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A federal judge just ruled that, yes, the FDA can regulate a fish as a medicine. His written opinion is kind of a roller coaster for the mind.

Remember the GMO salmon? It was created by a company called AquaBounty back in 1989 and approved by the Food and Drug Administration in November 2015. Its sold in Canada under the brand name AquAdvantage, and the first batch intended for the U.S. market is quietly growing in an indoor facility in Albany, Indiana. Theyre expected to come to market in the U.S. sometime this year.

Or not. The fish, like most other genetically engineered plants and animals, faces adamant opposition in some quarters. Lisa Murkowski, the Republican senator from salmon countryAlaskahas slipped various riders into budget and other bills trying to throw obstacles in AquaBountys path. And theres a longstanding lawsuit brought by a coalition of salmon industry folks and environmentalists thats trying to completely overturn the approval.

The Food, Drug, and Cosmetic Act has nothing to say about genetically engineered animals. But it does give FDA the authority to regulate veterinary drugs.

That suit hit an important turning point just before Christmas, when Judge Vince Chhabria of U.S. District Court for the Northern District of California responded to requests for summary judgment in the case, threw out a bunch of claims by the plaintiffs, but let others stand, pending a separate court decision. Its worth paying attention to, not just for the sake of knowing whether the AquAdvantage is going to find its way into your grocery store, but also because it shows how tricky it can be to get the legal system to do what you want it to.

You can read the opinion for yourself. (Chhabria is the rare judge who produces opinions you can actually read with pleasure.) But to simplify a bit, heres how the judge responds to the plaintiffs main points:

Fair enough. The Food, Drug, and Cosmetic Act (FDCA) has nothing to say about genetically engineered animals. But it does give FDA the authority to regulate veterinary drugs. And FDA has issued a guidance (well talk about guidances a little later) that says that when you insert genetic material into an animal, that genetic material is a veterinary drug, and FDA gets to regulate it.

This idea isnt new. Back in 2009, using the same logic, FDA approved a goat that was genetically engineered to produce anticoagulants in its milk. Several other pharm animals were approved over the next few years that produced useful drugs in their milk or eggs.

AquaBountys DNA construct isnt essentially administered to a fish. Its reengineering a fish that hasnt yet begun its life

This is the first time the agency has used that particular pathway to approve a genetically modified animal intended to be eaten, but remember, FDA regulates lots of other sorts of drugsantibiotics are but one huge categorythat are given to animals intended for the table and which could have potential effects on the people who ultimately eat them.

Ill confess that I find something deeply unsatisfying about FDAs approach. We care about these fish as food, not as patients receiving treatment. And that means we should regulate them on that basis, not as some kind of workaround.

But that would require new legislation, which has problems of its own, so FDA has a long history of making do with the law that its got. You say you want to harvest cells from a patients tumor, use them to create a vaccine that stimulates immune reaction to the tumor, then inject them into the patients? Fine, FDA says. Thats a drug; we regulate it under the drug framework. How about if we want to take the patients own T-cells, modify them to target a cancer and inject them back into the patient? (The examples are real, by the way.) Drug. Follow the drug framework. GMO salmon? You get the idea.

FDCA says drugs are, articles (other than food) intended to affect the structure or any function of the body of man or other animals.

It makes sense. It keeps politics out of the decision making (for better or for worse). And it avoids the situation where FDA knows something needs to be regulated and cant get a law passed to authorize it. And, as Chhabria points out, if the plaintiffs prevail on this point, it may well mean that no one regulates GMO salmon and that manufacturers are free to do what they wantwhich is exactly the opposite of what the plaintiffs want.

This sounds like a good argument. Drugs are things that treat diseases and relieve pain. AquaBountys DNA construct isnt administered to a fish per se, and it isnt curing anything. Its is reengineering a fish that hasnt yet begun its life.

But as Chhabria explains, for purposes of the law, it doesnt matter what the dictionary thinks a drug is or what common sense thinks it ought to be. What matters is how the statute defines it, and FDCA says drugs are, among other things, articles (other than food) intended to affect the structure or any function of the body of man or other animals.

Drug is a defined term under the FDCA, writes Chhabria, and this definition is broad and dynamic by design, not by linguistic oversight. As the Supreme Court has long recognized, the word drug is a term of art for purposes of the Act, encompassing far more than the strict medical definition of that word.

The FDA asserted that the old rules for veterinary drugs were still in effect, and how companies might go about filing for marketing approval.

