The Food and Drug Administration (FDA) issued emergency use authorization for three vaccines to protect against COVID-19. While these long-awaited vaccines have provided tremendous hope for the nation in looking for a pathway out of the pandemic,... Read More
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
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
It is a challenging task to open and sustain an independent, retail pharmacy business, particularly given the current landscape. However, even more challenging, is establishing a pharmacy in a “HEAT Zone.” The Health Care Fraud Prevention and... Read More
On February 4, 2021, the Attorneys General of 47 states announced a $573 million joint settlement with the global consulting firm McKinsey & Company. The settlement, in which McKinsey did not admit wrongdoing, was predicated on McKinsey’s... Read More
The Department of Justice (“DOJ” or the “Government”) and Bartell Drug, Inc. (“Bartell”), a Washington State pharmacy chain of approximately 70 pharmacies, recently reached a civil settlement in which Bartell agreed to pay a fine... Read More
As the opioid crisis continues to result in devastating consequences throughout the country, the U.S. Department of Justice (the “DOJ”) is broadening its opioid enforcement to all stakeholders involved in the opioid supply chain including,... Read More
Compounding pharmacies should be aware of recent developments in the law surrounding bioidentical hormone therapy (cBHT). In the field of pharmacy, compounding (performed in compounding pharmacies) is preparation of a custom formulation of a... Read More
The FDA has delayed the verification of salable returns requirement under the Drug Supply Chain Security Act (DSCSA) until November 27, 2023. On October 22, 2020, FDA released a Guidance delaying enforcement of the provision that requires wholesale... Read More
Frier Levitt Co-Founding Partner Daniel B. Frier recently summarized a variety of ways in which providers can become ensnarled in fraudulent schemes disguised as legitimate business models. Since the publication of that article, a significant... Read More
