Can FDA Walk the Talk on Standards?

FDA’s Office of Product Quality needs a change agent. Ali Afnan has a suggestion.

By Ali Afnan, Principal, StepChange Pharma

Change is an integral part of the very cycle of existence. We all know this, yet most of us resist change, as it upsets our sense of balance and disrupts the calm. Yet our survival depends on our coping with change.

When it comes to change, and resisting it, regulatory agencies are no different from the rest of us.

But, somehow, government bureaucracies have evolved particularly resistant responses to change, either delaying it or systematically resisting it for as long as possible. The media love to report on this, on an hourly basis. If you need to see it in action, just watch the Brit com TV series, Yes, Minister, broadcast in the 1980s.

During the course of my employment with the FDA I witnessed three different commissioners declaring the Agency to be science-based and transparent.

None of them lied outright, yet reality wasn’t always aligned with the statement. For instance, CDER in particular, would assert its support consensus standards and its adherence to OMB-A119.

However, in closed door meetings with industry, influential office directors would often, categorically, state the opposite.

Another symptom of this discrepancy between ideal and reality was the creation of new terms for old practices. This ensured “business as usual,” cloaking the status quo in the garb of innovation and drive for quality.

Is the manufacturing of pharmaceuticals so unique that we could ignore Juran’s universally accepted thesis on quality and create new language and practices to achieve the same? How could our “invention” deliver the same when it so drastically differed from the tried and tested?

OMB-A119 is not binding on non-U.S. regulators, but is binding on the FDA. But why engage in producing guidance on quality systems and ignore the well-polished ISO standards on the same subject?

For example, ISO 9001 addresses quality systems, process improvement; it is the best common practice embraced by the manufacturing industries. Is turning away from the tried and tested consensus standards good practice, sound science, or even transparent oversight?

Or is it that in the last decade the Agency has actively fought change, and some within turned a blind eye?

Just prior to my decision to leave the Agency I was reminded by a colleague that change at FDA would be evolutionary, not revolutionary. This was true, and I was willing to accept evolution, but I could not cope with the active prevention of change and progress. After all, evolution is a process influenced by needs and environment.

The need for change in our industry is great. Science-based oversight, where regulators audit the work of the scientific community would facilitate that change.

I remember in the last months being asked how I would feel if the PAT guidance was withdrawn, and if ICH Q8 were to be used to manage innovation. Some of you in the industry may even recall such conversations during your drug application meetings with the Agency. My response was that I was happy with whatever the management of FDA felt was in the best interests of the public.

Privately, I decided to remove myself from the scene and wait until common sense could prevail. I don’t believe that guidance is obsolete—it was championed in the 1930s by other industries but was, and still is, new to pharma. Even today I believe the PAT guidance can deliver quality by design if embraced.

CDER chief Dr Janet Woodcock has announced some pending changes at CDER. This promises to be a true “rocking of the boat.” Will the practice and spirit of CMC review and compliance change?

Will other aspects of review also change? I hope that Dr Woodcock manages the change and sees it to completion, regardless of the pain or resistance that she may encounter within FDA.

A firm commitment to change will need the selection of a unique individual for the directorship of the new organization, OPQ. This individual’s vision will determine whether change succeeds or flounders. He or she must be committed to change; must understand how to work with the cadre of staff; know the processes of the Agency to be able to chart the path of change. In addition, the new director should be an honest standard-bearer; a true public servant and true scientist; actively open to dialogue; and a team-builder—someone who will listen to his/her staff and rely on their expertise.

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