The Center for Drug Evaluation and Research’s decision to move counter-terrorism and emergency coordination functions into the center director’s office reflects the cross-cutting aspects of the program and the importance of its work to CDER’s mission, FDA said.

Establishment of the Counter-Terrorism and Emergency Coordination Staff under the Office of the Center Director was one of three organizational changes announced in a Sept. 2 memo from CDER Deputy Director for Regulatory Programs Douglas Throckmorton. Other changes include activities related to drug shortages and external stakeholder engagement.

Throckmorton said the changes, which are effective immediately, will “improve work processes and collaborative partnerships within CDER, FDA and other federal agencies in all program areas.”

The moves are part of a larger reorganizational effort by CDER Director Janet Woodcock aimed at sharpening the center’s focus and strengthening its resources Also see "Generic Drugs Gain Status Boost Within CDER" - Pink Sheet, 7 September, 2012..

The initiative included elevation of the Office of Generic Drugs to a “super office” that reports directly to Woodcock and creation of a new Office of Pharmaceutical Quality, which has not yet been finalized Also see "Pharmaceutical Quality And Generic Drugs: Janet Woodcock Explains Her Vision" - Pink Sheet, 25 March, 2013..

Director’s Office Adds New Functions

CTECS provides scientific, regulatory and policy assistance for drug development initiatives relating to medical countermeasures and coordination of emergency activities involving CDER-regulated products.

The group’s responsibilities include: overseeing the Animal Model Qualification Program; liaising with other federal agencies; helping scientific researchers and drug sponsors early in medical countermeasure drug development prepare for formal regulatory meetings with CDER review divisions; providing policy expertise related to Emergency Use Authorizations; and facilitating consistent application of the “Animal Rule.”

CTECS’ functions previously had been in their own office within CDER – the Office of Counter-Terrorism and Emergency Coordination – but now will be housed in the Office of the Center Director.

FDA noted that CTECS works in collaboration with CDER’s Drug Shortages Staff (DSS), which also is now located in the Office of the Center Director. CTECS “assists in assuring the availability of vitally important drugs used to counteract or treat the effects of chemical, biological, radiological or nuclear threat agents – or public health emergencies such as pandemic influenza, natural and other disasters,” Throckmorton said.

In September 2012, FDA announced plans to move the drug shortages program from the Office of New Drugs into the Office of the Center Director, raising the organizational profile of the 11-member staff in the process Also see "FDA Drug Shortage Staff Gets Higher Profile As New Reporting Requirements Begin" - Pink Sheet, 28 September, 2012..

The move followed enactment of the FDA Safety and Innovation Act of 2012, which gave the agency new authorities to prevent and combat drug shortages and imposed new notification requirements on manufacturers aimed at heading off potential shortages.

“The elevated placement for DSS – with its greater visibility and prominence within the center – reflects how important the work of the DSS is to ensuring that patients in need have critical and life-saving drugs available to them,” Throckmorton’s memo states. “Undoubtedly, this work is paramount to the center’s mission to guarantee that safe, effective and high-quality drugs are available to the American public.”

“In order to more successfully adapt to growing challenges, the alignment of the Drug Shortages Staff and the Counter-Terrorism and Emergency Coordination Staff under the Office of the Center Director will allow us greater ability to meet these challenges,” FDA said in response to questions.

More Than Just Safe Use

The third change highlighted in Throckmorton’s memo is the retitling of the Safe Use Staff in the Office of the Center Director. The group will now be known as the Professional Affairs and Stakeholder Engagement Staff to reflect its expanded functions.

Professional Affairs and Stakeholder Engagement Teams

Safe Use Team – Collaborates, plans and manages non-regulatory initiatives to make significant improvements in the safe use of medications and reduce preventable harm from medication misuse, abuse and errors.
Engagement Team – Provides systematic and coordinated engagement with stakeholders to develop complementary, collaborative actions that will improve medication use and increase awareness of regulatory activities. This includes meeting with and responding to advocacy groups and professional organizations about drug development, drug review and drug safety.
Education Team – Develops research-based tools to inform and educate health care professionals and advocacy groups on issues that relate to regulatory activities of CDER.

The agency previously signaled the new nomenclature in November 2013 when it announced John Whyte as director of professional affairs and stakeholder engagement Also see "CDER Outreach Coordinator’s First Task Is Safe Use Initiative" - Pink Sheet, 7 November, 2013..

Whyte was tapped to oversee the Safe Use initiative, a public/private collaboration aimed at reducing harm caused by medical errors, unintentional drug exposures, and misuse and abuse of drugs. However, he also was hired to work with health care providers, patient groups and other stakeholders, serving as a focal point for advocacy, communication and collaboration on drug development and drug safety issues.

Throckmorton said PASES “will enhance the effectiveness of stakeholder engagement and advocacy efforts through clear priorities and strategic alliances.”

“In addition, PASES will conduct research to ensure CDER has a thorough understanding of partner, stakeholder and public opinion. It will also use expertise on particular internal and external initiatives of interest to CDER by soliciting stakeholders to obtain cooperation and collaboration through identification of common issues.”

Furthermore, “PASES will be responsible for developing and implementing the overall operational plan for stakeholder engagement and advocacy to achieve the operational and strategic goals of the center,” Throckmorton said.

FDA said PASES represents the creation of a new staff, with Safe Use being one of three “teams” (see box). While the Safe Use program had seven staff, PASES has a total of 18 full-time equivalent positions.

No FTEs are being lost through the reorganization and leadership of the Drug Shortages Staff, CTECS and PASES have not changed. All staff report to Throckmorton.

CDER’s Counter-Terrorism, Emergency Coordination Operations Get New Home

More from Asia

More from Geography