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Biotech Firms Caught In Regulatory No Man's Land

Jan 1, 2012
Originally published on January 3, 2012 12:20 pm

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.

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.

Copyright 2017 NPR. To see more, visit http://www.npr.org/.

LINDA WERTHEIMER, HOST:

A lot of companies want to use genetic engineering to make the world a better place - at least, that's their claim. But several of them have hit a hurdle they say can kill their technology before it gets a chance.

NPR's Joe Palca has this story about two companies that have run into regulatory roadblocks.

JOE PALCA, BYLINE: Dengue is a potentially fatal disease. There's no cure, and no vaccine. Dengue isn't common in the United States, but it could be. That's because we have plenty of the species of mosquito that transmits dengue, and there have been sporadic cases in Texas and Florida. So controlling this mosquito is crucial for keeping dengue out of the United States. The British company Oxitec thinks it knows how to do that.

LUKE ALPHEY: So the basic idea is very simple.

PALCA: Luke Alphey is chief scientific officer of Oxitec. The company has made a genetically modified mosquito, where the males are all sterile. When the genetically modified males mate with normal females, there are no offspring.

ALPHEY: Over time, with periodic releases or successive releases of these sterile males, the target population will collapse.

PALCA: 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 their mosquitoes from the U.K.

And they waited. And they waited.

(SOUNDBITE OF SONG, "THE WAITING")

PALCA: Finally, 18 months later, Oxitec heard back from the USDA. Bad news. They said, we're not the right agency; try the Food and Drug Administration.

What's that about? I asked USDA to explain its decision, but…

(SOUNDBITE OF SONG, "THE WAITING")

PALCA: Haven't heard back from them yet. How is it possible that it takes a federal agency 18 months to decide it's not the right one to regulate something?

ERIC HALLERMAN: Well, the basic issue goes back to the problem of how the government first established oversight over genetically modified organisms.

PALCA: Eric Hallerman is a professor of fisheries and wildlife at Virginia Tech.

HALLERMAN: There is no particular act that establishes government authority to do it.

PALCA: Instead, in 1986, the Reagan White House decided to use existing laws - like the Federal Insecticide, Fungicide and Rodenticide Act; and the Food, Drug and Cosmetic Act - as the basis for regulating genetically modified organisms, something that has led to some strange circumstances. For example, for the purposes of regulation, the FDA considers a genetically modified mosquito 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.

HALLERMAN: I was thinking at that time that they were going to come out with some sort of a decision sometime that winter. Well, here we are at the next winter.

(SOUNDBITE OF SONG "THE WAITING")

PALCA: The point here isn't whether the AquaBounty salmon, or Oxitec's mosquito, really are safe. There are some legitimate scientific questions about that. The point is, the companies are in a regulatory never-never land. Ron Stotish is president of AquaBounty.

RON STOTISH: 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.

PALCA: 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 is the Democratic senator from Alaska. He's not convinced the salmon is safe, and approving it would threaten his state's wild salmon fisheries.

SENATOR MARK BEGICH: We don't need to go down this path, and I believe that that's a position we need to take.

PALCA: He's introduced legislation that would make it unlawful to ship, transport, offer for sale, sell or purchase genetically altered salmon or other marine fish. The White House has plans to overhaul its regulatory processes, but so far…

(SOUNDBITE OF SONG "THE WAITING")

PALCA: Joe Palca, NPR News.

(SOUNDBITE OF SONG “THE WAITING")

: ..you take it on faith, you take it to the heart. The waiting is the hardest part. Transcript provided by NPR, Copyright NPR.