DTC testing: mailing addresses, etc

With regard to the recent hulla-baloo about the Food and Drug Administration's panel hearings on Direct-to-Consumer geneic testing, here are some addresses and links you might be interested in if you are planning to write the FDA or Congress.

The Center for Devices and Radiological Health (CDRH) is the division of the FDA that would be responsible for DTC genetic testing. And Office of In Vitro Diagnostic Device Evaluation and Safety (OVID) is the relevant CDRH office. The CDRH director is Jeffrey Shuren. OVID's director is Alberto Gutierrez, and OVID's personalized medicine staff are headed by Elizabeth Mansfield. Use the following to contact FDA staff:
list of CDRH personnel
contact info search form.

Dr. Jeffrey Shuren
Director, CDRH
White Oak Office Building 66
10903 New Hampshire Avenue
Silver Spring MD 20993
Phone 301-796-5900
Fax 301-847-8510

Nancy Stade
Deputy Director for Policy, CDRH
White Oak Office Building 66
10903 New Hampshire Avenue
Silver Spring MD 20993
Phone 301-796-5900
Fax 301-847-8510

Alberto Gutierrez
Director of OVID
White Oak Office Building 66
10903 New Hampshire Avenue
Silver Spring, MD 20993
Phone 301-796-5453
Fax 301-847-8515

Elizabeth Mansfield
Director of Personalized Medicine
White Oak Office Building 66
10903 New Hampshire Avenue
Silver Spring, MD 20993
Phone 301-796-4664

The Commissioner of the Food and Drug Administration is Dr. Margaret Hamburg. She's probably busy, but her chief of staff is Molly Muldoon. There is a list of the commissioner's closest staff here and an address search form here.

Dr. Margaret Hamburg
Commissioner of the FDA
White Oak Office Building 1
10903 New Hampshire Avenue
Silver Spring MD 20993

Molly Muldoon
Chief of Staff, FDA
White Oak Office Building 1
10903 New Hampshire Avenue
Silver Spring MD 20993
Phone 301-796-9691

The Medical Devices Advisory Committee are consultants, not government employees or politicians. The Molecular and Clinical Genetics Panel of the MDAC is the group that met recently on March 8-9. The contact information of the Panel members is all listed here.

The FDA is under the Department of Health and Human Services, headed by Secretary of Health and Human Services Kathleen Sebelius.

Kathleen Sebelius
Secretary of Health and Human Services
200 Independence Ave. SW., room 120F
Washington, D.C. 20201
Toll Free: 1-877-696-6775

The Congressional Committees and Subcommittees most concerned in this matter are probably the House Committee on Energy and Commerce, of which the Subcommittee on Oversight and Investigations called 23andMe to testify last summer, and the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, which deals with the FDA's budget. There is also a House Energy and Commerce Subcommittee on Health. Wikipedia has updated lists of the members and chairpersons of these committees. Use www.House.gov to search for members' contact information.
House Committee on Energy and Commerce
House Energy and Commerce Subcommittee on Health
House Committee on Appropriations
House Appropriations Subcommittee on Agri...FDA and Related

Don't forget your own Congressional House Representative! Go to House.gov to learn how to write your representative.

There are also Senate Committees and Subcommittees that parallel the ones in the House as well as your own Senators.

what to write

There are multiple websites (Google 'em) that will advise you how to write a petitionary letter to the government. Please consult them.
  • Keep your letter/fax to one page only.
  • Keep your e-mails short.
  • Be polite.
  • State your purpose clearly and immediately.
  • Focus on only a few important points.
  • Give supporting evidence if you can (but not a page of references).
  • Use proper formatting and proofread.

In addressing the matter of DTC genetic testing, please be clear that you are strongly against having regulations that would require genetic testing and genome sequencing be prescribed by a health care provider, as well as regulations that would require these test results be released only to a health care provider. Dan Vorhaus' term for this type of regulation is "gatekeeper." The FDA's phrase for this is testing "routed through a clinician."

Work in President Obama's January 18 statement if you are clever.

Here's the letter I intend to send to the FDA. It can be tweaked a little for Congress as well... it's probably too long...

Dear __________

Following the FDA's March 8-9 advisory panel meetings on Direct-to-Consumer (DTC) Genetic Testing, I am writing to urge the FDA not to adopt a standard of regulation that would require a consumer's genetic information be "routed through a clinician." This requirement is unnecessary, unethical, and not in the national interest.

DTC genetic testing is already being done in the United States, yet no data exist to suggest that there have been adverse consequences from its use. Questionable anecdotes are not an acceptable reason to adopt a high level of regulation. Valid empirical data showing adverse consequences should be a minimum requirement before adopting such a strict regulatory scheme.

Curtailing an American's freedom to his or her own genetic information in favor of an untrained class of professionals is unethical. As a health care professional, I can attest that neither I nor those I work with have more than a cursory education in genetics. The situation is more problematic when the advisory panel and FDA itself are heavily populated by the same class of professionals that will benefit from the regulations.

The end of DTC genetic testing will end many incentives for U.S. innovation in this area, but it will not stop consumers from using these services as they look overseas to foreign companies. Strict regulation of genetic testing will result in sending more US dollars and jobs to China and India in exchange for no appreciable benefit.

Again, speaking as a consumer, a health care professional, and an American, I strongly urge the FDA: do not adopt a regulatory approach that would be economically stifling, restrict consumer choice, and provide no consumer safety. Do not require clinician intervention in Direct-to-Consumer genetic testing.

Thank you.

[this post was revised March 13 @ 10AM]