CDER's Janet Woodcock: Nobody Can Really Tell Me If FDA Inspections Are Effective

By Lori Clapper, Editor

“To my knowledge, there's no detailed common understanding within the United States about what GMP compliance exactly means,” CDER Director Janet Woodcock frankly stated at an exclusive ISPE Executive Forum I attended earlier this month. “In fact, the effectiveness of our inspection programs is unknown — even to me.”

That was a bold comment that really took me by surprise, and I wasn’t alone. I later spoke with a downstream operations director from a small biotech who was also very impacted by her statement. “I found it very interesting that Janet said she basically disagrees with her own team’s inspection findings and also struggles to understand what a quality organization looks like,” he said. 

Her comments were interesting, a bit controversial, but brutally honest — and I liked that. And judging by the number of heads nodding in agreement in the audience, she hit a real pain point across the pharmaceutical manufacturing industry.

Throughout her very candid presentation, Woodcock openly bemoaned the current broken regulatory system in the United States, saying it only provides unnecessary complexity, since a manufacturing facility’s performance is only as good as the last inspector’s opinion of the GMPs. That’s a vicious cycle.

“There are not many written standards, and when they are written, they're high-level. As a result, they don't tell you whether your operations are going to make the grade or not, “ Woodcock said. She added that the goal for the pharma industry should be to run an efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high-quality medicines without extensive regulatory oversight.

That’s ironic, since the industry has seen an increase in FDA inspections. I imagine many of you experience a visit or two from the FDA each year. Still, the rate of drug shortages due to quality issues has increased 300% since 2005. But again, each inspector has different opinions about what you should do and will offer various directions and requirements based on their own personal judgment calls.  This is a big frustration that needs to be addressed.

Woodcock is with you on this.  She shared some initiatives she is working on at CDER  in hopes of bringing industry and regulators together to resolve widespread quality issues.

1. “We need to first agree on the definitions of quality versus a ‘quality system’ — which are GMPs or some other standard — before we can truly form what a quality system should be,” she related. In Woodcock’s opinion, the pharmaceutical industry needs a coalition amongst innovators, API manufacturers, OTC manufacturers, generic manufacturers, etc., so that everyone is on the same page about quality matters.
2. CDER is also undertaking a broad restructuring of its organization that is concerned with pharmaceutical quality. They aim to create an office of pharmaceutical quality that houses all review functions and the supporting sciences in one office.
3. CDER’s office of compliance would focus on the creation of quality policy, the enforcement of that policy, and would then review those policies across all sectors, including generics, new drugs, and OTC.
4. She explained that CDER is moving toward becoming an expertise-based organization. For example, there will be experts in beginning chemistry for APIs, formulation scientists for certain products, and so forth, to make sure they are matching the right knowledge-base to the proper areas for inspection.
5. They also plan to form a group charged with creating a form of measurement to quantify the state of the industry She said that this would enable her, and others, to better answer quality standards questions — more than just saying “Well, most of the industry is… good.”
6. Woodcock has also proposed to reconstitute a cross-center council in pharmaceutical quality, so that they can undertake quality issues collectively and not have disparate initiatives. 

“We aren't supposed to be overseers, we're supposed to make sure that the public has quality drugs, and there are many ways to get that done,” she expressed. “It doesn't have to mean that we micromanage the industry, but the industry has to get to a point where they can reliably produce these drugs at the highest quality.”

At the end of her presentation, Woodcock said “challenge me” and invited questions from the audience. It was a very spirited and frank discussion. Be looking for my next article, when I will share her responses to some of the most poignant questions.