FDA Meets With Industry, Experts To Discuss Future of Consumer Genetics

2010 was a horrible year for the fledgling consumer genetics industry. After several years of largely benign neglect from US regulatory bodies, an announcement by testing company Pathway Genomics last May that it would be offering its products on the shelves of US drug-store giant Walgreens sparked a disproportionate and confused response from the FDA, […]

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FDA2010 was a horrible year for the fledgling consumer genetics industry. After several years of largely benign neglect from US regulatory bodies, an announcement by testing company Pathway Genomics last May that it would be offering its products on the shelves of US drug-store giant Walgreens sparked a disproportionate and confused response from the FDA, followed in July by a vicious Congressional hearing into the industry and a damaging - but highly flawed - report from the US Government Accountability Office. By the end of the year, at least three major players in the direct-to-consumer (DTC) genetic testing industry (Pathway, Navigenics and Counsyl) had abandoned DTC marketing entirely in favour of offering their products solely through doctors and employers. (For a thorough review of the regulatory history of the industry, check out this excellent piece at Genomics Law Report.)

While there's little doubt that the consumer genetics industry needs purging of scammers and bottom-feeders, the regulators' crackdown frequently targeted the high-profile, generally responsible companies who deserved it least. Rather than taking simple, targeted steps to punish the bottom-feeders and help consumers make informed decisions, the FDA and its ilk have created an ongoing and stifling environment of regulatory uncertainty around an important engine of innovation for the embryonic field of genomic medicine.

In the context of the agency's clumsy and heavy-handed approach to the field thus far, supporters of genetic access would be forgiven for a shudder of foreboding on the eve of an FDA hearing into the DTC genetics industry that will take place in Maryland over the next two days. As someone who has responded rather emotionally to attacks on DTC genetics in the past, I confess to some trepidation myself. However, as Dan Vorhaus argued last month, there are now good reasons for cautious optimism about the regulatory future of the industry.

Firstly, a key criticism of DTC genetic testing - that it could harm customers by providing them with disease risk information they were unprepared to deal with - was seriously undermined by a survey of over 2,000 recipients of DTC genetic disease risk profiles published last month in the New England Journal of Medicine, which showed no evidence for increased anxiety as a result of obtaining genetic testing results. That fits with previous studies showing that disclosure of increased genetic risk for Alzheimer's disease has no detectable effect on anxiety or depression levels. While long-term follow-up studies must still be done, the evidence now available indicates that early adopters of consumer genetic testing are at minimal risk of psychological harm as a result; and the critics of the industry have lost one crucial strategic edge in their campaign of fear, uncertainty and doubt.

Secondly, the political winds are changing direction, and the new breeze is unfavourable for the HMS Bureaucracy. Back in January US President Obama announced a new executive order seeking to reduce the burden on companies of unnecessary regulation. In an accompanying op-ed piece in the Wall Street Journal the President argued for a philosophy of regulation involving greater consultation and fewer restrictions on consumer choice:

...creating a 21st-century regulatory system is about more than which rules to add and which rules to subtract. As the executive order I am signing makes clear, we are seeking more affordable, less intrusive means to achieve the same ends—giving careful consideration to benefits and costs. This means writing rules with more input from experts, businesses and ordinary citizens. It means using disclosure as a tool to inform consumers of their choices, rather than restricting those choices.

The FDA's meeting over the next two days is a nod to Obama's directive for broader consultation. Whether the agency will heed the President's second call - for clearer disclosure rather than paternalistic restriction - remains to be seen, but in the absence of any compelling evidence that DTC genetic testing causes harm it will be difficult for them to reasonably justify any major restrictions on the autonomy of consumers to examine their own genomes.

It's unlikely that we'll see any clear decisions made over the next two days. However, I'm hopeful we'll see an emerging consensus that the way forward is not to lock the public away from genetic information, or force them to seek a doctor's permission to learn something about themselves, but rather to adopt the kind of measured, light-touch regulation that I have argued for along with Dan Vorhaus, Caroline Wright and others: an approach based on firming up standards for laboratory testing, enforcing existing consumer protection laws to punish false advertising, and encouraging full, transparent disclosure by companies of the evidence supporting their tests.

That type of sensible outcome would be bad news for professional medical paternalists like the American Medical Association, who recently pleaded with the FDA to save their traditional monopoly over genetic testing through regulatory enforcement, but it would be good news for consumers.

I'll be monitoring the FDA meeting as closely as I can, but sadly from a distance. Those of you on Twitter can keep an eye on the #fdadtc hashtag for real-time updates from Dan Vorhaus and other attendees.

Added in edit: You can get more information about the meeting, including the agenda (PDF), from the FDA's website. Dan Vorhaus, who will be presenting at 10:45am, has an excellent post up outlining the key points that the meeting needs to address (along with the slides for his presentation). All of the public submissions made prior to the meeting, including the AMA's desperate plea for paternalistic regulation, are also available.