FDA's Program Alignment To Make Inspections More Efficient

By Jof Enriquez,
Follow me on Twitter @jofenriq

The U.S. Food and Drug Administration's Office of Regulatory Affairs (ORA) will start implementing on May 15 its program alignment, which will shift FDA personnel from geography-based to commodity-based teams and make inspections more efficient.

Former FDA Commissioner Margaret Hamburg in 2013 formed a Program Alignment Group (PAG) tasked with modifying FDA’s functions, processes, and structure in order to meet the challenges posed by scientific innovation, globalization, and the increasing breadth and complexity of the products that the agency regulates. FDA's Directorates, Centers, and the ORA then drafted detailed individual action plans to realize their goals in the next five years.

During a user fee authorization hearing held this week, Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren told members of the House Energy & Commerce Committee that FDA is ready to formally start the change management initiative in the coming weeks.

"As a part of the program alignment effort — which is getting officially stood up in the coming weeks — [ORA] is looking to revisit their standard operating procedures and other processes to make device inspections more efficient, more timely and to have the right kind of engagement back with the companies," Shuren said, according to RAPS Regulatory Focus.

Shuren responded to committee members’ questions, which echoed concerns from companies that domestic inspections performed by FDA were neither as transparent nor as efficient as foreign device inspections, and he told lawmakers that the program alignment will address those issues.

"It is true that domestic inspections may take longer than foreign inspections. For foreign inspections they're making arrangements for that inspector to go over for that inspection, so that's all they're there for, [then] they come back. On the domestic side, that inspector may be finishing up with another inspection, or they get called away for a for cause inspection. That said, on average, most domestic and foreign inspections occur in four days or less, sometimes within one day," Shuren reportedly said.

FDA spokesperson Lyndsay Meyer told Focus that the program will launch on May 15, and that by May 17, FDA "will sunset its five regional offices, replacing them with six commodity-focused divisions for drugs, biologics, medical devices, bioresearch monitoring, food and tobacco."

However, the agency will keep its 20 existing districts and no layoffs are expected. District directors will be assigned program-specific responsibilities, while regional food and drug directors (RFDDs), regional directors, and regional staff will transition into other positions in ORA, according to Meyer.

As inspectors get used to revamped standard operating procedures and acquire more training and expertise in a particular product area, FDA anticipates domestic inspections to be completed more quickly.