FDA's Old Guard Fades Away in Enforcement Shakeup
in Regulatory and Compliance
by Chris Wiltz on October 11, 2013
Two announcements by commissioner Margaret Hamburg are creating internal dissent at FDA as inexperienced staff are being placed in field enforcement leadership positions over field veterans.
By Jim Dickinson
Should FDA’s cops be led by veterans with actual experience in the trenches or doesn’t that matter anymore? It’s a question that has arisen across government as political oversight and user fee leverage have combined to make agencies like FDA more responsive to the industries they regulate.
At FDA, the question is provoking internal dissent in the wake of two mid-September announcements by commissioner Margaret Hamburg that bring both the operational structure and the leadership of the agency’s sprawling field enforcement organization known as the Office of Regional Affairs (ORA) into question.
The issue is whether this reorganization, or “program alignment” in the newspeak of Hamburg’s announcement, will transfer the control of inspections and the negotiations they cause away from the field veterans, who have been remote and relatively independent of user-fee program commitments, to headquarters FDA officials who are closely engaged with user-fee commitments, not to mention their monitors in industry and on Capitol Hill.
It’s not a choice anyone is supposed to make. Would you rather have a user fee-compromised inspection of your plant, or an honest and objective one?
According to her announcement, Hamburg has formed an internal Program Alignment Group (PAG) made up of senior agency staff ─ the six program center directors, associate commissioner for regulatory affairs (ACRA) Melinda Plaisier
, her acting deputy Steven Solomon, and acting deputy commissioner for Global Regulatory Operations and Policy John Taylor III.
Unmentioned in the announcement is that none of these people has any boots-on-the-ground experience in the organization they’re about to carve up: ORA. Also unmentioned is the checks-and-balances basis for keeping an arm’s length distance between the management of product reviews and the management of inspections: The former’s purpose is to get the product to market as fast as possible, while the latter’s is to verify that the quality and product integrity promises made in the marketing submission are still valid.
In an email to staff, Hamburg explained the rationale for PAG: “Over the past few years, FDA has experienced unparalleled challenges and demands posed by the increasing breadth, depth, and complexity of the products it regulates
. That, combined with significant strides in scientific innovation and increased biomedical discovery, the globalization of the food system and medical supply chains, as well as the expansion in FDA’s regulatory authorities via many new forms of legislation, requires the agency to continue to find ways to ensure that we are meeting our critical public health and regulatory mission.”
To outsiders that may all sound well and good, but to FDA employees in the hundreds of far-flung field offices around the country it looked like a wolf in sheep’s clothing ─ a thinly disguised rerun of numerous prior attempts by the various product-reviewing program centers to have field employees assigned directly to the centers. Each prior attempt was acrimoniously rebuffed.
A colleague and 38-year FDA field veteran, former Denver District director John Scharmann, conferred with a few of his former ORA field peers about Hamburg’s announcement and reports a consensus that her rationale doesn’t make much sense.
ORA, he says, successfully absorbed far bigger challenges in prior additions of new authority, including the Drug Abuse Amendment of 1964 which resulted in a new bureau within FDA and ultimately the Office of Criminal Investigations, the addition of product safety legislation and the addition of the biologics obligation that eventually led to today’s Center for Biologics Evaluation and Research.
“To most, the ORA field is not only the eyes and ears of FDA, it is also the face as that is the contact point for most people,” Scharmann says. “The folks occupying the ACRA’s office in recent years are what I will call CARCAs ─ Caretaker ACRAs ─ having presided over a loss of authority in that office and the diminishment of ORA’s status within FDA.”
ORA’s traditions and culture began in a time when its operations were unquestionably funded by Congress, when user fees lay far in the inconceivable future. For the ORA “Old Guard” that’s still the way it is.
Scharmann and his peers from the past wonder how today’s Washington Beltway-centric FDA program centers, dependent on user fees, will be able to manage ORA’s districts and resident posts. “Will each center have to establish a controlling office similar to the ORA?” he asks. “How will this help deal with the management layering that is identified in the PAG memo as a problem?”
He also wonders how the centers will be able to assess the quality of field employee work, and who will coordinate resources in the event of a national emergency ─ “How long will this take when time is of the essence? Currently ORA and the ACRA can handle this with a phone call without the need for a group meeting.”
For regulated industry, some of these concerns may seem small potatoes. But the skill and experience of the people who manage the conduct of FDA inspections and their repercussions is far from small potatoes.
Ask Utah Medical Products CEO Kevin Cornwell about his company’s traumatic disruption under abusive FDA inspection techniques allegedly directed improperly by CDRH international affairs associate director Kim Trautman in a multi-year battle with the agency that he ultimately won in federal court in 2005.
Cornwell alleged that as “the CDRH official responsible for reviewing independently and objectively the factual findings” of the inspection, she acted to “directly shape” inspectional findings so they would “support the preconceived plan to pursue an injunction” and to “apparently” edit documents “to amplify the negative impact of any observations regarding Utah Medical.”
Other companies have had similar problems when their FDA program center involved itself too deeply in inspections.
The principle of checks and balances between the user fee-paid product review center and the exclusively taxpayer-financed field inspection force is in danger of being obscured by Hamburg’s PAG. Could center-managed inspections end up protecting center review decisions and policies, rather than the public interest?
Is it time for the ostensibly objective Old Guard to fade away?
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