Recently, the US FDA (Food and Drug Administration) publishedtwo guidances它的目的是阐明其通信（医疗产品通信）的策略，将医疗产品数据与付款人介绍，并以FDA要求的标签以可靠方式传达有关产品的数据的最佳方式。
该指南显示了FDA如何在法院不幸和定居点的进展之后，如何更新其监管医疗产品的方法，包括标签外的进步，以及是否通过第一修正案确保了此类通信。两项最终指南都包括与2017年1月发布的版本草案的更改，以响应行业言论，并试图解释该组织的沟通政策medical deviceinformation that doesn’t fall inside approved labelling in an honest and non-misleading way.
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FDA’s final guidance on payor interchanges includes four new questionnaires and solution from the draft guidance intended to expand on the agency’s policies toward communicating information about unapproved products or uses of approved products to payors, formulary committees, and other similar entities.
FDA Commissioner Scott Gottlieb said the guidance will help address prescription drug spending by reducing obstacles to manufacturers communicating information about their products’ value to payors, formulary committees and other entities involved in price negotiation and coverage decisions.
Gottlieb说：“付款人寻找有关批准 /清除药品的有效性，安全性和成本效益的数据范围，包括来自药品制造商的数据，以帮助支持产品选择，配方管理或潜在的范围和还款选择。”
他说，这种数据通常不涵盖办公室用来做出有关产品的监管决策的数据。
Gottlieb additionally drew a distinction amongst payors and the general public in their capacity to interpret and assess data about drugs and devices that aren’t really included in the product’s label.
“The payors who get this data … are complex parties who approach a lot of expertise in evaluating this data,” he said.
在与草稿版本的更改中，最后的付款人通讯指南现在讨论了药物和设备制造商如何在其产品的总生命周期内传达“真实，不明显和适当的信息”。该指南同样展示了制造商如何以真实的，非误解的方式检查有关未经认可的产品或未经批准产品的数据的数据。
根据Gottlieb的说法，这可以通过授权付款人来调查未经批准物品的相关数据来帮助对新药品的覆盖范围决策。
“与FDA频繁的标签一致”指南
FDA likewise finalized its questionnaires and guidance direction on product communications that are consistent with the FDA-required labelling, detailing the agency’s current thinking on the subject through a set of 11 questions and answers.
“标签是content necessities and limitations to guarantee that it adequately communicates information. It’s not expected to comprehensively address all that is thought about a product for its approved or cleared uses,” Gottlieb stated that taking note of that relevant data about a product from postmarket studies and surveillance may not be available in a product’s approved labelling.
Especially, FDA clears up in the final guidance that it doesn’t mean to depend on such communications as the reason for setting up another proposed use for a product not the same as its legally marketed use(s), so long as the communication is consistent with required labelling.
这应该减轻行业的关注，即该机构可以利用此类通信来发现公司正在营销一种未经批准的预期用途的产品。
该指南还提供了许多通信示例，该机构将考虑使用产品的标签可靠，并将其视为与标签冲突。