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
State legislative initiatives to regulate Pharmacy Benefit Managers (“PBMs”) have gained momentum. Arkansas successfully defended its state PBM regulation in 2020 before the United States Supreme Court. Now, more states have been enacting... Read More
During the past year, the COVID-19 pandemic has illuminated, more than ever before, the critical role government agencies have in virtually all aspects of our lives, including public health. The Freedom of Information Act (“FOIA”), 5 U.S.C. §... Read More
Inventory maintenance, a routine undertaking in most businesses, is among the most crucial tasks performed by pharmacists and may have profound repercussions if not handled accurately. In particular, inventory shortages are common discrepancies... 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
In a prior article, we addressed mandatory exclusions from federally funded health care programs for certain criminal convictions, and the importance of "thinking globally" while resolving a criminal investigation. Put another way, collateral... 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
Frier Levitt Partner, Anthony J. Mahajan, Esq. has authored an article in the May 13, 2021 issue of the New Jersey Law Journal titled DEA's Proposed 'Two Option' Format for Suspicious Order Reporting Is the Wrong Option. In the article he... 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
On May 4, 2021, the Department of Justice announced that Incyte Corporation has agreed to pay $12.6 million to resolve allegations that it violated the False Claims Act by paying kickbacks through a non-profit organization. The Department alleged... Read More
