marijuana ,
Notice and Comment ,
NPRM ,
OMB ,
Popular ,
Regulatory Reform ,
Schedule I Drugs
The Federal Trade Commission (FTC) has been busy scrutinizing patent listings in the Food and Drug Administration’s (FDA) publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the...more
5/13/2024
/ Competition ,
Federal Trade Commission (FTC) ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
FTC Act ,
Generic Drugs ,
Healthcare ,
Life Sciences ,
Orange Book ,
Patents ,
Pharmaceutical Patents ,
Section 5
Another aspiring cannabis license applicant has filed a lawsuit against the Maryland Cannabis Administration (MCA) and is seeking an injunction that could further delay the issuance of new adult-use cannabis licenses in...more
This is the sixth in our 2024 Year in Preview series examining important trends in white collar law and investigations in the coming year. We will be posting further installments in the series throughout the next several...more
3/8/2024
/ China ,
Corporate Governance ,
Critical Infrastructure Sectors ,
Drug Pricing ,
Educational Institutions ,
Energy Projects ,
Environmental Social & Governance (ESG) ,
Healthcare ,
Legislative Agendas ,
Medicare Advantage ,
New Legislation ,
New Regulations ,
Pharmaceutical Industry ,
Private Equity ,
Regulatory Agenda ,
Social Media ,
Supply Chain ,
Supply Shortages ,
White Collar Crimes
We have an update about the recent lawsuit challenging the constitutionality of the Maryland Cannabis Administration’s (MCA’s) Social Equity Program.
To recap, on January 26, 2024, a California-based attorney filed suit...more
3/1/2024
/ Cannabis Products ,
Cannabis-Related Businesses (CRBs) ,
Constitutional Challenges ,
Dismissals ,
Legislative Agendas ,
Licenses ,
Licensing Rules ,
Marijuana ,
Marijuana Related Businesses ,
Maryland ,
Preliminary Injunctions ,
Social Equity Programs ,
State and Local Government
According to a Complaint filed on January 26, 2024, in the United States District Court for the District of Maryland, Maryland's adult-use cannabis licensing program, which is currently limited to applicants who qualified for...more
2/28/2024
/ Cannabis Products ,
Cannabis-Related Businesses (CRBs) ,
Commercial Litigation ,
Dormant Commerce Clause ,
Licenses ,
Licensing Rules ,
Marijuana ,
Marijuana Related Businesses ,
Maryland ,
Social Equity Programs ,
State and Local Government
The Federal Trade Commission (FTC) and the Department of Health and Human Services (HHS) are soliciting public comments on the root causes of and potential solutions to drug shortages. The request for information (RFI)...more
The 2024 adjusted HSR threshold is $119.5 million and goes into effect on March 6, 2024. All transactions valued below that amount will be exempt from the HSR filing requirement.
The 2024 adjusted Size of Party thresholds...more
2/6/2024
/ Acquisitions ,
Antitrust Division ,
Civil Monetary Penalty ,
Federal Trade Commission (FTC) ,
Filing Fees ,
Hart-Scott-Rodino Act ,
Interlocking Directorate ,
Mergers ,
Pre-Merger Filing Requirements ,
Premerger Notifications ,
Size of Persons Test ,
Size of Transaction Test ,
Threshold Requirements
Virginia’s HSA 1 Pharmaceutical Processor Permit -
Effective January 1, 2024, the Virginia Cannabis Control Authority (CCA) assumed regulatory oversight of Virginia’s medical cannabis program. The CCA was established in...more
Congressional Activity -
The challenges around addressing health concerns related to per- and polyfluoroalkyl substances (PFAS) are immense. The Environmental Protection Agency (EPA) states that PFAS are widely used, long...more
Maryland Releases Cannabis License Application Details and Instructions-
On October 13, the Maryland Cannabis Administration (MCA) released some much-anticipated details regarding the upcoming cannabis licensing round. The...more
10/18/2023
/ Agribusiness ,
Applications ,
Cannabis Products ,
Cannabis-Related Businesses (CRBs) ,
Dispensaries ,
Legislative Agendas ,
Licenses ,
Marijuana ,
Marijuana Related Businesses ,
Maryland ,
Regulatory Agenda ,
Social Equity Programs ,
State and Local Government
On Friday, September 8, the Maryland Cannabis Administration (MCA) Office of Social Equity released additional information for its upcoming initial licensing round, including the social equity verification portal, application...more
9/14/2023
/ Agribusiness ,
Cannabis Products ,
Cannabis-Related Businesses (CRBs) ,
Legislative Agendas ,
Licenses ,
Marijuana ,
Marijuana Related Businesses ,
Maryland ,
New Legislation ,
Proposed Legislation ,
Social Equity Programs ,
State and Local Government
The Maryland Cannabis Administration (MCA) and the Office of Social Equity (OSE) have released the eligibility criteria to be considered a social equity applicant for the upcoming Fall 2023 Cannabis License Application Period...more
9/5/2023
/ Business Licenses ,
Cannabis Products ,
Cannabis-Related Businesses (CRBs) ,
Dispensaries ,
