Thirty-seven years after enactment of the Hatch Waxman Act 2, it remains difficult for Congress, and the drug supply chain industry to strike the appropriate balance of legal rights between brand name and generic drug manufacturers as it relates to... Read More
Blogs & Articles | Intellectual Property Services | Life Sciences | Manufacturers | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA

Traditionally, generic drug companies have been able to obtain FDA approval for less than all of the FDA approved indications of a drug, a “carve out” commonly referred to as a “skinny label.” A safe harbor currently allows generic... Read More
Blogs & Articles | Life Sciences | Manufacturers | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA

Some PBMs require that pharmacies purchase diabetic testing supplies from “authorized distributors.” While the term varies from manufacturer to manufacturer, an authorized distributor is essentially an approved wholesaler that is contracted with... Read More
Blogs & Articles | Life Sciences | Manufacturers | Pharmaceutical Wholesalers

The Office of the Inspector General for Health and Human Services (OIG) issued a comprehensive review of the effectiveness of the Food and Drug Administration’s (FDA) Risk Evaluation and Mitigation Strategy (REMS) for certain opioid-based drugs.... Read More
Chain Pharmacies | Life Sciences | Manufacturers | White Collar Defense and Government Investigation

As Coronavirus (COVID-19) cases continue to plateau and as the nation experiences the benefit of social distancing, the focus has quickly turned to the development of a vaccine.  Promising Vaccines Despite the substantial cost of developing,... Read More
Blogs & Articles | COVID-19 Resources | Healthcare Law | Life Sciences | Manufacturers | Pharmacy Law

Wholesale drug distributors need to maintain adequate track and trace documents, especially when acquiring and distributing COVID-19 therapies. The COVID-19 epidemic has sparked a demand for various drug products including, hydroxychloroquine. To... Read More
Blogs & Articles | COVID-19 Resources | Life Sciences | Manufacturers | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA

U.S. Attorneys in the Southern District of Georgia recently charged the operator of a durable medical equipment company with conspiring to pay kickbacks to physicians in exchange for obtaining DME orders. This action reaffirms the Department of... Read More
Blogs & Articles | Employment Matters | Healthcare Law | Healthcare Litigation | Life Sciences | Manufacturers | Telehealth and Telemedicine | Telehealth and Telemedicine