Heparin Crisis Spurs Changes In FDA Emergency Response Policies

Internal and external evaluations of FDA's handling of the heparin contamination crisis of early 2008 have led to changes in the agency's emergency response strategy and a new policy on emergency collaborations with outside experts.

In September 2010, the agency finalized its Emergency Operations Plan addressing difficulties encountered during the heparin crisis, including a lack of specificity on leadership and coordination of the response in the previous Emergency Response Plan.

FDA also instituted a policy in October requiring staff to consider and protect against risks posed by collaborations with outside experts in emergency situations.

The Government Accountability Office discusses the two documents in a Nov. 9 review of FDA's response to the adulterated heparin products that generated hundreds of adverse event reports in 2008 and prompted increased scrutiny of supply chain operations for sectors across the food and drug industries (Also see "Heparin Fallout Likely To Impact Supplement Ingredient Testing Exemptions" - Pink Sheet, 7 Apr, 2008.).

House Energy and Commerce Committee ranking member Joe Barton requested the report. The Texas Republican is making a bid for committee chairman following the GOP takeover of the House in the Nov. 2 elections (Also see "Barton Attracts Support In Uphill Bid For Energy and Commerce Chair" - Pink Sheet, 15 Nov, 2010.).

GAO's final report reviews various elements of FDA's response, including efforts to avoid a domestic heparin shortage during a recall of contaminated products and increased inspectional oversight of Chinese firms involved in heparin production. The report also reflects how FDA has adapted its emergency response procedures as a result of the heparin incident.

"Lessons Learned" Review

The report recaps the agency's internal evaluation of lessons learned in responding to the crisis.

FDA's heparin response actions were coordinated under the ERP in place since 2005. Although the Office of Crisis Management initially coordinated the response across numerous FDA centers and offices, the Center for Drug Evaluation and Research took over the role of lead coordinator once it was determined that the adverse events were related to the heparin drug product.

OCM participated in heparin task force meetings convened by CDER but had no role in the ongoing coordination of response efforts.

Documents from "lessons learned" meetings conducted following the crisis show a lack of detail in the ERP and absence of agency-level coordination may have caused process delays and difficulties with internal and external communication, GAO says.

Since the ERP did not specify who should coordinate the agency's response, whether OCM or CDER should assume this role was unclear. When leadership transitioned from OCM to CDER, center officials spent time determining roles.

In addition, Center for Devices and Radiological Health officials said issues related to heparin-containing medical devices often were not addressed in CDER's communications.

FDA began developing a new emergency response plan, the EOP, in October 2008. The now-finalized EOP, which replaces the ERP, contains a section on coordination at the agency level within FDA's headquarters and offers guidance and a coordination structure that can be used during an incident.

The plan calls for the designation of an Agency Incident Coordinator to manage an event at the agency level and serve as a communications bridge between the commissioner's office and the agency's centers and offices.

An Agency Executive Group, comprising senior FDA officials, will be convened to provide strategic policy direction and guidance for major response activities.

By Sue Sutter