FDA Panel Suggests Physician Oversight of DTC Genetic Tests

Emma Hitt, PhD

March 09, 2011

March 9, 2011 — A US Food and Drug Administration advisory committee has agreed that direct-to-consumer (DTC) clinical genetic tests should have more oversight from the US Food and Drug Administration (FDA).

In a meeting yesterday and today in Washington, DC, the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee sought to discuss several issues, including the risks of incorrect or misunderstood results for DTC testing performed without counseling and the level of evidence needed for manufacturer claims about DTC genetic tests. No formal votes were taken, however.

"The DTC model for offering tests has created public health and social quandaries," the FDA notes in an executive summary included in the meeting materials. “Tests that predict drug response, tests that predict serious future health risks, and tests that provide preliminary findings of genotype-phenotype associations are now available to persons ordering their own testing."

According to the FDA, DTC clinical genetic tests are similar in several ways to home use medical tests. "Yet unlike home use medical tests, many DTC clinical genetic tests often carry a disclaimer stating that they are intended for 'educational and informational' purposes, and that the individual receiving the test results may wish to take them to their clinician for follow-up."

"We can’t protect everyone, but it is the job of the FDA…to weigh the risks and benefits, and make sure that the benefits are going to outweigh the risks if a product is used as directed," Mary Pendergast, JD, an independent consultant and former associate chief counsel for enforcement at the FDA, said during the meeting.

According to Pendergast, there is no simple answer. "It’s fine that people want to make money selling their products…but we still need standards that protect patients…and to do the best we can to make the information understandable," she said.

Organizations in Favor of Closer Scrutiny of DTC Tests

The American Medical Association (AMA) has stated that they are in favor of including the guidance of a physician for making decisions based on DTC tests. "Without the benefit of proper medical counseling, patients may spend money on direct-to-consumer genetic tests needlessly or misinterpret the results of the tests, causing them to make unnecessary or unhealthy lifestyle changes," noted AMA Chair Ardis D. Hoven, MD, in a news release.

"While genetic testing can be a valuable tool to aid in diagnostic and therapeutic decisions, it should be done under the guidance of a physician, genetic counselor, or other genetics specialist," Dr. Hoven said. "These health professionals are best prepared to help patients understand the results and the limitations of the tests, and what type of action should occur based on the results."

The American Society of Human Genetics (ASHG) notes that their organization, as well as several others, has called for closer scrutiny of genetic testing. The US Centers for Disease Control and Prevention has issued guidelines for laboratories, and the National Institutes of Health is developing a genetic test registry.

"Given the current lack of independent oversight and federal regulation of clinical and DTC genetic tests, it is important that both healthcare providers and consumers evaluate each test in light of its specific use, its reliability and accuracy, and whether or not the test results will provide useful information," the ASHG notes in a news release.

Manufacturers Want Clearer Guidelines

Several manufacturers of DTC tests presented their perspective at the meeting, addressing some of the concerns of the FDA. "One of the assumptions has been that patients leave their physicians with a perfect understanding of their test results and the limitations of their test results," said Ed MacBean, vice president of product management with Pathway Genomics, which manufactures several DTC genetic tests. "I feel confident in saying that many patients leave their physicians feeling uncertain and confused about their results," he said.

DTC tests manufactured by Pathway Genomics came onto the radar of the FDA in April 2010 when the company announced a pact with Walgreen Co. to distribute tests in 6000 neighborhood pharmacies.

"The FDA could provide automated guidance on the appropriate regulatory pathway and specific guidelines," said MacBean. This would have avoided the "uncertain regulatory situation that we are still discussing today." He and other manufacturers also supported the use of a registry, which would enable vendors, consumers, and the FDA to be more informed.

"Hopefully, the specter of FDA oversight will move the for-profit companies to strive upward along a continuum of higher standards," said panelist and consumer representative Margaret Davis, JD, PhD.

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