US Senate Committee on Health, Education, Labor, & Pensions

Alexander Calls for Administration to Clarify Position on Patient Access to Personal Health Information

Says recent actions by FDA, including warning letter to genetic test maker 23andMe, indicate resistance to personal health information access

Thursday, February 20, 2014Liz Wolgemuth 202-228-4729

Nashville, Tenn., Feb. 20 – U.S. Senator Lamar Alexander (R-Tenn.), the senior Republican on the Senate health committee, today asked Health and Human Services Secretary Kathleen Sebelius to clarify the administration’s position on patient access to personal health information.

The FDA last year said in a warning letter to genetic test maker 23andMe it was taking action to stop the company from marketing certain tests directly to consumers that FDA does not trust individuals with test results, that there is a “risk that a direct-to-consumer test result may be used by a patient to self-manage.”

Earlier this month, Secretary Sebelius said in an HHS press release, “Information like lab results can empower patients to track their health progress, make decisions with their healthcare professionals, and adhere to important treatment plans.”

In a letter to Sebelius, Alexander said: “Some 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.”

Alexander said the conflict “will slow down the access to or availability of novel diagnostics and targeted therapies.” He added, “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 state the HHS position on greater direct access to personal health information for patients and also requested the criteria used to evaluate the types of tests indicated in the conflicting statements.

The full text of the letter is below:

February 20, 2014

The Honorable Kathleen Sebelius

Secretary of Health and Human Services

U.S. Department of Health and Human Services

330 Independence Avenue, SW

Washington, DC 20201

Dear Secretary Sebelius:

I write today to ask for clarity on conflicting decisions made by your Department regarding consumer access to personal health information.  This is the information age; individuals should have direct access to personal health information, and federal policies should clearly support that goal. Recent actions by the Food and Drug Administration (FDA) indicate a resistance to the importance of personal health information. 

Some 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.[1]  In a press release on February 4, 2014, you stated, “Information like lab results can empower patients to track their health progress, make decisions with their healthcare professionals, and adhere to important treatment plans.”[2]  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. FDA cautioned: “risk of serious injury or death is known to be high when patients are either non-compliant or not properly dosed,” and there is a “risk that a direct-to-consumer test result may be used by a patient to self-manage.” [3]

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 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.

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.

I appreciate your prompt attention to this request. If you have any further questions, please have your staff contact Grace Stuntz or Alicia Hennie on my staff at (202)-224-6770.

Sincerely,

Lamar Alexander

Ranking Member, Senate Committee on Health, Education, Labor, and Pensions



[1] CMS, CDC, and OCR, CLIA Program and HIPAA Privacy Rule; Patients’ Access to Test Reports, 79 Fed. Reg. 7290 (February 6, 2014).

 

     

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