Biotech Firms Caught In Regulatory No Man's Land
Companies making genetically modified animals face a regulatory morass in this country. It's not always clear which federal agency has responsibility for regulating a particular animal, and even when one agency does take the lead, the approval process can drag on for years.
The companies say this uncertainty means their technologies may die without ever being given a chance.
Take the case of the British company Oxitec. It has developed a genetically modified mosquito that the company says can be used to combat a disease called dengue.
Dengue is potentially fatal, and there is no treatment or vaccine. Dengue is not common in the United States, but it could be, because we have plenty of the species of mosquito that transmits it. There have been sporadic cases in Texas and Florida, so controlling this mosquito is crucial for keeping dengue out of the United States.
It's sending a very strong message to the investment community and to people trying to develop innovative new products that there really is not a functional regulatory paradigm.
Luke Alphey, chief scientific officer of Oxitec, says the basic idea is very simple. The company has made genetically modified male mosquitoes that are sterile. When these modified males mate with normal females, there are no offspring.
"Over time, with periodic releases or successive releases of these sterile males, the target population will collapse," says Alphey.
No mosquitoes, no dengue.
Florida officials agreed to let Oxitec test its mosquitoes in Key West. So in 2009, Oxitec started asking which federal agency it needed to get approval from. The U.S. Department of Agriculture said, 'We're it,' so in March 2010, Oxitec submitted an application to import its mosquitoes from the U.K., and waited to hear back. And waited.
Finally, 18 months later, Oxitec heard back from the USDA. Bad news. The agency said, "We're not the right agency. Try the Food and Drug Administration."
How is it possible that it takes a federal agency 18 months to decide it's not the right one to regulate something?
"Well, the basic issue goes back to the problem of how the government first established oversight over genetically modified organisms," says Eric Hallerman, a professor of fisheries and wildlife at Virginia Tech. "There is no particular act that establishes government authority to do it."
Instead, in 1986 the Reagan White House decided to use existing laws, such as the Federal Insecticide, Fungicide, and Rodenticide Act and the Federal Food, Drug and Cosmetic Act, as the basis of regulating genetically modified organisms. This has led to some strange circumstances. For example, for the purpose of regulation, the FDA considers a genetically modified mosquito to be a new animal drug.
But if Oxitec is frustrated, consider the plight of a Massachusetts company called AquaBounty. It has created a genetically modified salmon, a fish that is also a drug as far as the FDA is concerned. The salmon grows faster than wild salmon, something that could appeal to fish farmers.
AquaBounty has been trying to get FDA approval to market its salmon for more than a decade.
Hallerman was on a panel of scientists the FDA asked to evaluate whether the AquaBounty salmon were safe. In September 2010, the panel met and told the FDA yes, it would be OK to approve the salmon for sale.
"I was thinking at that time that they were going to come out with some sort of a decision sometime that winter," says Hallerman. "Well, here we are at the next winter."
The point here isn't whether AquaBounty's salmon or Oxitec's mosquitoes really are safe — there are some legitimate scientific questions about that. The point is that the companies are in a regulatory never-never land.
"It's sending a very strong message to the investment community and to people trying to develop innovative new products that there really is not a functional regulatory paradigm," says Ron Stotish, president of AquaBounty. Stotish says any answer would be better than none at all.
But even if the FDA does approve the salmon, there's yet another hurdle. Mark Begich, the Democratic senator from Alaska, isn't convinced the salmon is safe, and he says that approving it would threaten his state's wild salmon fisheries.
"We don't need to go down this path, and I believe that's a position we need to take," says Begich.
He has introduced legislation that would make it unlawful to ship, transport, offer for sale, sell or purchase genetically altered salmon or other marine fish.
If such a piece of legislation became law, it would, if nothing else, lighten FDA's workload.
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