By Jay W. Cormier –
As we reported previously, just before President Trump took the oath of office, FDA issued two guidance documents regarding its approach to the regulation of genetically engineered (“GE”) animals. One of those guidance documents was a revision of a 2009 guidance document that, for the first time, set up a formal review paradigm for GE animals. The guidance, entitled CVM Guidance for Industry #187 – Regulation of Intentionally Altered Genomic DNA in Animals (the “Draft Revised Guidance”), formally expanded the scope of the prior version of the guidance to explicitly state that FDA’s review paradigm for GE animals would apply to all GE animals, regardless of the molecular tools used to produce those animals.
Earlier this week, FDA announced that it is extending the comment period for the Draft Revised Guidance by an additional two months. Comments must now be submitted by June 19, 2017.
This is an important extension for several reasons. First, the area of GE animal regulation is not without its detractors. Some believe that these animals pose little risk and should have less regulatory oversight than FDA currently imposes. Others have sued FDA saying that FDA regulatory oversight is so lacking that it presents a danger to public health and the environment. Thus, FDA’s approach is under attack by both sides of the social/political spectrum. The extension provides additional time for all voices to be heard by allowing more time for disparate groups and interests to file comments.
Given that parties that oppose the Draft Revised Guidance are motivated to provide comments, it is important for parties that are in favor of the Draft Revised Guidance to also provide comments so that the public record includes an accurate representation of the various opinions of industry and the public at large.
Second, in FDA’s Notice of Availability [https://www.federalregister.gov/documents/2017/01/19/2017-00839/regulation-of-intentionally-altered-genomic-dna-in-animals-draft-guidance-for-industry-availability] of the Draft Revised Guidance, FDA asked the public “whether there is any existing empirical evidence demonstrating that certain types of genome editing may pose minimal risk.” Despite those who have asserted for years that genome editing poses little or no risks, FDA’s request for information is almost rhetorical. As far as your author is aware, the science of genome editing simply has not advanced to a stage where data exists to support an a priori finding of minimal risk for an entire class of genomic changes. The genome editing community is working feverishly to improve the accuracy and precision of their molecular tools. The day will come when it is possible to make single small changes to a genome without off-target changes, but we aren’t there yet. If there is data to support a finding that certain types of genome editing pose minimal risk, submitters of such data will welcome the extra time to collect, organize, synthesize, and report such data to FDA.
As with any draft guidance document, we strongly encourage all parties whose products are or may be included under the scope of the Draft Revised Guidance to submit comments to FDA. So, if you were rushing to pull something together before next week, the extension is a welcome opportunity to put together additional thoughts and comments.