Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in FDA News, in “More FDA Guidance Needed to Untangle Combination Product Regulations.” (Read the full version – subscription required.)
Following is an excerpt:
The complex process of regulating combination products begins with the FDA’s determination of which center — CDRH, CBER or CDER — will take the lead role in overseeing a product’s development, but even after that determination is made, the way regulations are applied opens up another layer of complexity.
“At a high level,” says Bradley Thompson, an attorney at Epstein Becker Green, “the biggest problem the industry faces is that there simply aren’t enough FDA guidance documents that explain the rules with regard to combination products.” Because of how much more labor-intensive it is to have the centers work together, he said, “they do not often come up with guidance to help combination product developers,” leaving combination product developers “guessing.”
Current FDA guidance specific to combination products includes the September 2006 final guidance “Early Development Considerations for Innovative Combination Products” and the April 2011final guidance, “How to Write a Request for Designation (RFD).”
Additional guidance is most needed, Thompson says, in the areas of essential performance requirements, human factors validation studies, sequential preconditioning, post market product modifications and the impact of those changes on submission requirements, and “the applicability of FDA rules to digital drug-device combination products where software is used to guide or somehow facilitate appropriate use of a drug.”
Despite the abundance of therapeutic and diagnostic combination products, including such everyday products as transdermal products and antibiotic bandages, Thompson argues that they tend to “end up at the bottom of the priority list for the different centers.” This is because it takes much more additional effort to communicate between the centers, as opposed to within a given center, he explained.
