Originally published August 18.
By Turna Ray
The American Bar Association has drafted a consensus statement on minimum federal and local standards that it believes direct-to-consumer genetic testing firms should follow.
The ABA "urges federal, state and territorial governments to take action against companies that fail to meet applicable requirements or that make false or misleading claims about direct-to-consumer medical genetic testing," the lawyer's group said in the resolution, which it adopted at its annual meeting earlier this month.
Tony Patterson, partner in charge of the health law section at Fulbright & Jaworski and a delegate to the ABA House of Delegates, told PGx Reporter that the resolution essentially constitutes ABA policy that would then allow the association to lobby lawmakers on DTC genetic testing issues.
Currently there is no outstanding issue or legislation relating to DTC genetic testing for which ABA intends to lobby, he said, but the organization now has a policy basis upon which to provide advice or testimony on the topic should there be any legislative action on DTC marketing of genetic tests.
"The ABA by its own constitution cannot lobby Congress, states, or others on anything we don't have a policy on," Patterson said. "In order for our folks to lobby, we needed to see if we had a policy on this topic … Now that ABA passed this resolution there is a policy on which we can lobby."
The FDA has taken regulatory action against several DTC genomics firms, asking companies such as 23andMe, Pathway Genomics, and Decode to submit their genome scans and spit kits for regulatory approval as medical devices. Several states, including New York and California, have also asked consumer genomics firms to submit additional information about their services and garner state certification in order to sell their tests to state residents.
Congress is also looking into the practices of DTC genomics firms, and the House Committee on Energy and Commerce held a hearing on the manner last year. At the hearing, the Government Accountability Office presented the results of an undercover investigation that revealed that genomic risk predictions sold to consumers by four firms — 23andMe, Navigenics, Decode, and Pathway — were contradictory for nine diseases (PGx Reporter 07/28/2010).
According to the ABA resolution, health regulators should ensure that clinical samples submitted to consumer genomics firms are analyzed at laboratories certified under CMS' Clinical Laboratory Improvement Amendments and that these companies comply with state and local requirements for genetic testing. Additionally, test results should be reviewed by "a qualified health personnel acting in accordance with relevant professional standards of care," the ABA states.
Many states require that a state-certified doctor review results before they are delivered to consumers. To meet this criterion, most DTC genomics firms employ a chief scientific or medical officer who is an MD.
The ABA also recommends that consumers be provided with the scientific evidence that underlies the genomic scans, their clinical utility, and limitations. Other critical information that the ABA said should be provided to customers includes: a plain-English explanation of what probabilities mean; a statement that genes are not the only determinants of illness; a statement that much of the genetic risk data are investigational in nature; and recommendations that customers should discuss their results with a doctor before acting on them.
These are "all pretty basic protections that ought to give no legitimate genetic testing company any substantial concerns," Patterson said over e-mail.
Due to increased regulatory action against the consumer genomics industry, some companies have abandoned the DTC model, while plenty of others still market to customers directly. Earlier this month, Johns Hopkins University's Genetics & Public Policy Center released an updated list of DTC genetic testing companies and the tests they market.
GPPC's list separates consumer genetics firms by companies that those that sell their services DTC and those that market to doctors. Among the industry players, 23andMe and Decode still market their services directly to consumers. Pathway and Navigenics have moved to a physician-marketing model.
Most of the high profile firms, such as 23andMe, inform their customers of their privacy rights. While the marketing by DTC genomics firms might suggest that test results can inform customers' lifestyle and healthcare decisions, these services also carry disclaimers that the genomic information is meant for research use, and not intended for medical decision-making.
The ABA resolution further notes that federal and state health regulators should ensure that DTC genomics firms are informing consumers about risks of potential disclosure of their personal information, and protecting the security, privacy and confidentiality of their genetic data.
Finally, healthcare authorities should ensure that "claims made and information provided by direct-to-consumer medical genetic testing companies are truthful, accurate, and not misleading," the ABA said.
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