Sen. Lamar Alexander (R-Tenn.) is asking Health and Human Services Secretary Kathleen Sebelius to explain what he says are conflicting federal policies about giving patients access to their personal lab data. Alexander said in a Feb. 20 letter to Sebelius that a warning letter to the genetic test maker 23andMe Inc. conflicted with a recent final rule from the federal agency giving patients the right to access their medical test results directly, rather than rely on their doctors to pass on the information. The Food and Drug Administration (FDA) told 23andMe in November 2013 to immediately stop marketing its Saliva Collection Kit and Personal Genome Service to consumers until it received federal marketing approval for the product. At the time, the FDA said, “serious concerns are raised if test results are not adequately understood by patients or if incorrect test results are reported.” But Alexander said that patients were given the right under a final rule (79 Fed. Reg. 7,289) published Feb. 6 to directly access their laboratory test results. The FDA warning letter, he concluded, conflicted with the HHS’s new policy to give patients access to their lab results without physician interpretation of the results. “These are two conflicting […]
Sen. Lamar Alexander (R-Tenn.) is asking Health and Human Services Secretary Kathleen Sebelius to explain what he says are conflicting federal policies about giving patients access to their personal lab data.
Alexander said in a Feb. 20 letter to Sebelius that a warning letter to the genetic test maker 23andMe Inc. conflicted with a recent final rule from the federal agency giving patients the right to access their medical test results directly, rather than rely on their doctors to pass on the information.
The Food and Drug Administration (FDA) told 23andMe in November 2013 to immediately stop marketing its Saliva Collection Kit and Personal Genome Service to consumers until it received federal marketing approval for the product. At the time, the FDA said, “serious concerns are raised if test results are not adequately understood by patients or if incorrect test results are reported.”
But Alexander said that patients were given the right under a final rule (79 Fed. Reg. 7,289) published Feb. 6 to directly access their laboratory test results. The FDA warning letter, he concluded, conflicted with the HHS’s new policy to give patients access to their lab results without physician interpretation of the results.
“These are two conflicting actions from your Department in just a few months’ time and raise questions about your agency’s commitment to making personal health information available to support medical innovation,” the senator wrote. “The conflicting decisions coming from agencies within your Department will slow down the access to or availability of novel diagnostics and targeted therapies. Targeted drug therapies rely on the availability of a wide array of diagnostic products, and consumers who want to take control of their health should have the right to their personal information to help in making personal health care decisions.”
Alexander asked Sebelius to explain the HHS’s position on “greater direct access to personal health information for patients” and to describe the criteria used to evaluate the tests described in the FDA warning letter and the final rule on patient access to test results.
Since receiving the FDA letter, 23andMe has stopped offering new consumers access to health-related genetic tests while the company moves forward with the agency’s regulatory review process. However, CEO Anne Wojcicki says she stands behind the data the company has generated for customers, noting that its lab partner adheres to strict quality standards under the Clinical Laboratory Improvement Amendments.
Takeaway: HHS policies on providing consumers with access to their own test results appear to be contradictory, believes a U.S. senator who is seeking clarification from HHS Secretary Kathleen Sebelius.
