PhRMA takes issue with elements of FDA draft guidance on labeling under the Accelerated Approval pathway

US trade group Pharmaceutical Research and Manufacturers of America (PhRMA), while broadly supportive of the Food and Drug Administration draft guidance on labelling for human prescription drug and biologics approved under the Accelerated Approval pathway, takes issue with certain aspects of the proposals.

PhRMA vice president of scientific and regulatory affairs, Sascha Haverfield, said: “PhRMA shares FDA’s goal of ensuring that information on the use of drugs and biological products approved under the Accelerated Approval pathway is consistently presented in the appropriate sections within prescription labeling so that the information is clear and accessible to health care providers.”

However, he continued: “The draft guidance’s proposal of limitations and caveats in the ‘Indications and Usage’ statement could be misinterpreted to mean that products approved under the Accelerated Approval pathway have not met the statutory requirements of safety and efficacy required of all FDA-approved drugs. This could result in confusion among healthcare providers and the public, undermining the intent of the Accelerated Approval pathway and recent Congressional efforts to encourage its broader use.”