Regulatory Focus™ > News Articles > Legislators Ask FDA to Explain How it Missed Presence of Smallpox Vials for Decades

Legislators Ask FDA to Explain How it Missed Presence of Smallpox Vials for Decades

Posted 28 July 2014 | By Alexander Gaffney, RAC

Legislators Ask FDA to Explain How it Missed Presence of Smallpox Vials for Decades

The recent discovery of vials of smallpox and other potentially deadly pathogens at a facility controlled by the US Food and Drug Administration (FDA) raises "very serious questions" about federal regulators' capabilities and compliance with federal law, legislators said in a letter to FDA Commissioner Margaret Hamburg and other federal officials.

Background

FDA made headlines earlier this month when it announced that it had found vials of variola—the virus which causes smallpox—in a cold storage facility it controlled on the National Institutes of Health's (NIH) campus in Bethesda, MD.

The discovery was especially notable because the virus was officially thought to exist in only two places: at a laboratory controlled by the Centers for Disease Control and Prevention (CDC) in Georgia, and in a storage facility in Russia. Thanks to a worldwide effort, the disease has otherwise been eradicated from the human population since the 1980s.

A little more than a week later, FDA announced that it had found several hundred additional vials containing other potentially deadly pathogens, including samples of dengue, influenza, Q fever and rickettsia.

FDA only found the boxes which contained the vials during a clean-out of the room in anticipation of moving the Center for Biologics Evaluation and Research (CBER), which formerly resided at the facility, to FDA's new headquarters in Silver Spring, MD.

FDA said the vials had likely been in the facility since between 1946 and 1964, when CBER was still an office of the NIH.

Questions Emerge

But in the wake of the findings, legislators now have serious questions for FDA.

And atop their list is one seemingly simple question: How could the agency not have noticed the presence of these pathogens in its facility for almost half a century?

"The discovery of these select agents in a cold storage room raises very serious questions about the NIH's ability to control, secure and account for dangerous biological materials on the NIH campus and ensure compliance with federal select agent regulations," legislators wrote in a letter to Hamburg.

Legislators said they wanted information regarding the pedigree of the vials, which federal entity should have controlled the vials and whether the cold storage room where the vials were held had ever been inspected or audited.

Legislators noted that the agency's storage facility should have been inspected after a 2001 incident involving anthrax being sent through the US postal system—a sort of Catch-22 for the regulator. Either FDA failed to audit the facility or failed to catch the presence of the vials during the audit, calling into question the thoroughness of its audit.

FDA was given until 15 August 2014 to hand over the requested information, including emails related to the incident and previous audits.

 

Energy and Commerce Committee Letter to Hamburg

Other Letters to Federal Officials


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