The refusal to provide comparator products violates federal and state antitrust laws and the CREATES Act. Although the Supreme Court has expressed caution about imposing antitrust liability based on a monopolist’s unilateral refusal to deal, the... Read More
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
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
HHS Permits Out-of-State Telehealth Providers to Render Certain Services Nationwide On December 3, 2020, the Department of Health and Human Services (“HHS”) announced a fourth amendment to its declaration under the Public Readiness and... 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
A compounding pharmacy based in Kentucky, and its owner, admitted on October 29, 2020 in federal court to unlawful distribution of compounded prescription drugs. The Pharmacy pleaded guilty to unlawful distribution of substances that the FDA had... Read More
With the imminent need for information on government action in regards to medical issues and potential lifesaving treatments during the Covid-19 pandemic, various state and federal agencies have seemingly dismissed the public’s right to... Read More
The rising cost of healthcare and the renewed focus on personal hygiene related to the COVID-19 pandemic has brought a marked increase in the use of over-the-counter (OTC) medications such as cold remedies, antihistamines, pain relievers and hand... Read More
