Industry Responds to Communication Guidances

In early 2017, FDA issued draft question and answer documents detailing how drug and device firms can discuss unapproved medical products with payers in ways that are "truthful and non-misleading," as well as in ways that are consistent with the FDA-required labeling. Industry offered many comments on the draft guidances outlining the FDA’s policies on industry communications with payers and claims that are on a drug’s label. We note a number of interesting comments from the Federal Register docket: Comments In BIO’s comments, the trade association points out: “While there are many sources of clinical and scientific information available to payors and HCPs, biopharmaceutical companies often possess the most detailed and up-to-date information about a given product, based on the company’s clinical trials to support approval and ongoing studies. Being able to proactively communicate truthful and non-misleading current information about their medical products would allow companies to ensure that: (1) payors have the comprehensive information needed to make well-informed and timely coverage and reimbursement decisions to ensure patients have access to the treatments their physicians prescribe; and (2) HCPs have the information they need to tailor treatment courses to the specific patient.” Merck points out: “Even with access to these new data, we expect that population health decision‐ makers will continue to be interested in the evidence pharmaceutical comp...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs