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Panel I of a Hearing of the Health Subcommittee of the House Energy and Commerce Committee - Drug Safety Provisions of the Food and Drug Administration Globalization Act Discussion Draft Legislation

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Location: Washington, DC


Panel I of a Hearing of the Health Subcommittee of the House Energy and Commerce Committee - Drug Safety Provisions of the Food and Drug Administration Globalization Act Discussion Draft Legislation

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REP. JOSEPH PITTS (R-PA): Thank you, Mr. Chairman.

You stated that FDA cannot rely on inspections as the primary means of ensuring product safety and that any legislation should allow FDA to set requirements and priorities based on a strong scientific- FDA risk assessment.

Can you explain that further?

MS. WOODCOCK: Certainly.

We have, as I said, we have developed a modern program for pharmaceutical quality which -- it involves a quality systems approach. And quality systems is what is used to ensure quality in many industries -- for example, semiconductors, aeronautics, what have you; cars, automobiles. That involves control of every part of the manufacturing process from the components, the supply chain of each component, understanding the manufacturing process, having a scientific understanding of the product, and then making sure all the systems around that are under a state of control.

When we do an inspection, what we do nowadays -- a modern inspection makes sure that those systems are functioning. We don't serve as the quality control unit for the plant. We make sure they have one and that they have a quality assurance program that is functioning and that they are managing their supply chain.

So we need to make sure that the scientific standards are in place, that the entire supply chain is under control -- and that includes, for example, the brokers, the Customs agents at the borders, the distributors inside the United States -- as Ilisa was saying. Any place that chain is broken, then quality problems can be introduced into the product or counterfeits, for that matter.

So inspection is a form of verification that the systems that are in place are working. But those systems have to be run by the manufacturers, by the importers and so forth. They have to act properly for this -- for the quality of the product to be maintained.

REP. PITTS: Can you describe the type and scope of training that FDA inspectors receive? How long, on average, does it take for an FDA inspector to be fully trained to conduct facility inspections?

MS. WOODCOCK: It takes about three years, and there is a rigorous progression of training.

Furthermore, a number of years ago we established something known as the pharmaceutical inspectorate, which is even another level of training, to allow our inspectors to be fully able to inspect modern, complicated pharmaceutical operations.

So that takes about three years to be an investigator. And then, if you're going to be a foreign investigator -- investigate foreign facilities -- we'd like our inspectors to have a number of domestic inspections under their belts and be well trained at that before they go and deal with the challenges of another country -- additional languages and so forth.

REP. PITTS: How long would you estimate it would take the agency to recruit and train a sufficient number of new inspectors to conduct the requisite number of foreign inspections? And are there any difficulties or challenges that FDA faces in recruiting and training new inspectors?

MS. WOODCOCK: Our difficulties are mainly, I would say, resources. We are -- brought on a very large number of investigators in 2001 after that crisis and we were able to get them on board and begin their training.

But regardless of how many we would hire, it would take us three years to train them up and even if we're talking about a foreign inspectorate and fully trained investigators who can work on their own in foreign countries. So there is a significant training component and we would have to keep working on that over a number of years.

And that's why my estimate for the resources was a 2011 estimate -- the trajectory we would get to by 2011.

REP. PITTS: And that would permit you to make how many foreign inspections?

MS. WOODCOCK: That was an estimate of what would be required to inspect 50 percent of the firms each year of the inventory abroad.

REP. PITTS: Okay.

There's been a lot of discussion about manufacturers of active pharmaceutical ingredients. Does the FDA currently have the authority to inspect those facilities? And do those inspections differ from inspections conducted on facilities making a finished product?

MS. WOODCOCK: Yes, we definitely have the authority and we do inspect manufactures of active -- the manufacturing plants for active pharmaceutical ingredients. They are different in the sense that they're making different kinds of products. They're making bulk ingredients, rather than finished pharmaceuticals. They're not making pills or vials of product. They're making an ingredient that goes into, then, a finished product.

So in that respect it's different. But the basic fundamentals of inspecting the quality systems are very much the same.

REP. PITTS: Okay.

Thank you, Mr. Chairman.

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