The U.S. Food and Drug Administration recently withdrew its plans for a “Devices Referencing Drugs” (DRD) regulatory approval pathway, which it had proposed in September 2017. The DRD pathway could have helped ensure Americans’ access to innovative uses of established drugs, but now with the withdrawal of this proposal, it is unclear whether FDA will again consider any solutions to the so-called “cross-labeling” problem. As a result, DRD sponsors remain in a “regulatory box,” with limited options.
On September 26, 2017, FDA had issued a notice in the Federal Register seeking comments on its proposal for a new regulatory category, known as DRDs; we summarized that proposal online here. Under this proposal, DRDs could be approved as devices that (1) propose a new use for an approved, marketed drug, where (2) the new use is not included in the drug’s labeling, and the drug sponsor is not likely to seek to change the labeling. The DRD approval pathway would have helped to resolve a perennial and unworkable regulatory problem that occurs when a device sponsor proposes to label its device for use with a drug in a manner that goes beyond the existing drug labeling, but where the drug sponsor is unable or unwilling to effect the labeling change, and the device sponsor lacks capacity to become a drug sponsor itself and take the FDA-required step of submitting an NDA. The proposed DRD approval pathway would have offered significant regulatory flexibility for combination product sponsors who face this so-called “cross-labeling” problem, and thereby offered a promising and much needed solution for devices that seek to use older, mainly generic drugs in innovative ways.
Under the current system, where a device sponsor proposes to label its device for use with a drug in a manner that may go beyond the existing drug labeling, FDA typically requires the submission of a new drug application (NDA). This puts the device sponsor in a regulatory box: (1) collaborate with the drug sponsor to seek the labeling change, (2) become a drug sponsor itself and file the NDA directly; (3) seek more general device labeling; or (4) abandon the program (at least in the U.S.). All too often, we have seen device innovators choose the third and fourth options, leaving patients in the U.S. without access to potentially novel uses of well-established drugs.
Despite the possible benefits of the DRD approval pathway, last month, FDA announced a follow-up to the September 2017 Federal Register notice that simply stated: “[A]fter further consideration and in light of the comments received during the public hearing and submitted to the docket, FDA does not intend to pursue the potential approach described in the document at this time,” signifying that the agency was withdrawing its plans for the DRD regulatory category. The follow-up did not cite any specific issues that led to the decision.
While there was large support for the DRD pathway from the medical device industry, comment letters from biopharmaceutical industry groups questioned the proposal, which may have led to FDA’s decision. However, FDA’s withdrawal of this option has left no clear pathway forward for DRD sponsors, and the absence of information in the notice has left questions as to whether FDA may again consider this option in the future.
We will continue to monitor and keep you apprised of developments related to approval pathways for combination products. Please feel free to contact any of the authors of this alert for further information or assistance.