Statement on the Framework for FDA’s Real World Evidence Program

By Blair Childs, Senior Vice President of Public Affairs, Premier

Premier wholeheartedly applauds the FDA’s recognition of the importance of gathering real-world evidence (RWE) to gain insight into safety, efficacy, patient outcomes and cost-effectiveness of drugs and biologicals. As an alliance committed to delivering value to our members and their patients with one of the most comprehensive repositories of healthcare data, we see firsthand the value RWE can provide patients, providers and innovators. We also believe RWE can be used to transform the Drug Efficacy Study Implementation (DESI) pathway that, as currently designed, creates barriers to market entry leading to price gouging and shortages.

As one of the nation’s largest purveyors of RWE with data on approximately 45 percent of hospital discharges across the nation, Premier looks forward to working with the FDA to implement the Framework for FDA’s Real World Evidence Program.