Regulatory Focus™ > News Articles > US Bioterrorism Countermeasures Run in to Regulatory, Ethical Hurdles

US Bioterrorism Countermeasures Run in to Regulatory, Ethical Hurdles

Posted 03 January 2012 | By Alexander Gaffney, RAC 

The United States has been working to develop countermeasures to potential biological terror attacks on U.S. soil and abroad.  In response to the anthrax attacks of 2001 and later simulations by the National Security Council and Johns Hopkins University that estimated that a coordinated smallpox attack could kill up to one million U.S. citizens, the Department of Defense started the Transformational Medical Technologies Initiative in 2006 to develop what it refers to as "medical countermeasures" to combat the potential threat.

But as The Scientist writer Fran Hawthorne notes, "there's a catch: the Pentagon has no way to determine whether these countermeasures actually work."

The program is running in to ethical hurdles when it comes to testing the countermeasures. While the products can undergo pre-clinical testing and Phase 1 clinical trials in healthy human beings, the drugs cannot be tested on "sick" volunteers. Because the viruses and toxins are rarely-if ever-found in the native population, this would require administering a potentially deadly or debilitating toxin or virus to an otherwise healthy volunteer.

The US Food and Drug Administration initially formulated the Animal Efficacy Rule ('The Animal Rule') in May of 2002 that allowed products that could not be ethically tested on human beings to still be brought to market if animal testing models proven satisfactory. However, there are still significant doubts that a product approved via this approval pathway will actually be effective.

But now some companies are looking to run an end-game around the process, opting instead to develop treatments with broad applications.

The hope is that by proving a product's safety in a class of diseases and viruses, a company can convince the FDA-and the DOD-that a product is safe and effective, even without going through a clinical trials process for that particular indication.

(The Scientist - "Bioterrorist Battles - A Swiss-based firm may have a back-door way to thwart a bioterrorist attack-by fighting the flu.")

(BiocenturyTV- "Bioterrorism: Are We Safe? Biodefense 10 Years After 9/11"

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