FDA Adopts New Strategies to Oversee Global Economy - Pharmaceutical Technology

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FDA Adopts New Strategies to Oversee Global Economy
A Q&A with FDA Deputy Commissioner Deborah Autor.

Pharmaceutical Technology
Volume 36, Issue 7, pp. 26-34

PharmTech: During the heparin crisis, for example, would more timely information on the pig virus have alerted FDA and industry to be on the lookout for adulterated product?

Autor: Yes, both industry and FDA need to be more aware of red flags for emerging risks. In the heparin situation, there was a virus killing pigs in China that caused a shortage of heparin and rising prices. We know from history that when there's strong demand, diminished supply, and high prices, that is an opportunity for criminals to step in. So we need to be smarter about looking for those kinds of things. That applies to regulators, but it also means that industry should be paying attention to what's going on in their markets; looking at procurement of components is a very important aspect of business.

PharmTech: Do manufacturers do enough to ensure product quality?

Autor: What I hear from the pharmaceutical industry is that the quality side and the supply side aren't always connected. So you have someone who is out buying components, and they're just looking for a slightly less expensive supplier. But they may not take into account the full range of costs associated with a less expensive component.

Often a component may be cheaper to buy, but it may be made at a facility far away, which is harder to really have a handle on from a quality perspective. It may be that, in fact, that component could cause a serious product quality problem, which ultimately could cost the company much, much, much more money than it ever saved by knocking a penny or two off the price of the component.

PharmTech: Do you think industry is getting this message?

Autor: I think there have been a lot of good efforts underway recently. For example, I think Rx–360 [the international pharmaceutical supply chain consortium] is a great way for industry to work together to share information, both about specific suppliers and about emerging risks and issues.

My view is that there is a range of companies. There are some that, frankly, I think are still not as proactive about quality as they could be. There are some companies that really do constantly aspire to best practices, there are others that don't, and then there are some in between. What I often hear in those situations is that there may be people in the quality units who are very vocal proponents of this, but they may not always get the attention and the resources they need from high levels of the companies.

Other industries—aerospace, automotive—have really grappled with the challenges of globalization and outsourcing and put in systems that aren't necessarily replicated in the pharmaceutical industry. There is a lot of information in the literature about how investing in quality pays dividends, and some companies have embraced that. It really starts at the very beginning in understanding your process and your product, and goes on to understanding your suppliers and your supply chain.

Ultimately, some of the risks [from producing low quality drugs] are just devastating, as with the incidence of glass particles in vials of injectable drugs. That cost industry at least $250 million. As I understand it, glass production processes can make the glass vulnerable to this damage, and a lot of very expensive injectable products had to be recalled. And the heparin crisis cost Baxter at least $30 million in sales and $4.7 billion in market capitalization. So these can be really devastating.


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