On July 9, 2021, President Biden issued an executive order (EO) containing 72 directives to more than a dozen federal agencies, many of which have broad implications for healthcare. Specifically targeted are healthcare competition, hospital mergers,... Read More
PBMs have historically accepted pharmaceutical manufacturer coupons so long as the usage of such coupons complies with both state and federal law. Recently, however, PBMs have begun to allege technical breaches of the contract for a pharmacy’s... Read More
Increasing complexities in the pharmaceutical supply chain have led to challenges in the purchase and distribution of pharmaceutical products directly to medical practices. While the traditional role of MSOs is centralization of administrative and... Read More
The Food and Drug Administration (FDA) continues to recommend additions to the 503(B) Bulks List (https://www.fda.gov/media/94164/download). A component of the Drug Quality and Security Act of 2013, the list includes drug products that 503(B)... Read More
The Department of Justice (“DOJ”) has recently announced that it is ramping up its efforts to prosecute fraud in clinical research trials. To obtain Food and Drug Administration (“FDA”) approval for new drugs and medical devices, it must be... Read More
As a follow-up to our previous article on the CREATES ACT, other types of clinical trials for which we seek comparator drugs are mostly for head-to-head comparisons for new indications, or non-inferiority trials, and generally fall under 505(b)(1),... Read More
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
