Personalised Genomic Testing and the FDA: Getting Regulation Right

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The recent initiatives by the FDA kindled debate about the legal authority of the agency to regulate genomic testing, as well as about the potential effects that such regulation may have on discovery and innovation.9-13 Skeptics raise important concerns, but there is little doubt that the FDA has ample power to impose at least some new regulatory requirements on genomic testing — enough, in any event, to make laboratory directors squirm. The question is not whether the FDA can regulate genomic testing but whether the FDA can regulate it well. Does the FDA have the correct set of statutory powers to make genomic technologies safe and effective for consumers — persons undergoing testing, whether as patients, research participants, or direct purchasers — while still fostering innovation? We believe the answer is “no.” To press forward with the powers the FDA now has could subject genomic testing to counterproductive regulatory burdens that may — ironically — diminish consumer safety and chill innovation. Yet a relatively modest set of statutory reforms that builds on concepts the FDA already has developed for drugs and other medical devices could position the agency to play a crucial and constructive role.


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