Legislative Agendas ,
Licenses ,
Marijuana ,
Marijuana Related Businesses ,
Maryland ,
State and Local Government ,
State Legislatures
Adult-use cannabis is now legal and available in Maryland, but as so often happens, a group of businesses have filed a lawsuit because they do not like the way legalization has been implemented. Led by the Maryland Hemp...more
8/2/2023
/ Agribusiness ,
Alcohol Beverage Control ,
Cannabis Products ,
Cannabis-Related Businesses (CRBs) ,
Farmers ,
Hemp ,
Hemp Cultivation ,
Hemp Related Businesses ,
Licensing Rules ,
Marijuana ,
Marijuana Related Businesses ,
State and Local Government
With more than $10 million in retail sales during its opening weekend and more than $20 million in retail sales during the first week, Maryland’s adult-use cannabis market is open for business. Nearly 100 of Maryland’s...more
7/19/2023
/ Business Licenses ,
Cannabis Products ,
Cannabis-Related Businesses (CRBs) ,
Dispensaries ,
Legislative Agendas ,
Licensing Rules ,
Marijuana ,
Marijuana Cultivation ,
Marijuana Related Businesses ,
Medical Marijuana ,
State and Local Government
Last week the Maryland Cannabis Administration (MSA) released its draft emergency regulations for the state’s adult-use marijuana market which is set to come online on July 1. The draft regulations are subject to review by...more
5/31/2023
/ Cannabis Products ,
Cannabis-Related Businesses (CRBs) ,
Dispensaries ,
Legislative Agendas ,
Licenses ,
Marijuana ,
Marijuana Related Businesses ,
Maryland ,
Medical Marijuana ,
New Legislation ,
Proposed Legislation ,
Regulatory Authority ,
State and Local Government
In recent years, the FTC has increasingly focused on protecting consumers’ access to healthcare, through both its competition and its consumer protection missions. Similarly, the FTC has become a force in federal privacy...more
Maryland House Bill 556 (cross-filed with Maryland Senate Bill 516), introduced on February 3, 2023, contains essential provisions for any person or entity interested in participating in the cannabis industry in Maryland....more
4/10/2023
/ Agribusiness ,
Business Licenses ,
Cannabis Products ,
Cannabis-Related Businesses (CRBs) ,
Dispensaries ,
Legislative Agendas ,
Marijuana ,
Marijuana Related Businesses ,
Proposed Legislation ,
Social Equity Programs ,
State and Local Government ,
State Legislatures
Significant changes to DC’s medical cannabis program are currently unfolding after the Medical Cannabis Amendment Act of 2022 (MCA) went into effect last month. Previously, DC’s medical cannabis program licensed dispensaries,...more
Maryland House Bill 556 (cross-filed with Maryland Senate Bill 516), introduced on February 3, 2023, contains essential provisions for any person or entity interested in participating in the cannabis industry in Maryland....more
3/15/2023
/ Agribusiness ,
Cannabis Products ,
Cannabis-Related Businesses (CRBs) ,
Clinical Laboratory Testing ,
Legislative Agendas ,
Licenses ,
Marijuana ,
Marijuana Related Businesses ,
Maryland ,
Medical Marijuana ,
New Legislation ,
Proposed Legislation ,
Regulatory Authority ,
Social Equity Programs ,
State and Local Government ,
Testing Requirements
On January 23, 2023, the Federal Trade Commission (FTC) announced its annual adjustment of the jurisdictional thresholds for pre-merger notification filings under the Hart‐Scott‐Rodino Antitrust Improvements Act of 1976 (HSR...more
1/25/2023
/ Acquisitions ,
Civil Monetary Penalty ,
Department of Justice (DOJ) ,
Federal Trade Commission (FTC) ,
Filing Requirements ,
Hart-Scott-Rodino Act ,
Inflation Reduction Act (IRA) ,
Interlocking Directorate ,
Mergers ,
Pre-Merger Filing Requirements ,
Size of Persons Test ,
Size of Transaction Test ,
Threshold Requirements
In the single largest enforcement event in the history of Section 8 of the Clayton Act, it was recently revealed that seven directors have resigned from the corporate boards of five public companies in response to the Justice...more
Transactions involving private equity should expect to face antitrust concerns from the DOJ that go beyond the question of how many competitors will remain afterwards, even if the transactions do not trigger an HSR filing....more
Medical Cannabis in the DMV Continuing this year’s trend of increased access to legal cannabis in the Maryland, DC and Virginia area that started with Maryland adding legalization to the ballot in November, DC and Virginia...more
7/12/2022
/ Cannabis Products ,
Cannabis-Related Businesses (CRBs) ,
Decriminalization of Marijuana ,
Dispensaries ,
Legislative Agendas ,
Marijuana ,
Marijuana Related Businesses ,
Medical Marijuana ,
New Legislation ,
Pharmaceutical Industry ,
State and Local Government
The Maryland Senate has now approved legislation that puts a referendum before voters this November on whether Maryland should legalize adult-use cannabis and begin implementing a regulatory framework if the ballot question...more