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FDA Releases Report Describing Critical Path ; Cites Proteomics as One Enabling Technology

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In a report released this week, the FDA announced plans to focus more resources and effort on what it called the “critical path” that takes a drug, biologic, or medical device from benchtop to bedside — and it identified proteomics as one of the key technologies that could make this path a faster and more efficient one.

The report, entitled Innovation or Stagnation? Challenge and Opportunity on the Critical Path to New Medical Products (click here for report), acknowledged the oft-cited slowdown in recent years in the FDA approval of new products, and placed blame on an underdevelopment of “medical product development” strategies. Outgoing FDA Commissioner Mark McClellan said during a teleconference discussing the report that product approvals at the FDA had reached a 20-year low both for drugs and for medical devices, and that rates for products in phase III clinical trials to even reach the application phase for FDA approval were only one in two These failure rates drive up the cost of drugs, he said. As a result, “today the cost and uncertainty of bringing medical treatment to patients is greater than ever.”

The report cited toxicoproteomics and proteomic biomarkers as two emerging applications with potential use in bridging the gap between basic science and therapy development, and actual FDA approval. But it noted that these applications were in need of further development.

“The emerging techniques of pharmacogenomics and proteomics show great promise for contributing biomarkers to target responders, monitor clinical response, and serve as biomarkers of drug effectiveness,” the report said in regards to the latter application. “However, much development work and standardization of the biological, statistical, and bioinformatics methods must occur before these techniques can be easily and widely used.”

The report also cited proteomics as one of the new technologies being developed in basic science but not making its way to the bedside. It reiterated that the FDA would continue to put out guidance documents to help along this process (see PM 2-13-04, 2-20-04), noting that “medical devices developed in areas with extant FDA guidance documents are almost twice as likely to be approved after the initial review process and are approved in a third less time.”

The FDA has not yet issued a guidance specifically for the regulatory approval of proteomics-based medical devices, although the FDA released a guidance last year for more general multiplexed devices. In part due to a lack of guidance, those hoping to get a proteomics test approved have met with plenty of uncertainty (see PM 2-27-04). David Feigel, director of the Center for Devices and Radiological Health, said that it was the FDA’s responsibility to define regulatory pathways for products for which a precedent product did not already set the tone. “We think we have an important role in defining that so that we can break open that pathway and allow the products to move forward,” Feigel said.

McClellan said that the FDA will also seek to undertake more partnerships in which the agency can work closely with academic, government, and commercial groups to “turn the process of bringing [products] to patients from a costly and time-consuming art form to a well-understood science.” Jesse Goodman, director of the Center for Biologics Evaluation and Research, cited CBER’s biomarker discovery collaboration with the NCI as an example of such a partnership.

McClellan deflected questions as to whether the FDA would have an increased budget for undertaking such partnerships, emphasizing several times that the FDA “only has limited applied research funds available.” Rather than moving funding from one area to another, “we are planning on looking closely at our own other applied research activities to make sure they’re targeted as effectively as possible on these critical path barriers,” McClellan said. He said that in addition to a limited pool of funding from the FDA, he expected collaborative partners to foot part of the bill for such partnerships. What the FDA had to offer to these efforts was not so much money as “our unique vantage point on everything going on in product development,” he said. “[W]e have expert scientists on staff, many of whom have long been involved in trying to identify ways to overcome problems and to make the process of developing new treatments more predictable and faster,” he said.

The FDA will host a series of workshops and meetings as a next step in the critical path process, and Lester Crawford, deputy commissioner of the FDA, said in a press release that the agency’s upcoming April Science Board meeting “will be devoted to this topic.”

— KAM

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