The U.S. Food and Drug Administration regulates $417 billion worth of domestic food products and an additional $49 billion worth of important foods. Though the FDA is primarily associated with the food industry, it certainly is essential for drug regulations and even worldwide safety.
In an attempt to fight back against bioterrorism, the FDA has recently approved a new drug meant to treat smallpox.
According to Time, the FDA announced in mid-July that they approved the first drug specifically designed to treat smallpox. Though the daily threat of smallpox is essentially nonexistent, since the disease was officially eradicated in 1980, terrorists are still able to deploy similar pathogens and cause potentially fatal health concerns.
The smallpox disease can kill nearly a third of people who get it and is even more lethal to infants. Unfortunately, a simple vaccine for smallpox isn’t feasible, either, because it is in itself too dangerous.
“To address the risk of bioterrorism, Congress has taken steps to enable the development and approval of countermeasures to thwart pathogens that could be employed as weapons,” said FDA Commissioner Scott Gottlieb. “Today’s approval provides an important milestone in these efforts. This new treatment affords us an additional option should smallpox ever be used as a bioweapon.”
The drug is called TPOXX (or tecovirimat) and was tested on animals with viruses closely resembling smallpox. The tests complied with the FDA’s Animal Rule, which decrees that well-designed animal studies can be used in place of human experiments when it wound not be ethical or safe to test a product on people. However, 360 humans did volunteer to have the new drug tested on them.
The FDA approval of the drug went to Siga Technologies of Corvallis Ore., a private company that developed the medicine under a federal biomedical defense contract. Results of drug testing by Siga Technologies were published in the New England Journal of Medicine.