AMA calls for regulation of consumer genetic tests

Washington -- The American Medical Association is calling on the Food and Drug Administration to regulate genetic tests that are sold directly to consumers, saying the tests need to be conducted under the guidance of a physician or another expert.

In a Feb. 23 letter to the agency's molecular and clinical genetics panel, the AMA says patients can be hurt if they buy genetic testing kits and use them without proper counseling from a medical professional. Such tests can be unnecessary and easy to misinterpret, potentially leading the patients to make unhealthy choices in their lives, said Ardis Dee Hoven, MD, chair of the AMA Board of Trustees, in a statement.

"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."

In the letter to the FDA, AMA Executive Vice President and CEO Michael D. Maves, MD, wrote that physicians are most concerned about tests that could prompt patients to pursue unnecessary medical treatments. In some cases, the vendors of the tests effectively are practicing unauthorized medicine, he said. The Association wants the federal government to regulate the screenings much as it does medical devices.

The AMA also supports a plan by the FDA and other agencies to create a genetic testing registry, and the Association wants the registry to include information about the clinical authenticity of direct-to-consumer genetic tests that are available to patients. As more physicians have patients who have encountered one or more of these tests, doctors need the correct information to be able to tell them whether the screenings are accurate and appropriate. Participation in the registry should be mandatory for test vendors, Dr. Maves wrote.

An undercover investigation last year by the Government Accountability Office found that results of consumer genetic tests are unreliable, and marketers of such tests sometimes overstate their value to sell other products and services. The GAO report prompted the FDA to step up its scrutiny of the tests' vendors and increased calls for more federal regulation of the industry.

The AMA letter to the FDA is available online (link).