FDA, CMS leaders: Shared data from EHRs, registries will speed quality innovation


To ensure speed and quality in regulatory and coverage decisions reached by the U.S. Food and Drug Administration and the Centers for Medicare & Medicaid Services, relevant and collaborative data is a must, according to leaders from the agencies.

In a viewpoint published Monday in the Journal of the American Medical Association, CMS Acting Administrator Andy Slavitt, FDA Commissioner Robert Califf and FDA Deputy Commissioner for Medical Products and Tobacco Rachel Sherman argue for rapid evaluation of promising innovations. However, they note that such evaluation must focus on genuine user cases as opposed to “narrow, strictly delineated populations.”

Electronic health records, insurance claims and data within clinical registries, they say, have the potential to “significantly improve the quality and reduce the cost of evidence generation,” while also enabling greater diversity of results that can be examined.

“This, in turn, will provide the evidence needed to better characterize the balance of risk and benefit and establish the appropriate use and value of therapies in clinical practice,” Slavitt, Califf and Sherman say.

The leaders add that as use of such tools becomes more ubiquitous, the industry will reach a “tipping point” in which more inclusive trials can be conducted more broadly and at less cost. “This will allow the FDA and CMS to measure health outcomes that matter to patients and healthcare consumers and define the appropriate use of medical products in a more straightforward, evidence-based manner,” they say.

The 21st Century Cures Act, a bill that aims to accelerate the discovery, development and delivery cycle to get promising new treatments and cures to patients more quickly, is expected to be discussed in the upcoming lame-duck session of Congress following the general election. The House passed the bill in July 2015, but lawmakers continue to try to hammer out a Senate version.