In one of the biggest drug pricing settlements in history, Pfizer is paying $784.6 million to settle claims alleging that the practices of its Wyeth subsidiary relating to the calculation of Medicaid rebates for Protonix (pantoprazole sodium) violated the Federal Civil False Claims Act and other laws.
Health Law & Policy
In FDA’s latest approval of a new medication to treat multiple myeloma, the agency approved Ninlaro capsules, the first and only oral proteasome inhibitor, indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy
The US Supreme Court today stated that pay-for-delay agreements between brand name drug companies and generic manufacturers are subject to antitrust scrutiny.
A New York federal judge has struck down the restrictions on levonorgestrel-based emergency contraceptives and ordered the FDA to make the drugs available without a prescription and without point-of-sale or age restrictions within 30 days, according to an April 4th memorandum and order
The shift of Medicaid patients from fee-for-service to Managed Medicaid during 2011 resulted in a massive shift of prescriptions nationally, with nearly half of all Medicaid prescriptions now filled by Managed Medicaid, according to a recent study released by the IMS Institute for Healthcare Informatics. It was presented April 4 during the Academy of Managed Care Pharmacy Annual Meeting in San Diego.
The number of monthly prescriptions dispensed through Managed Medicaid increased from 4.9 million in September 2011 to 12.5 million in June 2012, as reported in the IMS Institute study, “Impact on Patient Care of Shift From Fee-For-Service to Managed Medicaid.”
The Academy of Managed Care Pharmacy (AMCP) recommends that the Centers for Medicare & Medicaid Services (CMS) evaluate existing national quality health measures before implementing quality metrics in state health insurance Exchanges starting in 2016.
The passage of the FDA Safety and Innovation Act will support innovation, answer the current shortages, and even regulate mobile applications.
While scientists and biomedical researchers at the recent meeting of the American Society of Clinical Oncology (ASCO) applauded encouraging data on dozens of breakthrough cancer therapies, analysts pondered strategies for convincing payers to cover the new life-saving drugs.
The drive for personalized medicine and greater patient involvement in treatment decisions demands more informative data on the effects and risks associated with drugs and medical products.
After months of anticipation, FDA issued guidances last month that outlines its recommendations for developing and approving biosimilar therapies.