Since DTC genetic testing is a patient- and consumer-advocacy issue, I hope that nursing organizations will take the opportunity to let the FDA know that they oppose a "routed through a clinician" level of regulation that would take away Americans' rights to have access to information about their own genes.
The American Medical Association has already let the FDA know its position. The AMA believes all genetic testing should require a doctor's prescription and the results of genetic tests should only be available under a doctor's supervision, for patient safety. However, as various bloggers have pointed out, direct-to-consumer genetic testing has been a reality for several years, and the only studies of the issue have shown no harm to patients. An evidence-based approach to regulation contradicts the AMA's position.
As I have argued in another post, the health risk information provided by genetic testing is non-diagnostic and similar to the health risk information provided by nutritional information. Therefore, a standard of regulation similar to nutrition facts and health claims on food labeling is more appropriate to genetic testing companies than requiring doctor supervision for genetic testing. I hope nursing organizations would take a similar view.
about FDA docket comments
The Food and Drug Administration maintains an independent committee of expert science advisors. This committee's Molecular and Clinical Genetics Panel (MCGP) recently met over a 2-day period to hear presentations about and to discuss DTC genetic testing before making its recommendation to the FDA on regulating DTC testing.
Government agencies solicit official statements, called comments, from interested parties as part of fact-finding missions before making regulatory decisions. These comments are solicited through the federal government's official journal, the Federal Register. The Federal Register publishes an indentification number, called a docket number, and organizations wishing to submit comments use this docket number to tell federal agencies which regulatory decisions they are commenting on. Comments are submitted online and can be read by the public at www.regulations.gov. This website is searchable by docket number.
Comments for the MCGP meeting were solicited under federal docket number "FDA-2011-N-0066," which can be seen at the following web address:
http://www.regulations.gov/#!docketDetail;D=FDA-2011-N-0066
The Federal Register call for comments on the MCGP meeting can be read here (click on the PDF there for a scan of the Federal Register page).
Comments are meant to be made by organizations and institutions with a vested interest in the outcome of the federal regulatory decisions, not by individual citizens. Nursing organizations, which have a vested interest in any regulations affecting patient rights, should submit official comments soon. Individual nurses and health care professionals can send letters to the FDA and to Congress.
read more about DTC genetic testing
Here are some resources for reading more about Direct-to-Consumer genetic testing:
- This 23andMe webpage, explains what direct-to-consumer genetic testing is, and how it works.
- The International Society of Nurses in Genetics has released a statement on DTC genetic testing: as noted above, their main concern over DTC testing, the safety of patients, has been shown through evidence not to be a problem!
- Ann Maradiegue testified on behalf of the ANA at the MCGP meeting March 8-9. Although she implied that she supports a "routed through a clinician" standard of regulation as against a lower standard of regulation, she did not state this explicitly. The ANA and other nursing organizations should take this opportunity to undo the damage done by Dr. Maradiegue's testimony and state explicitly their support for regulation without a "routed through a clinician" standard.
- You can read all my posts about DTC testing, in which I lay out the position that consumers need assurances about genetic testing that would parallel the FDA's system of food regulation, not regulations appropriate for potentially dangerous drugs and equipment.
- Genetics lawyer Jennifer Wagner has written an open letter to Congress about FDA over-reach in this area.
- Lawyer Dan Vorhaus provides excellent, if very detailed, coverage of the MCGP meeting and the whole issue of DTC genetic testing
- Geneticist Dan Macarthur comments on the AMA's position
The author of this blog is a registered nurse who works in an ICU in the northeastern United States. You can connect on LinkedIn.
[revised March 13 @5PM]