Either Senator Lamar Alexander (R-Tenn) reads the FDA Law Blog, or great minds truly think alike. On February 20, 2014, Senator Alexander wrote to Secretary of Health and Human Services (HHS) Kathleen Sebelius asking her to clarify HHS’s position regarding patient access to health information, noting the same discrepancy between FDA’s warning letter to 23andMe and the recent rule change that would require laboratories regulated under CLIA to provide test results directly to patients upon a patient’s request that we identified two weeks ago.
Senator Alexander, with whom we share a love of plaid, noted in his letter that “[s]ome centers within your department 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. . . . However, your statement and the final regulation appear to be in direct conflict with the Food and Drug Administration’s warning letter from November 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.”
Senator Alexander asked Secretary Sebelius “What is your Department’s position on greater direct access to personal health information for patients? Further, please describe what criteria were used to evaluate the types of tests described in these two actions that resulted in such opposite outcomes.” We expect that his letter may garner a more immediate response than our blogpost, but we remain hopeful that Secretary Sebelius may yet comment on our blogpost, or at least accept our friend request on Facebook.