Rosen Comments on Proposed Changes in FDA Drug-Device Rules

Partner David Rosen is quoted in a Bloomberg Law article, “Drug-Device Rules Could Give FDA Leg Up in Industry Fights,” about the FDA’s plan to revamp its rules on how to deal with overlapping drug, device and biologic products.

Rosen said it makes a big difference how a product is classified and which FDA office reviews it. “People would love products, for example, to be medical devices when they possibly can because it’s a lot less expensive and the time frame is generally a lot shorter,” he said.

He also said one proposed change – which would clarify that only product sponsors (such as drug companies or device makers) can submit a request for designation to suggest how a product should be classified and which office should be assigned to review it – is likely to be challenged because sponsors don’t always want to be identified early in the development process. “They want to keep things confidential so they engage us lawyers to write these requests without definitely identifying who they are,” he said.

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