On May 7, 2025, the US District Court for the Northern District of Texas upheld the US Food and Drug Administration’s (FDA’s) decision to remove two tirzepatide injection medications from the FDA’s drug shortage list. This...more
6/13/2025
/ Appeals ,
Drug Compounding ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Reform ,
Judicial Authority ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
Regulatory Reform ,
Regulatory Requirements ,
Supply Shortages
On February 21, 2025, the US Food and Drug Administration (FDA) revised its shortage categorization of semaglutide, a glucagon-like peptide 1 (GLP-1) medication, marking the shortage as “resolved” for all presentations of the...more
The US Drug Enforcement Administration (DEA) further extended flexibilities that allow providers to prescribe controlled substances via telemedicine without first performing an in-person visit. The flexibilities were...more
11/19/2024
/ Controlled Substances ,
Coronavirus/COVID-19 ,
DEA ,
Department of Health and Human Services (HHS) ,
Extensions ,
Healthcare ,
Prescription Drugs ,
Public Health Emergency ,
Regulatory Agenda ,
Telehealth ,
Telemedicine ,
Temporary Regulations
On October 3, 2024, the US Food and Drug Administration (FDA) revised its shortage categorization of tirzepatide, a glucagon-like peptide 1 (GLP-1) medication, marking the shortage as “resolved” for all presentations of the...more
10/10/2024
/ Drug Compounding ,
Food and Drug Administration (FDA) ,
Goods or Services ,
Healthcare ,
Life Sciences ,
Patient Access ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Supply Chain ,
Supply Shortages
The United States Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) have further extended flexibilities that allow providers to prescribe controlled substances...more
10/9/2023
/ Controlled Substances ,
Coronavirus/COVID-19 ,
DEA ,
Extensions ,
Healthcare ,
Prescription Drugs ,
Public Health Emergency ,
SAMHSA ,
Telehealth ,
Telemedicine ,
Temporary Regulations
McDermott’s digital health team continually monitors legal developments affecting all aspects of the remote delivery of care. This inaugural issue of our Of Digital Interest Quarterly Roundup highlights key issues and trends...more
4/28/2023
/ Banking Sector ,
Controlled Substances ,
DEA ,
Digital Health ,
Financial Crisis ,
Health Care Providers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules ,
Regulatory Agenda ,
Rulemaking Process ,
Silicon Valley ,
State and Local Government ,
Telehealth ,
Telemedicine
On February 24, 2023, the US Drug Enforcement Administration (DEA) issued two proposed rules (the Telemedicine Controlled Substance Proposed Rule and the Telemedicine Buprenorphine Proposed Rule) that would establish...more
On January 12, 2023, the US Drug Enforcement Administration (DEA) released a letter to registrants announcing DEA’s support of Congress’s recent removal of the requirement that healthcare providers possess a DATA-Waiver,...more
On July 20, 2022, the US Department of Health and Human Services Office of Inspector General (OIG) issued a Special Fraud Alert (Alert) concerning the fraud and abuse risks associated with healthcare practitioners entering...more
1/4/2023
/ Controlled Substances ,
Criminal Investigations ,
Department of Health and Human Services (HHS) ,
Fraud ,
Health Care Providers ,
Medicaid ,
Medicare ,
OIG ,
Prescription Drugs ,
Telehealth ,
Telemarketing ,
Telemedicine
On July 20, 2022, the US Department of Health and Human Services Office of Inspector General (OIG) issued a Special Fraud Alert (Alert) concerning the fraud and abuse risks associated with healthcare practitioners entering...more
7/28/2022
/ Controlled Substances ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Kickbacks ,
Medicaid ,
Medicare ,
OIG ,
Prescription Drugs ,
Telehealth ,
Telemarketing ,
Telemedicine
The US Drug Enforcement Administration (DEA) stated in an FAQ on its website that prescribers may issue prescriptions for controlled substances based on a telemedicine encounter in the absence of an in-person medical...more