Top U.S. health officials laid out a road map on Tuesday to speed drug development and ensure the safety of diagnostic and gene tests based on personalized medicine — treatments tailored to a person's genetic makeup.
In a commentary released online by the New England Journal of Medicine, Dr. Margaret Hamburg, commissioner of the U.S. Food and Drug Administration, and Dr. Francis Collins, head of the National Institutes of Health, said their agencies will invest in efforts to provide companies with a clear regulatory path for both drugs and companion diagnostics.
"The success of personalized medicine depends on having accurate diagnostic tests that identify patients who can benefit from targeted therapies," Collins and Hamburg wrote.
To ease the transition from academic discoveries of new genes to potential new drugs, the NIH will develop centers where researchers can screen chemicals to find potential drug candidates, and foster public-private partnerships to move more drug candidates into commercial development.
The FDA is developing new scientific standards to establish what genetic information companies must show to prove their devices and drugs are effective.
The hope is to develop new drugs and diagnostics so doctors can prescribe "the right drug at the right dose at the right time," they wrote.
A report by PricewaterhouseCoopers last year found that 20 to 75 percent of patients respond to the drugs they are taking. But with companion diagnostics — tests used on patients before treatment to look for specific proteins or genes — that response rate could improve dramatically.
About 10 percent of drugs approved by the FDA already include information about "pharmacogenomics" — basically, how genes affect the drug's response.
PricewaterhouseCoopers projects that the market for molecular diagnostics, which includes such tests, could double to $5 billion in 2012 from $2.6 billion in 2007.
Collins and Hamburg want to nurture that growth, while providing a regulatory framework for genetic tests that "both protects patients and encourages innovation."
They said diagnostic tests often are not independently reviewed or validated by the FDA, and some lab tests that have not had FDA oversight have given wrong results.
To address this, NIH will create a voluntary genetic-testing registry on the more than 2,000 genetic tests on the market, offering ready information about whether the tests were cleared by the FDA.
That became an issue last month when Walgreen said it would begin offering personalized genetic test kits made by privately held Pathway Genomics in its neighborhood pharmacies.
The FDA stepped in, saying in a letter to the company it was "unable to identify" whether the tests had been approved by the agency, prompting Walgreen to put its plans on hold.
"Readily available information about these tests, including whether they were cleared or approved by the FDA, will help clinicians and consumers make informed decisions about using the test to optimize healthcare," Collins and Hamburg wrote.
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