Using Regulations to Neutralize Red Tape

One of the principal responsibilities of the U.S. Food and Drug Administration (FDA) is to keep the public safe from untested medical devices and medications. The FDA does this by, among other things, requiring rigorous testing to prove the efficacy and safety of those devices and medications; this important process sometimes takes years to complete, though, and there are some situations when such an extended period of time is simply not available.

When the nation is faced, for example, with an imminent disaster, such as a rapidly spreading disease of unknown origin, the last thing the public will accept is a “cure” being withheld because of what is often described (inaccurately) as “bureaucratic red tape.” This is the basic concept behind what is called the Emergency Use Authorization (EUA) rule.

The EUA rule can be used to cope with a specific threat from a specific agent – biological, chemical, radiological, or nuclear. The threat need not evolve into reality for the EUA order to be issued, because the rule postulates that an order can be issued if there is a significant potential of a lethal threat becoming a reality.

The determination that a threat or future threat from a specific agent rises to the level needed for use of the EUA rule is made by the secretary of any one of three major federal departments: Defense (DOD); Health and Human Services (HHS), or Homeland Security (DHS).

The goal of the EUA rule is to save lives during a national crisis by allowing the use of a product that has not yet received final FDA approval. There are two important conditions attached, though: the known and potential benefits of the product must, insofar as can be determined, outweigh the known risks; and there must be no approved alternative already available. In addition, the FDA commissioner must establish the essential criteria and circumstances under which the new product can be used.

Because the EUA ruling is made only in response to a life-threatening emergency, the decision to allow the use of a product that has not yet received final FDA approval is obviously not without risk. That risk is covered by the Public Readiness and Emergency Preparedness Act of 2005, which covers care providers as long as they follow the recommended-use guidelines provided by the FDA.

A Timely Example: N-95 & the WHO-Declared Pandemic 

The threat posed by the 2009 H1N1 strain of influenza provides a useful example of how the rule can be implemented. The H1N1 strain threatened in its early stages to be the next deadly strain of influenza and was, in fact, declared by the World Health Organization to be a “global pandemic.” Fortunately, the U.S. public health and medical communities had been preparing for a number of years to meet such a challenge – when (but not if) it became a reality.

One of the most effective weapons used to contain the H1N1 virus was a new face mask, the N-95 respirator, which had not yet received final approval from the FDA. An N-95 respirator is able to filter out very small particles – including particles on the scale of many viruses. It has been authorized, under the EUA rule, for use in medical and emergency services settings to prevent staff-to-patient and patient-to-patient transmission of respiratory-borne diseases.

Section I of the FDA’s letter of authorization spelled out the entire justification for the EUA: 1. the H1N1 2009 virus is potentially life threatening; 2. the totality of available evidence indicates that the potential benefits of using an N-95 mask outweigh the risks; and 3. there is no available and fully authorized alternative.

The FDA used that rationale, as spelled out by law, to authorize the distribution of N-95 respirators, with accompanying fact sheets, to the healthcare community and the general public; included in the EUA rule was information about possible distribution from the supply of N-95 masks stored in the Strategic National Stockpile.

Use of the EUA meets the needs and expectations of the general public, while at the same time respecting and maintaining the rule of law. The latter may seem to some to be a relatively small consideration when the nation is staring into the abyss. However, there is always a day of reckoning, and those who act in good faith to protect their fellow citizens should be protected by that same rule of law – whether their decisions affect, and protect, the nation as a whole, or just the individual patient.