Washington D.C. Partner Kevin Madagan of Reed Smith’s Life Science Health Industry group will participate in an exert legal panel discussion at the 2017 Health Care Distribution Alliance (HDA) Traceability Seminar held November 8-10 in Washington D.C. Implementation of the Drug Supply Chain Security Act (DSCSA) continues to transform the pharmaceutical supply chain. As the … Continue Reading
The Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Industry Organization (BIO), and the Generic Pharmaceutical Association (GPhA) have jointly filed a Petition for a Writ of Certiorari with the U.S. Supreme Court, asking for review of the Ninth Circuit's decision in PhRMA v. County of Alameda, in which the court ruled that Alameda County's Safe Drug Disposal Ordinance - requiring pharmaceutical manufacturers to establish or participate in a program for collecting unwanted prescription drugs from consumers - was constitutional.… Continue Reading
Over at the Drug and Device Law Blog, there are several posts analyzing the meaning of the Second Circuit’s opinion in United States v. Caronia, 703 F.3d 149, 160 (2d Cir. 2012), including this one and this one. Most Caronia commentary has focused on the court’s First Amendment holding, that the FDCA does not ban … Continue Reading
On Friday, January 27, 2012, the Centers for Medicare & Medicaid Services ("CMS") released its long-awaited proposed rule to implement the provisions of the Affordable Care Act ("ACA") relating to pharmaceutical manufacturer payment of Medicaid rebates and limits on Medicaid reimbursement to pharmacies. The proposed rule addresses a number of important policy issues relevant to pharmaceutical manufacturers, pharmacies, and other providers, and also would pose significant operational challenges for pharmaceutical manufacturers with respect to the Medicaid Drug Rebate Program ("MDRP").… Continue Reading
