FDA Office of Regulatory Affairs Realignment to Begin in May

Shuren made the announcement to members of the House Energy & Commerce Committee on Tuesday at a hearing on the Medical Device User Fee Amendments, which must be reauthorized by 30 September of this year or the program will lapse, forcing FDA to initiate massive layoffs.  “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.

FDA spokesperson Lyndsay Meyer confirmed to Focus that the long-planned program alignment for ORA will kick off on 15 May 2017, saying the office “will be moving away from a geographic (regional) management model and align with a commodity-based program structure.  All Regional Food and Drug Directors (RFDDs), Regional Directors and Regional staff will transition into other positions in ORA.”

As of 17 May, Meyer says that FDA will sunset it’s five regional offices, replacing them with six commodity-focused divisions for drugs, biologics, medical devices, bioresearch monitoring, food and tobacco.  Meyer also told Focus that the agency will maintain its 20 existing districts, with district directors gaining program specific responsibilities.  Meyer also noted that the agency would not be closing any offices, and no employees will lose their jobs or be asked to move as a result of realignment.

During the hearing Shuren fielded questions from Reps. Larry Bucshon (R-IN) and Markwayne Mullin (R-OK) on some of industry’s pain points for device inspections, saying that program alignment could help ease some concerns.  Mullin said that “companies are concerned about the lack of transparency, predictability, efficiency and consistency” of FDA’s device inspections, adding that he’s heard foreign device inspections are often more efficient than domestic ones.

“It is true that domestic inspections may take longer than foreign inspections.  For foreign inspections they’re making arrangements for that Investigator to go over for that inspection, so that’s all they’re there for, [then] they come back.  On the domestic side, that Investigator 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 said.  However, Shuren said that many of those issues will be addressed by program alignment at ORA.  “As part of this program alignment effort [ORA] is revisiting its [standard operating procedures] SOPs so that it reduces the time for domestic inspections,” he said, adding that once fully implemented inspectors will have more training and expertise in their particular product area.

However, Shuren noted that it could take two or three years before all the changes are in place.

REFERENCE:  RAPS; 28 MAR 2017; Michael Mezher

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