— Written By

Nature Biotechnology 33, 1213 (2015) doi:10.1038/nbt.3438
Published online 09 December 2015

Here’s hoping that a proposed shakeup of US regulations will mean that new biotech products avoid AquaAdvantage salmon’s two-decade upstream struggle to regulatory approval.

November marked the first US approval of a genetically engineered food animal. AquaBounty Technology’s salmon, genetically engineered to constitutively express growth hormone, has had a long journey; 20 years, two months and five days to be exact, from investigational new animal drug submission to approval. It has negotiated the eddies of stakeholder deliberations and public consultations, swum in ever-decreasing circles while agencies wrangled over jurisdiction and elaborated new rules, and leapt through advisory committee hoops until finally pronounced “as safe as food from conventional Atlantic salmon,” only to be caught in three years of citizens’ petitions and political stonewalling before its final release last month. All this suggests that the US regulatory system for biotech—otherwise known as the Coordinated Framework for the Regulation of Biotechnology—may not be fit-for-purpose when it comes to novel biotech products that fail to fit existing categories.

This may be one reason why the US Science and Technology Policy Office (OSTP) has started to update the Coordinated Framework. OSTP is seeking feedback on (among other things) which agency has statutory authority over which new types of products, whether overlapping responsibilities among agencies need streamlining, and how well communication between the agencies and consumers, industry and other stakeholders has worked. It has already held a public meeting on the issue (p. 1221)

Read more.