Johnson & Johnson (J&J), Allergan, Pfizer and industry group BIO’s suggestions to the US Food and Drug Administration’s (FDA) new Combination Product Policy Council released Monday build on efforts included in the 21st Century Cures Act and the new user fee agreements.
J&J calls on FDA’s new council to address the process and principles for determining the primary mode of action with cross-center collaboration to ensure technical considerations are included in the decision, and not "solely because the combination product has any chemical action within or on the human body." In August, FDA launched a pilot project to begin such intercenter consult requests on combination products.
J&J also requests that the council consider "a mechanism to review product-specific (i.e., application related) inter-center disagreements during a product’s review cycle that cannot be resolved by the Office of Combination Products," noting that such a resolution prior to a final decision would eliminate the need for an appeal and save resources for FDA and the sponsor.
Allergan, meanwhile, seeks consideration for some combination products that in the past have not typically been treated as such, including transdermal patches, eyedropper bottles, adhesive tapes, pumps without metered dose features and elastomeric rings.
"We would appreciate the Combination Product Policy Council discussing these systems and providing clear guidance as to whether they are or are not drug delivery devices and whether they should be treated as a medical device constituent parts of drug/device combination products," Allergan’s director of global regulatory affairs John Smith writes.
Allergan also seeks more clarity on submission requirements for post-approval changes, particularly for combo products approved under new drug applications, and when post-approval changes to a delivery device must be submitted to the agency for review prior to implementation.
"Many drug delivery devices (for example, prefilled syringes) would be in class II if they were stand-alone medical devices and some drug delivery devices would be in class I. For these lower-risk products, when regulated as stand-alone medical devices, post-approval changes may often be made without a submission to FDA," Allergan adds.
Pfizer calls for the FDA council to oversee parts of the 21st Century Cures Act that call on FDA to issue guidance on pre-submission interactions for combination products and to identify good manufacturing practices, in addition to other provisions from the sixth iteration of the Prescription Drug User Fee Act, up for reauthorization this summer.
In addition, BIO calls on the council to align internationally recognized standards with pharmacopeia or guidance and to "consider the issue of how misaligned communication pathways for drug-led and device-led reviews limit the ability to interact directly with reviewers."
The group also says the council should consider pediatric development of combination products, noting the agency should "consider developing guidance that addresses how to manage these differences [between the drug and device divisions] for submission and post-market activities for pediatric drug-PMOA [primary mode of action] combination products."