Sen. Lamar Alexander (R-Tenn.) requested on Thursday that Health and Human Services Secretary Kathleen Sebelius provide clarification on the Obama administration’s position on patient access to personal health information.
Last year, the FDA notified 23andMe, a company that makes generic medical tests, that action would be taken to stop the company from marketing tests directly to consumers because individuals could not be trusted with test results.
Sebelius recently said, however, that lab results and other information could empower patients to track their health progress, make better decisions about their healthcare and adhere to treatment plans.
“Some centers within (HHS) seem to be in agreement with the goal to make personal health information available directly to consumers, as shown by the final rule allowing clinical laboratories to give complete test reports directly to patients, published by the Office of Civil Rights, Center for Medicare and Medicaid Services, and Center for Disease Control and Prevention,” Alexander said. “…However, (Sebelius’) statement and the final regulation appear to be in direct conflict with the Food and Drug Administration’s warning letter from Nov. 22, 2013, to 23andMe, Inc., a direct-to-consumer genetic testing laboratory. FDA stated one reason it was taking action to stop 23andMe is that FDA does not trust individuals with test results, because results are not adequately understood by patients.”
Alexander, the ranking member of the Senate Health, Education, Labor and Pensions Committee, said targeted drug therapies depend on the availability of a range of diagnostic products and consumers should have the right to personal information to make informed decisions.
Alexander requested clarification of HHS’s position and information on the criteria used to evaluate the different types of tests.