By Jay W. Cormier –
Just before President Trump took office, FDA issued a series of documents detailing how it would regulate the products of gene editing. Specifically, FDA issued policy statements in the form of an announcement on its website and an article in the FDA Voice, FDA’s official blog. FDA also issued two draft guidance documents and accompanying documents. Those draft guidance documents cover FDA regulation of animals whose genomic DNA have been intentionally altered (the draft guidance can be found here, as well as a Q&A document) and the scope of FDA’s authority over mosquito-related products (the draft guidance can be found here).
These documents continue the series of recent efforts to clarify how the Federal government intends to regulate 21st-century biotechnology. The documents fall in line with the September release of the National Strategy for Modernizing the Regulatory System for Biotechnology Products (a copy of which can be found here) as well as the more recently released update to the Coordinated Framework for the Regulation of Biotechnology (a copy of which can be found here on our website now that the Trump Administration has, at least for now, removed it from the White House website where it used to be found).
Although the series of documents were highly anticipated and some had hoped for a change to the regulatory approaches that have been in place for over a decade, we find that little is changed from how FDA has approached these products in the recent past. So, while it is helpful to have greater clarity around these issues, one word sums up our overall impression: meh.
Regulation of Genetically Engineered Animals
It has been eight years when FDA’s Center for Veterinary Medicine (“CVM”) issued its final guidance regarding the regulation of animals that have been genetically engineered via recombinant DNA (“rDNA”) technology. For those who live or work in the Washington area, it should come as no surprise that the final of the original guidance was issued on the last working day of the George W. Bush administration and that this update should be issued, if only in draft form, on the last working day of the Obama administration. The issue of genetically engineered (“GE”) animals has been highly controversial both inside and outside of The Beltway (see our prior post discussing Congressional activity on the subject, here, as well as lawsuits challenging FDA’s authority in this area, here).
The most significant substantive change to the draft guidance from the prior final version of the guidance is that the draft guidance explicitly includes all animals whose genomes have been intentionally altered, no matter how the alternation occurred. The prior version, on its face, was limited to animals genetically engineered by rDNA technology. Newer biotechnologies, such as the CRISPR/Cas system (see discussion of these technologies here), do not necessarily use rDNA technology, and some companies and academics have argued that these “genome editing” technologies fall outside the scope of FDA guidance and FDA’s authority. Since at least 2015, however, CVM has been publicly stated that all genome editing techniques met the statutory definition of a new animal drug and, therefore, were under FDA’s statutory authority (see, for example, CVM’s presentation to the National Academy of Sciences’ Roundtable on Science and Welfare in Laboratory Animal Use, here). So, objections regarding FDA’s revisions in the draft guidance are a bit late to the party. Setting aside potential issues of podium policymaking, the draft guidance merely clarifies and properly issues a statement of FDA’s pre-existing policies.
When issuing the draft guidance, FDA asked in its Notice of Availability for public comment not only on the document itself, but specifically with respect to two questions:
- How to refer to the animals subject to the draft gudiance. In the past, FDA has used the term “genetically engineered” to refer to animals containing recombinant DNA constructs intended to alter the structure or function of the body of the animal. In the draft guidance, CVM uses the phrase “animals whose genomes have been altered intentionally.” In the opinion of your author, this term is clunky, and unnecessarily confusing. From a scientific perspective, all such animals are genetically engineered – after all, there genetics have been changed by design, which seems to be the very definition of genetic engineering. CVM asks the public to weigh in on this definitional issue.
- Whether there is any existing empirical evidence demonstrating that certain types of genome editing may pose minimal risk, and not require the type of regulatory oversight contemplated by the draft guidance. This could include categories of animals or types of genetic changes that are likely to pose minimal risks to the animal, to food safety concerns, or to the human environment.
Comments on the draft guidance should be submitted by April 19th.
Regulation of Mosquito-Related Products
The other draft guidance that FDA issued discussed when mosquito-related products would be regulated by FDA under the FDCA and when products would be regulated by EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”). The draft guidance does not change the existing regulatory jurisdiction of either agency, but rather clarifies for companies which agency will take jurisdiction under which circumstances.
In brief, CVM does not consider mosquito-related products as new animal drugs when those products are intended to function as pesticides by preventing, destroying, repelling, or mitigating mosquitoes for population control purposes. Accordingly, such products would be regulated by EPA under FIFRA. All mosquito-related products that are intended to prevent, treat, mitigate, or cure disease in animals or man that do not function as pesticides will be regulated by FDA as drugs.
Comments on this mosquito-related products draft guidance should be submitted by February 21st.
With all the uncertainty that exists with any new Administration, one thing in the area of genome editing is certain – the federal government will continue to seek to regulate this technology. All parties, even if they agree with the draft guidance documents, are encouraged to submit comments to FDA expressing their views.