The Big O and his FDA Regulators

One of the Obama administration’s biggest promises was bringing greater transparency to Washington. Advocacy group Genetic Alliance is trying to make sure the FDA adheres to Obama’s promise brings reform to genetic testing, an area which had unsurprisingly come under criticism for lack of regulation during the Bush years.

At a hearing sponsored by the FDA Transparency Task Force, Genetic Alliance asked that the FDA create a public registry for genetic tests “to enable transparency and promote informed decision making for consumers and providers,” including “the myriad of genetic, genomic, and pharmacogenomic testing available to the US market.” Genetic Alliance believes that the registry should be overseen by FDA and that the information should stored at the National Center for Biotechnology Information so that it could be integrated with other genetic resources. Interestingly, Genetic Alliance also called on the FDA to release warning letters it sent to genetic testers for not following their guidelines, to better inform consumers about which companies should merit concern.

The Genetic Alliance recommendations are good, but they do not address one of the bigger debates- increased FDA scrutiny of lab-developed testing. Currently FDA does not regulate most lab-developed tests (LTDs), which are sold as diagnostic services. The agency consistently regulates in vitro diagnostic test kits (IVDs), sold as packaged products.

Addressing this discrepancy actually began in the 11th hour of the Bush administration. “There is a major gap in the oversight of genetic tests when it comes to the evaluation of clinical validity. ... A truck can drive through that hole,” says Reed V. Tuckson, M.D., an industry man tapped by Bush’s Department of Health and Human Services to head a panel drafting a better model for genetic test oversight.

The fissure here, from what I understand, has pitted certain big pharmas against each other. Manufacturers who devote resources to obtaining FDA approval for their commercial products are understandably frustrated that the FDA’s inability to handle the explosion in labs providing genetic testing may undercut their bottom line.

The arguments against regulation are familiar- not enough resources, not enough legal authority. Industry groups feign concern for “the ability of small labs to handle compliance,”sounding a bit like agribusiness hiding behind the fictional little Iowa farmer. Steve Gutman, director of the FDA’s wordy Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) disputes these claims, noting that the FDA provides plenty of educational workshops on compliance, also noting, “Quality is quality, so if small labs are doing a good job now then they will not have difficulty complying.”

Gutman notes that the main differences in the requirements currently guiding the two types of testing are design control requirements and “the way corrective and preventative action is performed.” That sounds like a pretty big difference in the regulatory context, no?

Various task forces have been working since late 2008 to address these problems, but in the summer of 2009 we don’t seem much closer to a final answer. In a field where one of regulation’s most cited challenged is responding quickly to dynamic changes in the field, the endless panels, task forces and review boards do not paint an encouraging picture.

The final word goes the Director of Public Health Genomics at the Centers for Disease Control and Prevention, Muin Khoury, M.D. “The committee can ... describe what the ideal is, which is truth in advertisement, minimum standards of clinical validity, analytical validity and quality control…Clinical utility is tough. But you need a threshold below which stuff just shouldn't be going to the market.” Amen, Muin. Let’s all get to work on finding that threshold and making it apply to all genetic testers.

Further Reading:

Two posts from Genome Web:
http://www.genomeweb.com/dxpgx/genetic-alliance-asks-fda-public-genetic-test-registry
http://www.genomeweb.com/blog/cms-sheds-light-plan-enhance-oversight-genetic-ldts

Insightful, albeit somewhat dated article (2006) from DNA policy: http://www.dnapolicy.org/resources/Issues_in_Science_and_Technology.pdf

Highly technical debate on lab testing dispute: http://www.medicaldevicestoday.com/2008/02/fda-genetic-tes.html