FDA May Lead Industry to Water, But Will It Drink?

April 1, 2004
If your processes are under control and well understood, FDA can do things very differently

FDA May Lead Industry to Water, but Will it Drink?

The advance billing promised a candid discussion on "what to expect from FDA." But that turned out to be only half the story.

Indeed, when Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER) joined a panel of pharmaceutical manufacturing executives for the keynote discussion at last month's Interphex conference in New York, attendees heard every bit as much about what FDA expects of pharmaceutical manufacturers as what they could expect from FDA.

After an obligatory status report on FDA's latest initiatives, Woodcock challenged those in attendance to reinvent themselves and their relationship with FDA to deal with a future that promises to be very different from today. "We don't have a choice--the whole system cannot go forward this way," she said, referring to archaic regulatory practices that have conspired to stifle innovation and mire the industry in inefficiency. "Times are going to change more than we think," Woodcock added. "You're going to need agility--and you don't have it now."

Clive Bennett, president of Canadian contract manufacturer Patheon (Mississauga, Ont.), was among the panelists who admitted the pharmaceutical manufacturing industry's backwardness, blaming it in no small part on regulators. "Industry has fossilized in many ways through fear of enforcement," he said.

"In the past, we've blamed the FDA" for not making improvements to manufacturing processes, added Fabrizio Bonanni, senior vice president of manufacturing for biotech leader Amgen (Thousand Oaks, Calif.). "But we're in this together. We have to rethink our resistance to change."

For its part, FDA has been working hard to recast its regulatory activities and its expectations of industry according to a "risk-based" approach, which, according to Woodcock, might have better been entitled a quality-based approach. Quality improvement, in the sense of reduced variability, has a direct connection to improving manufacturing efficiency and reducing unit costs. This concept applies not only to how the industry operates, but also to how FDA executes its oversight function.

"Part of the problem was that we didn't know what influenced product quality," Woodcock admitted, in describing FDA's traditional reliance on dotted-i and crossed-t enforcement. "We treated everything the same--every deviation was a threat to product quality. But if your process are under control and well understood, we can do things very differently," she offered.

Just how differently, it'sclear, will depend on the pharmaceutical manufacturing industry. Are you ready to gain understanding and control of your processes, embrace new technologies and continuous improvement, and work with FDA to redefine what it means to be compliant with federal regulations?

And while the recent departure of FDA commissioner Mark McClellan has some wondering whether the winds blowing from Washington will shift yet again, it's also clear that industry can't afford to stand still.

"There has to be trust," Woodcock urged. "Where else can we go?"