Heres where things get a little weird. Lets assume that FDA has the authority to regulate genetically engineered salmon. Under Administrative Procedures Act, people are allowed to file lawsuits over regulations.

But has the FDA actually issued regulations in regard to salmon? No, says Chhabria. It has issued guidance, and thats different.

Issuing regulations is a complicated business. Theres a lengthy, arduous procedure, with notifications of planned rulemaking in the Federal Register, formal publications and comment periods, and often hearings. But FDA didnt issue a new rule about GM salmon. Instead, it asserted that the old rules for veterinary drugs were still in effect, and it issued a guidance explaining the agencys current thinking on how the rules apply to genetically altered animals, and how companies might go about filing for marketing approval. Its not a binding document. You could, for instance, come up with a different approach to filing for approval for a GM animal, and if FDA liked what you did, theres nothing in the guidance that prevents them from accepting your application. But the guidance lets everyone know whats likely to happen, at least for today. Its not a rule, but for most practical purposes, it might as well be one.

FDA issues lots of guidances. They typically come out in draft form, and then are finalized based on outside input. But the process of finalizing can take years, or even decades, and sometimes it never comes. A few years back FDA withdrew close to 50 draft guidances, including a few that dated to the late 1980s, that never got finalized and had been rendered obsolete by changing technology and standards.

But heres the thing: Under the law, while an agency can be sued over a rule, the only way it can be sued over a guidance is if the guidance has a direct and immediate effect on the complaining parties or requires immediate compliance. Since the plaintiffs in the case are mostly environmental groups and people in the salmon industry who have no intention of marketing GM salmon, the law doesnt require them to do anything, and they face no legal penalties, so they cant sue.

The question is whether the agency can decline to approve a product based on environmental concerns and, if so, what standards would apply.

At this point, barring appeals, the whole first part of the plaintiffs case has been tossed out. Were left with the claim that really matters: that when FDA approved AquaBountys salmon, it did not appropriately consider potential environmental harms (for instance, the possibility that the engineered salmon would crossbreed with wild Atlantic salmon to the detriment of that species). Judge Chhabria didnt rule on this issue (its going to be decided separately), but he did raise a few points:

First, its not entirely clear whether FDA can decline to approve a drug based on environmental concerns. The Food Drug and Cosmetic Act instructs FDA to consider the safety of veterinary drugs, but heres how it defines safety:

In determining whether such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof, the Secretary shall consider, among other relevant factors, (A) the probable consumption of such drug and of any substance formed in or on food because of the use of such drug, (B) the cumulative effect on man or animal of such drug, taking into account any chemically or pharmacologically related substance, (C) safety factors which in the opinion of experts, qualified by scientific training and experience to evaluate the safety of such drugs, are appropriate for the use of animal experimentation data, and (D) whether the conditions of use prescribed, recommended, or suggested in the proposed labeling are reasonably certain to be followed in practice.

So its clear that FDA can refuse to approve a drug that harms the animal or the people who eat the animal. (If you were wondering what they did to ensure that level of safety, heres the agencys explanation.) But environmental damage? Much less clear; expect to hear a lot of discussion of among other relevant factors as the case proceeds.

The fact is that FDA already has considered at least some environmental factors in approving the AquaBounty salmonfor example, it requires that the fish be raised in land-based facilities to make it difficult for fish to escape and mingle with wild salmon populations. (AquaBounty already has taken the step of sequestering the small cohort of male fish it needs for egg production and sterilizing its fish intended for food, which are all females.) The question is whether the agency can decline to approve a product based on environmental concerns and, if so, what standards would apply. One potential glitch as the trial moves forward: A judge could rule that FDA has no authority to make decisions based on environmental impact and no ability to impose conditions on companies whose products may be environmentally harmful but safe under the terms of the FDCA. Who would be in charge then? Its not clear, but the answer might be nobody.

But thats another days concern. For the moment, barring the possibility that a higher court reverses Chhabria, FDA has the right to regulate genetically altered animals under its pathway for veterinary drugs, the rest of the suit will continue, and a batch of AquAdvantage salmon continue to fatten up down in Indiana.

They may have thought that being raised in a tank meant they didnt have to swim upstream against raging currents. They were wrong.

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GM salmon leaps another legal hurdle. Next up: Another legal hurdle - The New Food Economy

This entry was posted on January 13, 2020 at 3:48 pm and is filed under Legal Issues Genetic Medicine. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed. |