Drugs

Sharp Disagreement on DRD Pathway

Pharmaceutical Research and Manufacturers of America (PhRMA) says FDA should abandon its efforts to develop a devices referencing drugs (DRD) pathway, while the Advanced Medical Technology Association (AdvaMed) strongly endorses the proposal. In its comment letter. PhRMA says DRDs “pose numerous significant public health, safety, scientific, regulatory, and legal issues that make FDA’s proposal unworkable and potentially damaging to the public health. Utilizing the device premarket authorization pathway to regulate in the absence of collaboration from the drug sponsor is overly complex, burdensome, and may put patients and the public health at risk.”

PhRMA also asserts that FDA lacks the statutory authority to establish a DRD pathway in which significant new drug uses, such as new indications and patient populations, would be authorized outside of the drug or combination product pathways and without consent or cooperation from the drug sponsor.

For its part, AdvaMed says that while developing evidence to support DRDs is challenging, as is reviewing DRD submissions to assure that they meet regulatory requirements, providing patients with timely access to safe and effective devices is paramount, and the agency’s proposed approach serves that end. “Consequently,” it says, “AdvaMed generally endorses the proposal and offers … comments to support its position.”

FDA has raised a number of issues and questions, the association says, and AdvaMed has not developed in-depth positions on them. “But we believe that FDA can address them by applying commonsense principles, within the scope of its current regulatory authority, to create a market pathway for DRDs,” it concludes.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome