Until recently, the pharmaceutical industry has been severely limited in its ability to communicate with customers regarding the economic impact of new drug treatments. Under the 21st Century Cures Act, which was approved with broad bipartisan support and signed by then-President Barack Obama in December 2016, the pharmaceutical industry has a much broader mandate to discuss healthcare economic information with payers and formulary decision makers—with some fairly reasonable requirements.
Under the same act, the FDA has much broader authority to consider real-world evidence and patient experience data when making market authorization decisions. As such, the FDA is better aligned with a strong trend in the global medical community, which offers a distinct place for this information next to the randomized, controlled clinical trials that the FDA has traditionally required.
On Jan. 18, the FDA provided draft guidance on the law’s implications, bringing more clarity to what the law means for pharmaceutical companies and their customers. Read more about what this may mean for you in an In Vivo article—"The 21st Century Cures Act: Allowing the FDA to Address Modern Value Communication Needs." I discuss how this step forward might affect various stakeholders across the pharmaceutical industry.
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