The Food and Drug Administration (FDA) has announced plans to make “drastic” changes to the organization, hoping to improve the bureaucratic process a bit.
In a press release, the department stated, “The recommendations identified in the memorandum, when implemented, will drastically change FDA’s inspection and compliance processes. In particular, the plan will change the current region-based inspection and compliance system to a product-based system.” The FDA, which is an agency under the U.S. Department of Health and Human Services, is tasked with regulating food safety, tobacco, dietary supplements, prescription and over-the-counter drugs, as well as vaccines.
According to Commissioner Margaret Hamburg, there will be eight decisions that will “significantly change” the FDA’s inspection activities, all of which can be found here in detail.
Currently, FDA enforcement operations are organized by geographical regions. Operations vary by district, meaning some areas have investigators with a specialty based on commodity-type, while others have mostly “generalists,” which are people who cover a wider array of commodities. The changes will work toward organizing the FDA’s regulatory and compliance activities by commodity-type. Likewise, FDA employees in inspection and compliance roles will specialize in particular commodities.
Changes will also be made to the training process, with hopes to resolve “inadequate coordination” and “lack of prioritization” in its compliance policy and enforcement strategy process. Plans were mentioned to de-layer and “centralize” management as well as specialize FDA laboratories in order to optimize their productivity.
As in any large organization, the changes will probably be miniscule at first and will happen gradually, over a long period of time. “Although these changes will not have an immediate direct impact on regulated industry, they will result in significant changes to FDA’s inspections and compliance operations, potentially starting as early as the next fiscal year,” the press release states. “Over time, this will result in a marked change to inspections and enforcement actions.”
Last fall, Commissioner Hamburg released a memorandum with a similar outline, though the aim was to improve the FDA’s approach to the challenges “posed by globalization, scientific innovation, and the increasing breadth and complexity of the products it regulates.” The memo's bullet points of changes were somewhat similar to those listed in the newest announcement. It noted that the FDA would take steps required to develop plans that would “best achieve mission-critical Agency objectives.”