Thursday, July 22, 2010

FDA regulation and our genetic information

The US government's Food and Drug Administration (FDA) held a two-day conference on 19-20 July in Washington DC - see FDA's public meeting regarding Oversight of Laboratory Developed Tests (LDTs) for background and details.

Katherine Borges is the Director of ISOGG, the International Society of Genetic Genealogy, a non-profit organization of over 7,000 members spread throughout the U.S. and 60 other countries. She spoke at the FDA conference against refulation of genetic testing for ancestral and family history purposes.

The text of Katherine's talk is on Megan Smolenyak's Huffington Post article titled Don't "Protect" Us From Our Own Genetic Information .

Katherine's recommendations were:

"The great majority of our ISOGG membership feels strongly that any expansion of FDA regulatory authority that would have the effect of preventing consumers from ordering DTC tests would be unwise and unnecessary. At a minimum, no action of that sort should be taken without credible, compelling scientific data to support such a move. Relevant studies of this nature and quality are currently being conducted."


"The general view of ISOGG's members is that regulatory agencies should not stand between a consumer who wishes to collect data on their own genome, and labs that can provide that service. The genome of an individual consists fundamentally of information, and every individual in a free society has an absolute right to information about their own genome from a source of their choosing."

Please read the whole article. It is important to all of us in the genealogy and family history community.

There is a petition online for consumers to express their opinion about this issue. It reads:

"We, the undersigned, as makers, citizen scientists, and people with a spirit of curiosity:
o Demand unrestricted access to our genetic information
o Believe individuals have the right to seek out, purchase, and interpret their own genetic information
o Don't want to be required to consult a doctor or genetic counselor before accessing our genetic information
o Believe that people can make informed decisions about the usefulness, quality and actionability of genetic information
o Think Direct-to-Consumer genetic testing companies are taking the first steps in getting relevant genetic information to a wide audience, and that burdensome regulation will stifle innovation in this field
o Support legislation to ensure privacy and prevent discrimination based on genetic information"

The Personal Access to Genetic Information petition is here. If you agree with the petition, please take the time to click on the link above and sign it.

My thanks to Megan for publishing Katherine's talk, and to Katherine for speaking out effectively and forcefully on this issue.

1 comment:

Megan Smolenyak Smolenyak said...

Thanks so much for sharing this with your readers, Randy. This is a truly important issue for the genealogical community.