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首页> 外文期刊>P & T: a peer-reviewed journal for formulary management >Drug Companies Worry About New 'Totality of Evidence' Standard: Is It an About-Face From the FDA on Off-Label Promotion?
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Drug Companies Worry About New 'Totality of Evidence' Standard: Is It an About-Face From the FDA on Off-Label Promotion?

机译：药物公司担心新的“证据总体”标准：它是从FDA脱离标签促销的关于 - 面对面吗？

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摘要

Incoming Food and Drug Adminis-tration (FDA) Commissioner Scott Gottlieb is a known proponent of allowing drug and device companies greater leeway to make the case for off-label use of their products. But Gottlieb faces a new controversy on that issue prompted by a final rule issued by the FDA in the waning days of the Obama administration. The Pharmaceutical Research and Manufacturers of America (PhRMA) and other groups are incensed with the FDA over one section in that final rule that not only seemed to come out of left field, but appears to reverse a position the agency took a few years earlier. The new position expands a company's liability for off-label promotion by deleting a sentence in a 1952 regulation that limited that liability. Moreover, the FDA replaced that 65-year-old sentence with a new one that drug manufacturers believe puts them more clearly in the agency's enforcement sights.
机译：入境食品和药物管理局（FDA）专员Scott Gottlieb是一个已知的支持者允许药品和设备公司更大的余地，以使案件造成其产品。 但Gottlieb面临着由FDA在奥巴马政府的失败日发出的最终规则提示的新争议。 美国的制药研究和制造商（Phrma）和其他团体在一个部分中与FDA孵化，在一个部分中，最终规则似乎似乎不仅从左领域出来，而且似乎扭转了原子能机构越来越几年的职位。 通过删除1952年规定的判决，该职位扩大了公司对非标签推广的责任，限制责任。 此外，FDA取代了65岁的句子与毒品制造商认为在原子能机构的执法景点中更清楚地将它们更加清晰地提出它们。

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