Congressmen Question FDA Over Office of Laboratory Safety

Regulatory News | 19 May 2016 | By Zachary Brennan

Rep. Fred Upton (R-MI), chairman of the House Energy & Commerce Committee, and Rep. Tim Murphy (R-PA) sent a letter to US Food and Drug Administration (FDA) Commissioner Robert Califf on Wednesday questioning why the agency has not formulated a budget request or level of staffing for its Office of Laboratory Safety.

The letter follows an April hearing at which FDA said it has taken “direct and definitive actions” to improve lab safety. That hearing came as a report from the Government Accountability Office found an FDA researcher in 2014 overlooked boxes of lab samples, some of which contained the virus that causes smallpox.

In addition to taking issue with FDA’s lack of funding plans, Upton and Murphy said the agency’s reporting structure is not appropriate as the director of FDA’s Office of Laboratory Safety currently reports to Califf through the Office of Chief Scientist.

“Given the critical importance of this mission and to ensure the safety of the FDA’s laboratory scientists and securing hazardous biological agents and toxins, the funding associated with the operations of these offices [at CDC, FDA and NIH] and associated programs should come from a direct source and not through competing resources with other agency missions and priorities,” the letter reads.

The congressmen do note that in a briefing with committee staff, FDA envisions 13 full-time staff for its Office of Laboratory Safety.

By 1 June, the congressmen request information from FDA on:

• The level of funding and staffing for its Office of Laboratory Science and Safety for the next fiscal year;
• Whether FDA will commit to independent funding for its office;
• Whether the office director will report directly to Califf;
• Whether FDA will offer an internal report on the unaccountable smallpox vials; and
• Whether FDA will issue written procedures for transporting and securing “select agent materials on-site at FDA or between FDA laboratories.”

Letter