Wired has a great article by Daniel MacArthur about how bad the government is at actually using regulation properly:
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, 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.
MacArthur makes a good case for light at the end of the tunnel, however, and suggests that recent steps by Obama make it look as if a more consumer friendly model of regulation is in the works. Fingers-crossed.
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