Committee Leaders Expand Investigation of Recent Safety Lapses Involving Anthrax, Smallpox, and Avian Influenza

Committee Leaders Expand Investigation of Recent Safety Lapses Involving Anthrax, Smallpox, and Avian Influenza

The following press release was published by the House Committee on Energy and Commerce on July 28, 2014. It is reproduced in full below.

WASHINGTON, DC - House Energy and Commerce Committee leaders today continued their investigation of recent safety lapses involving dangerous biological materials known as select agents, including anthrax, smallpox, and avian influenza. Committee leaders today sent letters to the Centers for Disease Control and Prevention, the Food and Drug Administration, the National Institutes of Health, and the Health and Human Services Inspector General seeking further information about the recent incidents and federal management of select agents. The Subcommittee on Oversight and Investigations recently held a hearing on these lapses where CDC Director Tom Frieden testified.

“An ‘insufficient culture of safety ’ at the agency charged with dealing with the most dangerous pathogens known to man is beyond belief and wholly unacceptable," commented full committee Chairman Fred Upton (R-MI) and Oversight and Investigations Subcommittee Tim Murphy (R-PA). “These recent safety lapses raise a number of questions and concerns regarding how federal agencies are responding to these incidents, what actions have been taken in the past, and does Congress need to intervene. Ziploc bags somehow become an acceptable means to handle anthrax and who knows what other deadly agents - those days are over."

In a letter to Frieden, the leaders note that the steps Frieden outlined in response to these most recent events are very similar to steps he said CDC would take following a 2012 incident. The leaders ask CDC if those steps were not taken in 2012 and, if they were, if they were ineffective. Further, the leaders ask, “Since part of CDC’s epidemiology work is detecting or recognizing patterns of disease outbreaks, how could CDC not recognize the pattern of select agent incidents that was recognized by the OIG in 2010?"

In letters to FDA Commissioner Margaret Hamburg and NIH Director Francis Collins, the leaders ask about smallpox vials recently discovered in an FDA lab on the NIH campus. The letters note, “In addition to the smallpox vials, the FDA disclosed last week that the FDA workers also found 12 boxes and 327 vials holding an array of other pathogens, such as dengue, spotted fever, influenza, and Q fever. 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."

In a letter to HHS Inspector General Daniel Levinson, the leaders request copies of any HHG OIG audits of Building 29A, formerly NIH and presently FDA, conducted since 1980.

The letter to NIH also asks for further information about the National Science Advisory Board for Biosecurity (NSABB). “We note that this advisory panel has not been convened in nearly two years, that the Board’s charter was changed in March so that the Board no longer has responsibility to review research that might be repurposed for bioterrorism or bioweapons, and that 11 of the 23 panel members were suddenly dismissed by NIH official and executive director of the NSABB, Mary Groesch, on a Sunday evening (July 13, 2014). These circumstances raise serious questions about the rationale and motives behind the dismissals of the panel members and the change in the Board’s charter."

The letters were signed by Upton, Murphy, Chairman Emeritus Joe Barton (R-TX), full committee Vice Chairman Marsha Blackburn (R-TN), and Vice Chairman of the Oversight and Investigations and Health Subcommittees Michael C. Burgess, M.D. (R-TX).

Source: House Committee on Energy and Commerce