FDA abandons proposal for devices referencing drugs
The US Food and Drug Administration (FDA) on Thursday said it will abandon a proposed regulatory approach for medical devices referencing drugs (DRDs) that would have allowed devices to be authorized for new uses with already approved drugs when the drugmaker does not want to collaborate on the new use.The decision comes after FDA held a public hearing to discuss the scientific, regulatory and legal challenges posed by the approach in November 2017. At the time, FDA envisioned that DRDs would primarily involve changes in how a drug is administered but allowed that the pathway could be used to support the use of an approved drug for a new indication. (RELATED: Devices referencing drugs: Questions raised over potential regulatory pathways, Regulatory Focus 16 November 2017).
“After further consideration and in light of the comments received, FDA does not intend to pursue the potential approach described in the referenced Federal Register document at this time,” FDA said, without citing any specific issues that led to the decision.
While the medical device industry largely supported the pathway, the proposal faced strong pushback from biopharmaceutical industry groups, with the Pharmaceutical Research and Manufacturers of America (PhRMA) calling it “unworkable and potentially damaging to the public health,” and the Biotechnology Innovation Organization (BIO) saying the entire proposal is flawed.
Federal Register Notice