Teva reaches $27.6 million settlement with Department of Justice and the state of Illinois over prescriptions for generic clozapine; deal comes as Ivax subsidiary is in final year of five-year corporate integrity agreement.
Teva Pharmaceuticals USA Inc.’s $27.6 million settlement with the Department of Justice and state of Illinois to resolve kickback allegations ranks as one of the smallest in the pharmaceutical sector. But the fact it involves alleged payments to just one doctor shows how tenacious the government can be in pursuing drug makers for healthcare fraud.
In a March 11 release announcing the settlement, the DOJ said it resolves allegations that Teva and its Ivax...
Clarity on payer responses to controversial vaccine recommendations from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices may be coming.
The FDA wants to ensure participants in clinical trials involving genetic engineering done in China understand what the agency sees as privacy and security risks. The agency also wants cell therapy processing done outside of “hostile” countries.
Davis, a former FDA team leader in the Division of Psychiatry Products, rejoins the agency from the Usona Institute, which develops psychedelics. His background aligns with Commissioner Martin Makary’s goal of seeing new treatments approved for post-traumatic stress disorder.
The Trump Administration’s rhetoric and policy approaches illustrate the confusion that often arises between efforts to cut drug prices and cutting spending.
Companies with significant exposure to Medicare and Medicaid have fewer options for passing along higher costs to consumers because of price controls in the programs.
The news coincides with rumors that Commissioner Martin Makary soon will name a new Center for Drug Evaluation and Research director.
US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.
