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Chief Executive Officer Jeremy Levin said in an interview.One of the FDAs most important functions is determining whether drugs work, he said. Insurer Oversight If there is any attempt to change the mission of the FDA — in other words, to prove both safety and efficacy — then Americas primacy in drug discoveries will suffer, Levin said. Any person who comes to run it needs to understand the value of clinical trials, the value of not just proving safety, but proving efficacy. Takeda Pharmaceutical Co. will continue developing drugs with the expectation that the FDA wont change its mission, said Ramona Sequeira, president of U.S. operations for the Japanese drugmaker. We spend a lot of time testing both the efficacy and safety of our drugs and have a full expectation to demonstrate both, she said in an interview. Limiting FDAs purview to drug safety is worth exploring, said Mark Baum, CEO of San Diego-based Imprimis Pharmaceuticals Inc., which makes compounded drugs.Insurers, the gatekeepers for much of patient care, already monitor drug efficacy, he said. There is some wisdom in thinking about whether we want the FDA in the efficacy business at all, he said in an interview. Appointing either Srinivasan or ONeill to head the agency would be a significant departure from tradition. For decades, trained physicians or prominent scientific researchers have overseen the FDA, widely considered the final word on safety of drugs for human health.
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