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By Malorye A. Branca

April 15, 2005 | Practically on his way out the door, FDA commissioner Mark McClellan announced the release of a new report detailing technological barriers to medical advancement. The FDA’s new “Critical Path” report calls for a unified front among academics, companies, patient groups, and the agency itself to accelerate the introduction of new medical products.

“In 2002, around the same time we were declaring victory in sequencing the human genome, the number of applications and product approvals at FDA was reaching a 20-year low for drugs, and new biologic applications and approvals were also down, as were new medical devices,” McClellan said during a press conference announcing the report.

The cause of this imbalance between technological advancement and medical application is that new science is not being properly applied to the product development process, according to the FDA report. McClellan pointed out key areas where technological deficits are slowing progress, including adoption of next-generation information technology, animal models, use of genomics and proteomics for safety and efficacy prediction, and manufacturing.

The agency now plans to push for collaborations to help solve these problems. Based on McClellan’s comments, the FDA’s role will be largely advisory. “Our researchers have a unique vantage point on the scientific challenges that can cause delays,” he said. The FDA has a limited basic research budget. McClellan said that cooperation with other groups, including the National Institutes of Health, will be essential to effect real changes.

The NIH’s 2004 budget is $28 billion, much of which will go to academic research projects. With the goal of squeezing more medical applications, more quickly, out of genomics, the National Human Genome Research Institute (NHGRI) in particular is focusing on some of the same trouble spots listed in the FDA report. “We have talked with them about our overlapping interests,” says Laura Lyman Rodriguez of NHGRI’s Policy and Program Analysis Branch. “And we are keeping in touch.” No specific collaborations are in the works yet, however.

The U.S. Senate recently confirmed McClellan as the new administrator of the Centers for Medicare and Medicaid Services. In the just over two years he has spent heading the FDA, McClellan has reinvigorated the formerly stagnating agency, launching multiple new initiatives and bringing renewed attention to topics such as pharmacogenomics.


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