Using the argument that the acceleration of scientific innovation and expansion of global markets require it, the Food and Drug Administration (FDA) is seeking new program models to meet the demands of a changing world. According to FDA, these needs led to the recent realignment of FDA’s inspection, investigation, laboratory and import/export functions, which historically were by the Office of Regulatory Affairs (ORA) as a sister organization to FDA’s product/policy Centers. Below we will describe what FDA did and why it matters to the industry. At the outset, we will state our bias: this realignment will result in a significant break between the trade and the agency creating additional middle management layers in the field and between the decision makers and the firms affected by those decisions. It also represents a stove-piping and consolidation mentality, which is typical of aging bureaucracies sensing the need to rearrange the deck chairs to make it look like it is keeping up with the latest. Whereas industry has been able to rely on relationships with local FDA officials near them geographically, now significant policy, procedure and enforcement decisions will more often be made by FDA officials across the country hidden behind a shroud of expertise, answering machines and email auto-responders. This will not be better for FDA or the trade. FDA cites as benefits facilitation of cooperation between staff doing complementary work in a particular product area and optimizing coordination, strengthening accountability, and reducing duplication. The missing element, of course, is FDA’s mission, which at least in part involves ensuring that safe products make it to and stay on the market for the benefit of consumers.
What is the New Model?
The new organizational model is about specialization in management structure and in the utilization of the workforce. Historically, the Agency has been organized around five regional offices in which employees often worked in a variety of areas regardless of their personal expertise. However, those five regional offices have morphed into seven products or operations-aligned offices where the staff will specialize in a particular product or commodity.
- Office of Bioresearch Monitoring Operations (OBIMO)
- Office of Biological Products Operations (OBPO)
- Office of Medical Device and Radiological Health Operations (OMDRHO
- Office of Pharmaceutical Quality Operations (OPQO)
- Office of Human and Animal Food Operations (OHAFO)
- Office of Enforcement and Import Operations (OEIO)
- Tobacco Operations Program (TOP)
This coordination will extend to the reporting chain for ORA’s inspection and compliance in the hope of optimizing technical expertise and fostering a more uniform application of ORA’s policies and procedures.
What will be the Impact on Industry?
- The Agency will look more globally at imports.
- Generally, after the reorganization, each new Division will now receive cargo from more foreign ports than any of the old districts did (except). This will create some strain on the import process, as the compliance and supervisory chains will cross over into work with which FDA personnel will lack direct experience. FDA is more likely to see things on a national scale now that were overlooked before.
Although FDA has been progressing toward internal cross-walking programs to refer imports of concern across districts, dropping from 21 districts to 5 divisions will advance that effort. Certainly, where one port discovers a problem with a product from a specific supplier it can easily add electronic screening criteria to affect all the activities of all ports within the Division. Because the divisions cover significantly more ports than any one District did (with the exception, perhaps, of the Southwest Import District) the agency will be significantly more coordinated than prior to the re-organization.
- The reorganization is likely to help Customs and Border Patrol (CBP) get even tougher with enforcement.
FDAImports.com is here to answer your questions on how this realignment will affect you and your business. Contact us today for more information.
