Regulators’ Infectious Zika Incompetence

The bad news about Zika continues. The epidemic that has spread from Brazil to the rest of Latin America is now raging in Puerto Rico, with thousands of residents infected every day, and the first locally transmitted cases have been reported in the United States — more than a dozen during the past week or so in south Florida. Although the number of known locally transmitted cases is still small in this country, the fact that there are any at all is ominous (if not unexpected): It reflects that there are sufficiently large numbers of people with circulating Zika virus that mosquitoes are finding and biting them and then passing the virus along to another person or persons. We’re certain to see increasing — possibly exponentially increasing — numbers of cases.

Zika causes babies to be born with small heads and malformed brains, and probably other, more subtle defects. It also causes some adults to suffer the progressive paralysis of Guillain-Barré syndrome. Several companies are working on a vaccine, but because of technical issues and regulatory requirements, none is likely to become commercially available before the end of the decade.

Congress and the Obama administration have been at odds about how much additional funding is necessary to respond to the Zika outbreak, but far more significant is the bumbling of Obama’s Food and Drug Administration, which is blocking progress on a vital tool to control Aedes aegypti mosquitoes, which carry and transmit not only Zika but also the viruses that cause dengue fever, chikungunya, and yellow fever.

Using molecular genetic-engineering techniques, the British company Oxitec (a subsidiary of America-based Intrexon) has created male Aedes aegypti mosquitoes with a mutation that makes them need a certain chemical (the antibiotic tetracycline) to survive. Without it, they die — as do their offspring — before reaching maturity. If these males are fed a diet containing tetracycline (to keep them alive long enough to reproduce) and then released into the wild over several months, the result is a marked reduction in the mosquito population. Because male mosquitoes don’t bite, they present no health risk, and, because their progeny die before they can reproduce, no genetically engineered mosquitoes persist in the environment.

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This approach has already been widely and successfully tested abroad. Efficacy trials of Oxitec’s genetically engineered mosquitoes across Brazil, Panama, and the Cayman Islands all resulted in greater than 90 percent suppression of the wild population of Aedes aegypti mosquitoes, and the World Health Organization has endorsed Oxitec’s product. (Aedes aegypti mosquitoes are an invasive species in the Americas, so there’s no possibility that reducing their numbers will disrupt natural ecosystems.)

But U.S. regulators have been paralyzed, unwilling to permit even small-scale field testing. The story behind this monumental snafu has several elements, all of which were avoidable.

#share#The first problem is that the FDA and the Agriculture Department are completely out of sync. The Oxitec mosquito should be regulated by the USDA’s Animal and Plant Health Inspection Service, which has the authority and expertise to oversee field trials and commercialization of genetically engineered insects. (The technique of using sterile insects to control pest populations was developed in the 1940s by the USDA’s E. F. Knipling, who used irradiated males to eradicate the New World screwworm, an evil-looking parasite that attacks livestock and humans, from the U.S. and much of North America.) But for a combination of reasons, including budgetary concerns and antagonism to genetic engineering among some senior USDA officials, the department demurred. It ceded jurisdiction to the FDA, which is completely unqualified to review the mosquito and unwilling to move its approval along.

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The FDA regulates the genetic material introduced into the mosquito as a “new animal drug” — similar to the way it regulates flea medicines and analgesics for dogs and cats. The rationale is that introducing DNA into the genome of the mosquitoes is analogous to dosing them with a drug. (This was an unwise and unnecessary policy decision, but that is a story for another day.) According to statute, in order to be marketed, the genetic material, like other “drugs,” must be shown to be safe and effective for the animal.

That presents a problem, because to approve the Oxitec insect, the FDA would need to employ logic that only a regulator could love: Regulators would somehow have to conclude that the genetic material that causes a male mosquito to self-destruct after producing defective offspring is safe and effective for the mosquito. The FDA could find itself tied up in legal knots if its ultimate approval of the insect were to be challenged in court by environmentalists or anti-genetic-engineering activists.

The FDA regulates the mosquito’s genetic modification as a ‘new animal drug’ — similar to the way it regulates flea medicines and analgesics for dogs and cats.

Nevertheless, in 2011 the FDA, apparently whistling past the graveyard, accepted Oxitec’s application to perform a field trial in the Florida Keys. But because of timidity, incompetence, or under-the-radar political considerations, not a single test mosquito has yet been released. In May of last year, the FDA announced that a proposed environmental assessment of the trial would be issued, and a draft, which concluded there would be “no significant impact,” was finally released this March. It went out for public comment, after which the FDA will analyze the comments and decide whether to issue a final assessment or prepare a complete environmental-impact statement — which could take years.

Given the impending threat of widespread Zika infections, and their sequelae, in the United States, the FDA’s performance — or lack of it — is outrageous.

For the USDA’s part, in 2011 its Office of Inspector General issued a report highly critical of the department’s oversight of research on genetically engineered animals and insects. It concluded that there had been no progress since 2007, when a new Animal Policy Branch was established in an effort to delineate regulatory authority for genetically engineered animals. The department responded to the report by committing to develop a regulatory framework by the end of 2011. We’re still waiting.

American innovation and public health are poorly served by our government’s negativism toward a variety of innovative technologies that can help to control the mosquitoes that not only transmit viruses but also are the vectors for devastating parasitic diseases like malaria. The incentives to pursue these revolutionary technologies will evaporate, as others have, in the face of insuperable, unwarranted regulatory obstacles.

#related#The Obama administration continues to cavil that Congress has not yet appropriated all the additional funds the president has requested, but the real obstacles to progress are in the executive branch’s regulatory agencies. There is congressional culpability, too, in not holding hearings to demand explanations for regulators’ egregious failures.

With the Zika threat becoming more ominous, the president’s failure to take immediate action to unravel his agencies’ regulatory tangle is irresponsible. He should direct the Agriculture Department to accept jurisdiction over the Oxitec field trial and subsequent tests of insect biocontrol agents (genetically engineered or not), and to expedite their review. What we’ve seen up to now from the Obama administration is an affront to public-health administration and an unnecessary threat to Americans.

— Henry I. Miller, a physician and molecular biologist, was the founding director of the FDA’s Office of Biotechnology and is now a fellow at Stanford University’s Hoover Institution. John J. Cohrssen was formerly a counsel to the White House Biotechnology Working Group, an associate director of the President’s Council on Competitiveness, and a counsel for the House Energy and Commerce Committee.