On May 21, 2025, the Connecticut Office of the Attorney General released a statement and sent letters to Connecticut weight loss clinics, med spas, medical practices and other businesses regarding allegedly or potentially...more
6/6/2025
/ Consumer Protection Laws ,
Drug Compounding ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Health Care Providers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Requirements ,
State Attorneys General ,
Unfair or Deceptive Trade Practices
On March 5, 2025, one U.S. District Court ruled unequivocally in the Food & Drug Administration’s (FDA) favor in the case, Outsourcing Facilities Ass’n, et. al. v. U.S. Food and Drug Admin., et. al., 4:24-cv-0953-P, slip op.,...more
3/13/2025
/ Appeals ,
Drug Compounding ,
Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Pharmaceutical Industry ,
Pharmacies ,
Preliminary Injunctions ,
Prescription Drugs ,
Regulatory Requirements
On December 19, 2024, the U.S. Food and Drug Administration (FDA) issued a Declaratory Order reevaluating and re-confirming that the tirzepatide drug shortage has been resolved. This order revoked and replaced FDA’s October...more
What Are ADCs and Why Are They Growing?
Over the past few years economic headwinds have resulted in fewer deals, with companies and private equity firms alike reassessing where to spend money. But one portion of the...more
Less than a week after the U.S. Food & Drug Administration (FDA) determined that the shortage of the tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been “resolved” and removed from the FDA’s shortage...more
On Friday, January 5, 2024, in a major policy shift, the U.S. Food & Drug Administration (FDA) authorized Florida’s Agency for Health Care Administration’s plan to purchase medicines in bulk for its Medicaid programs,...more
On November 16, 2021, U.S. House Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) introduced the highly anticipated Cures 2.0 Act (H.R. 6000). Among other things, this 173-page bipartisan bill contain provisions to...more
On August 6, 2020, President Trump signed an Executive Order (“Order”) to ensure essential medicines, medical countermeasures, and critical inputs are made in the United States. The President recognized that reliable...more
9/10/2020
/ Administrative Procedure Act ,
APIs ,
Department of Health and Human Services (HHS) ,
Essential Drug List ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Personal Protective Equipment ,
Prescription Drugs ,
Public Health Emergency ,
Stafford Act ,
Supply Chain ,
Trade Agreements
In the wake of the COVID-19 pandemic, the FDA has sought to expand the availability of needed personal protective equipment (PPE) for the general public and healthcare professionals. Recently, for example, FDA published two...more
4/7/2020
/ 510(k) RTA ,
Affordable Care Act ,
Centers for Disease Control and Prevention (CDC) ,
Department of Health and Human Services (HHS) ,
Enforcement ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medicaid ,
Medical Devices ,
Medicare ,
Personal Protective Equipment ,
Prescription Drugs
As the coronavirus outbreak continues to wreak havoc on markets and industries in the U.S. and around the world, businesses are now confronting significant and unique challenges. Successful navigation of these challenges...more
During his speech last month to a joint session of Congress, President Trump called out the U.S. Food and Drug Administration for its “slow and burdensome approval process.” Those comments came on the heels of Trump’s...more
3/30/2017
/ Budget Cuts ,
Drug Approvals ,
Federal Budget ,
Food and Drug Administration (FDA) ,
Health & Safety Standard ,
Life Sciences ,
Medical Devices ,
Medical Research ,
OMB ,
Pharmaceutical Industry ,
Prescription Drugs ,
Trump Administration ,
User Fees
Price increases threatening the availability of EpiPen® and EpiPen Jr® Auto-Injectors (“EpiPen”) have touched off the latest firestorm over drug pricing. Lost amid the public outcry, however, is a thorny regulatory issue:...more
9/21/2016
/ Abbreviated New Drug Application (ANDA) ,
Centers for Medicare & Medicaid Services (CMS) ,
Classification ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Legislative Agendas ,
Manufacturers ,
MDRP ,
Medicaid ,
Medicare ,
Prescription Drugs ,
Rebates
Following months of public outcry and Congressional probes into significant drug price increases, the Senate Judiciary Committee introduced legislation targeting “behavior that blocks competition and delays the creation of...more
7/6/2016
/ Antitrust Litigation ,
Biosimilars ,
Drug Pricing ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Injunctive Relief ,
Pharmaceutical Industry ,
PHRMA ,
Prescription Drugs ,
Price Transparency ,
Proposed Legislation ,
REMS ,
Research and Development ,
Senate Judiciary Committee
The Food and Drug Administration’s (FDAs) Arthritis Advisory Committee gave a thumbs up to a biosimilar copy of Johnson & Johnson’s Remicade product, an inflammation blocker used in the treatment of rheumatoid arthritis, on...more
2/12/2016
/ Advisory Committee ,
Amgen ,
Biologics ,
Biosimilars ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Johnson & Johnson ,
Patent Litigation ,
Pharmaceutical Industry ,
Prescription Drugs ,
Sandoz
On August 27, 2015, the Food and Drug Administration (FDA) released draft guidance on nonproprietary naming of biological products. The agency’s draft guidance proposes that the core nonproprietary name for originator...more
In Federal Trade Commission v. Actavis, Inc., No. 12-416, 2013 U.S. LEXIS 4545 (U.S. June 17, 2013), the U.S. Supreme Court reversed the Eleventh Circuit decision in FTC v. Watson Pharmaceuticals, Inc., 677 F.3d 1298 (2012),...more
6/19/2013
/ Abbreviated New Drug Application (ANDA) ,
Actavis Inc. ,
Federal Trade Commission (FTC) ,
FTC v Actavis ,
Generic Drugs ,
Patents ,
Pay-For-Delay ,
Pharmaceutical Industry ,
Prescription Drugs ,
Reverse Payment Settlement Agreements ,
SCOTUS