| GE animals are regulated under the New Animal Drug provisions of the Federal Food Drug and Cosmetic Act (FFDCA). Typically, an animal drug manufacturer first goes for permission for "investigational use" for their drug (INAD - Investigational New Animal Drug) so they can do the research to ultimately get the drug approved. Then they file a NADA - New Animal Drug Application. If you want all of the details on what goes into the application, you can find them in the FDA's CVM GFI #187 Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs.
In legal gobbledygook, here's what I just said: "Generally under the Act, a new animal drug is "deemed unsafe" unless FDA has approved a new animal drug application (NADA) for that particular use, unless the drug is only for investigational use and conforms to specified exemptions for such use under an Investigational New Animal Drug (INAD) exemption (21 USC 360b(a)(1), (a)(3)), or unless the drug is used in conformance with regulations promulgated under sections 512(a)(4) or (5) of the Act (21 U.S.C. 360b(a)(4) or (5))."
For the NADA, the "animal drug" is the heritable recombinant DNA at a specific site in the genome. In the investigational phase, it's OK to have different genes or different locations in the genome where you put those genes, because the FDA assumes that you're researching which genes you want and where you want them to ultimately go. But for the actual NADA application, you've got to stick to one set of genes you're adding, and one location in the genome where you're adding them.
They add that because it's likely that the animals that will be commercialized will be the offspring of the ones that had the genes added to them, the animals used for testing should be as close to the generation that will be commercialized as possible. Also, you must prove that the traits from the genes you have added basically stay the same from one generation to the next.
Also, in accordance with National Environmental Policy Act (NEPA), FDA requires an Environmental Assessment on the new animal drug (or GE animal, in this case) included in the NADA application (or a claim of categorical exemption).
Within one hundred and eighty days after the filing of an application pursuant to subsection (b), or such additional period as may be agreed upon by the Secretary and the applicant, the Secretary shall either (A) issue an order approving the application if he then finds that none of the grounds for denying approval specified in subsection (d) applies, or (B) give the applicant notice of an opportunity for a hearing before the Secretary under subsection (d) on the question whether such application is approvable. If the applicant elects to accept the opportunity for a hearing by written request within thirty days after such notice, such hearing shall commence not more than ninety days after the expiration of such thirty days unless the Secretary and the applicant otherwise agree. Any such hearing shall thereafter be conducted on an expedited basis and the Secretary's order thereon shall be issued within ninety days after the date fixed by the Secretary for filing final briefs.
So, the NADA is filed. What next? The Secretary (of HHS) has 180 days (unless a different time period is agreed to by Secretary and the applicant) to either approve the application OR give the applicant notice of a hearing to determine whether or not the application can be approved. If the Secretary offers a hearing, the applicant has 30 days to accept it, and then the hearing must begin within 90 days after the end of the 30 days ("unless the Secretary and the applicant otherwise agree"). And, if the hearing still doesn't prove that the drug is safe, the Secretary can disapprove of the NADA application.
And yet, with all of that information, none of it says where we are in the process right now, where the VMAC meeting fits in, and what that preliminary decision that the GE salmon is safe and won't harm the environment that's already been issued actually was.
The best information out there, actually, can be found here (hat tip to blogger count). Basically, the FDA is in the process of a relatively secretive approval process and the VMAC meeting is part of that. The VMAC decision is not binding, but it will be an important step towards the approval of the GE salmon. So that's where we are. And given the 180 day window from the time the application was submitted to approval, we're probably pretty close to getting a final decision (either for an approval or a hearing) from the FDA. |
