Statement on FDA’s Commitment to Prioritizing Drug Approvals and Use of Data

The Premier healthcare alliance applauds the FDA’s new approach to prioritizing the review of generic drug applications to target products that lack competition, are in shortage, or are urgently needed to protect the public’s health. As outlined, the policy also has the potential to prevent patent or exclusivity issues from blocking entrants of lower cost generic alternatives in the drug marketplace.

We are also encouraged that right out of the starting gate, FDA Commissioner Stephen Hahn has committed to bolstering his agency’s use of data and health IT infrastructure. Informing decisions on drug and biologic approvals and evaluation of treatments with real-world data will offer insight into safety, efficacy, patient outcomes and cost-effectiveness of drugs and biologicals. With data on roughly 45 percent of hospital discharges across the nation, Premier applies real-world evidence daily to help health systems drive total cost and quality improvements in healthcare.

We stand ready to work with the FDA in these efforts, and to help find additional ways to ensure that the agency’s actions have the greatest impact on access to critical treatments, lowering costs and protecting public health.