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PMC Urges FDA to Clarify Rules for Drug-Diagnostic Combinations

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In an effort to encourage innovation in drug development, the Personalized Medicine Coalition has written to the Food and Drug Administration (FDA) urging the agency to clarify its requirements for approving drug-diagnostic combinations.

At issue are combinations of targeted drugs and molecular diagnostics, the hallmark of personalized medicine. Companion diagnostics can target therapy more precisely by identifying potential responders or non-responders to a specific drug, and by more precisely identifying individuals at risk for adverse events.

Although companion diagnostics could substantially improve the accuracy of medical care, they've been slow to take off, in part because FDA has failed to follow up on a ''concept'' paper it published in 2005 on how the drug/diagnostic combinations might be regulated. Drug and diagnostic makers have been left in limbo on how the government will treat new products, even as the science to develop more innovative diagnostic tests and targeted drug therapies has sped forward.

''People have been clamoring for guidance from FDA on this issue,'' said Robert E. Yocher, Vice President for Regulatory Affairs at Genzyme Corporation, who led the PMC working group that drafted the regulations. ''We felt it was important to help speed the process by our ability to reconcile differing views.''

A total of 40 PMC members primarily from the laboratory, drug and diagnostics sectors served on the working group that developed PMC's comment letter, which Sheila Walcoff and Paul Radensky, M.D. of McDermott Will & Emery LLP revised and finalized for submission to FDA.

''By bringing together the three communities most impacted by FDA action on the regulation of companion diagnostics-diagnostic kit manufacturers, pharmaceutical companies and laboratories to create a consensus document, PMC provided the agency with unique insight,'' said Amy Miller, PMC s public policy director.

Unless FDA can establish clear, consistent regulations for co-developed and companion drugs and diagnostics, personalized medicine will not develop as fast as it might, the coalition wrote in its 14-page comment letter.

''Although genomic science and technology continue to advance rapidly, the ability of innovative companies to co-develop, validate and commercialize drugs and diagnostics cannot realize its full potential for the benefit of patients without greater regulatory clarity, in particular with respect to the standards of evidence necessary to validate co-developed and independently developed diagnostics to support a specific reference to or requirement for such testing in therapeutic labeling as well as the process developers should take to develop such evidence,'' PMC wrote.

Without explicit rules, physicians and patients lack a clear understanding of which diagnostics FDA has approved, PMC said, and companies must navigate multiple centers and divisions at the agency to obtain approval for their products.

FDA Commissioner Margaret Hamburg has said that FDA’s current ''regulatory schemas'' are ill-suited for genetic and genomic testing and the broader field of personalized medicine. She has said that the FDA is ''on the cusp of a whole new way of doing business'' with respect to when and how it will regulate the building blocks of personalized medicine such as genetic tests and targeted drug therapies.