Dr. Hamburg and Dr. Sharfstein confront FDA’s “Invisible Line”


New FDA Commissioner Dr. Margaret Hamburg and her top deputy Dr. Joshua Sharfstein have made an impressive start and have announced a new era of “effective enforcement” for the Agency. They have done some house cleaning at the top and headquarters bureaucrats are beginning to get the message. Many FDA enforcement actions originate from headquarters and effective actions can be taken. But the bulk of FDA enforcement actions come from the hard working FDA field investigators (CSOs- consumer safety officers), compliance staff, and laboratory scientists distributed throughout the country in FDA’s field organization, ORA- the Organization for Regulatory Affairs. The CSOs are the inspectional force who carry out the Agency’s mission to ensure safe food, drugs, medical devices, and blood products for the American people. They’re the ones conducting the inspections on a day-to-day basis. (full disclosure: I worked for ORA for 17 years) They are hampered by an obsolete inspectional system and poorly trained supervisors and middle managers. And there is an invisible line that separates them from Drs. Hamburg and Sharfstein.

ORA, The FDA field organization, is divided geographically into twenty District Offices each headed by a District Director. In addition there are 13 laboratories and over 150 “Resident Posts.” My last job at FDA was as a CSO at the Tacoma, WA Resident Post, a part of the Seattle District. In reality, few CSOs or other field personnel communicate with anyone higher that a District Director. They have few interactions with FDA headquarters personnel unless it is very directly related to their specific job function. The District Directors form the Invisible Line between the field force and the rest of FDA. They filter all communication between the two sections. And their word is law.

To make matters worse, CSOs have little communication with their counterparts in other districts. This means that if there is a New Drug Application (NDA) filed and headquarters issues Bioresearch Monitoring (BIMO) assignments for clinical trial inspections to the Denver, Dallas, Chicago, Atlanta, and Florida Districts there is almost no communication between the CSOs conducting the inspections. If a CSO issues a Form FDA 483, Inspectional Observations, in Chicago, it is highly unlikely that the information will be shared with colleagues in the other districts. There is no project management, no conference calls, no training on the therapeutic area, the protocol, issues of concern to the review division, There is nothing of the sort for BIMO.

A large part of the problem is a question of turf. ORA is supposed to conduct inspections, all inspections, whether they know how to do them or not. There are no requirements that a BIMO CSO knows how to read medical records. Many do and are excellent inspectors. Many don’t and the quality suffers. Time after time I am questioned about an FDA 483 and why it was issued. Many times I just don’t have an explanation. Of course, I don’t have the report and exhibits in front of me. But there is a lot of poor judgement being shown. Many FDA inspectors do not have the appropriate qualifications, receive adequate training, and understand the significance of their observations.

It starts with the management of the BIMO program at the district office. There is no requirement that a BIMO supervisor have any BIMO experience. It does not matter if they have ever conducted a BIMO inspection. One supervisor once told me that it wasn’t necessary that a CSO know how to read medical records. They were conducting the inspection for compliance with FDA regulations and the regulations were all that mattered. I asked how the CSO was supposed to locate adverse events that weren’t reported if they couldn’t read the medical records. All I received was a shrug of the shoulders.

Another supervisor, who was responsible for IRB inspections in five states, once asked me, “What’s the Belmont Report.” This is the basic bioethics document produced by the United States Government. You might know what it is (you can google it) but the person responsible for making IRB inspection assignments, reviewing reports, recommending promotions, assigning training, THAT person should know. If there is a poorly written FDA 483, it is the fault of the supervisor and other FDA managers for allowing it to continue. However FDA supervisors don’t do inspections. They sit behind a desk and figure out work plans. They are not in touch with what is happening in the field. They receive no technical training on the increasingly complex world of drug and device development. NONE. And that is one of the primary reasons that industry complains about inconsistent FDA inspections and inconsistent Form FDA 483 observations. It is a very big problem.

The majority of FDA field employees are very dedicated and outstanding. The country is very lucky to have them on the job. The majority of FDA field managers are not. Standing at the head of the field managers are the District Directors, the Invisible Line separating the FDA field from the excellent new leadership of FDA at headquarters. If Dr Hamburg and Dr. Sharfstein want effective enforcement of FDA regulations, then they are going to have to take a Hard Look at the Office of Regulatory Affairs.

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