When I was an FDA official, the agency’s lawyers laid down a basic principle: “When public health is at stake, do what you need to, and we’ll find a legal justification. We have plenty of legal tools.” I found that to be true. For example, in order to get a dangerous product withdrawn from commerce quickly, there is the “imminent hazard” provision in the FDA’s regulations that may be invoked when a product or practice poses “a significant threat of danger to health” that “should be corrected immediately to prevent injury.”
Conversely, the FDA can authorize the emergency use of an unapproved product in a situation that poses a public-health emergency, such as an emerging disease, for example a new strain of pandemic influenza. There is a detailed protocol to follow for the FDA to issue an Emergency Use Authorization of Medical Products, which begins with the secretary of HHS (or of defense or of homeland security) declaring that a significant health emergency exists.
Does the Zika outbreak qualify? There is a good argument that it does. There have been more than 16,000 cases of Zika infection in U.S. territories (most in Puerto Rico) and scores of locally acquired cases in Florida. The number of locally transmitted cases is continuing to increase, as are the known modes of transmission. Zika infection is known to cause severe birth defects early in pregnancy and subtler ones later. It can also cause a progressive paralysis called Guillain-Barré syndrome. At the direction of the governor, Florida’s surgeon general has declared a public-health emergency for 29 counties in the state.