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“Test Case” Arbitrations an Effective Alternative to Class Action Arbitrations for Independent Pharmacies Challenging PBM Audits

Class action arbitrations were one of the most powerful tools in a lawyer's arsenal to help independent pharmacies force nation-wide changes to abusive PBM auditing conduct. A class action arbitration is a procedural device that permits one or more independent pharmacies to file and prosecute a claim on behalf of a larger group of independent pharmacies. Without class action arbitrations, independent pharmacies looking to challenge abusive PBM practices are forced...

Specialty Pharmacies Continue to Face Legal and Ethical Issues Employing Hemophilia Patients to Market Drug Products

Approximately 20,000 Americans suffer from hemophilia, a genetic disease which inhibits a patient's blood clotting ability. Hemophilia is caused by genetic mutations in a patient, and is hereditary, meaning that the condition is often passed down from generation to generation. Hemophilia is treatable through a variety of specialty drug products which frequently cost over $100,000 a year, per patient, and can cost over $1 Million a year for some. The...

FDA Under Scrutiny from the U.S. Senate Over Guidance Documents on Biosimilars

The Food and Drug Administration (FDA) is currently under scrutiny from the United States Senate due to the FDA’s inability to release certain guidance documents on biosimilars in a timely fashion. Speaking in front of the Senate Subcommitee on Primary Health and Retirement Security on September 17, 2015, Janet Woodcock, the director of the Center for Drug Evaluation and Research, explained that the delay in releasing the much anticipated guidance...