Can FDA Cure Two Ills with Just One Bill?

Senator Michael Bennet, D-CO, has had enough of drug recalls. This week Bennet introduced Senate Bill S. 3690, the Drug Safety and Accountability Act of 2010, to increase FDA's authority over drug quality and safety.

According to a press release on the senator's Web site, "the bill would strengthen manufacturer quality standards, enhance the FDA’s ability to protect Americans through improved tracking of foreign manufacturing sites, and give the FDA much-needed authority to recall potentially dangerous drugs."

It seems to me that Bennet could end up tussling with two threats to drug safety: lapses in product quality and substandard ingredients. According to his site, S. 3690 aims to:

    * Require companies to institute quality management plans to ensure the quality and safety of their drugs and drug components, including strong supplier oversight; and
    * Ensure companies are able to document which entities are involved in the manufacturing supply chain for their drugs.

While these two requirements appear to be related, substandard drugs could be either the result of substandard drug manufacturing and packaging operations or potentially fraudulent active pharmaceutical ingredients or excipients. Can one bill adequately address both threats to patient safety?

FDA's inspection report on McNeil Consumer Healthcare details how quality issues can end up plaguing a revered company, and giving FDA more authority could tighten manufacturer quality. But what about the other threat: potentially fake ingredients marketed as legitimate ones that could enter the supply chain?

For instance, in a June Webcast, Rx-360 Board Member and Hovione CEO Guy Villax pointed to the threat of falsified active pharmaceutical ingredients (APIs). Villax spoke of traders obtaining APIs from these hidden sources, which could be using counterfeit chemicals or those made in rural locations that may not meet expected quality standards.

I do wonder whether FDA could have done anything differently had this bill become law back when the agency had identified what it called "a contaminant" in some recalled heparin products. According to FDA, the contaminant was "an oversulfated chondroitin sulfate," which "mimics heparin activity so closely that it was not recognized by routine testing," FDA reports. (Interestingly, the Wall Street Journal reported last month that "China never investigated tainted heparin." We still don't know how the contamination happened.)

To achieve the sort of regulatory oversight that Bennet desires to tackle those threats, FDA will need hundreds of more eyes on overseas supply chains that lead to the United States. And that will take money. And that still may not be enough.

FDA Commissioner Margaret Hamburg realizes that FDA cannot take on this task alone. "The recent problems with contaminated heparin, the melamine-tainted milk products, the international problems with diethylene glycol adulterated products and the growing prevalence of counterfeit drugs make clear that we must bring our oversight in line with the reality of the global economy," Hamburg said in June while speaking at the Woodrow Wilson International Center for Scholars. "We can conduct more inspections at foreign facilities that and we can establish strategic foreign in China, India, Latin America and other places. But this will barely scratch the surface considering the magnitude of the challenge before us. FDA simply does not have — and will never have — the resources to inspect every foreign manufacturer, or every shipment of products from overseas. Yes, we need new approaches. But more importantly — we cannot accomplish this task alone."

So the real teeth in Bennet's bill may not even be FDA's. If manufacturers must document all the sources in their supply chains, they may end up examining those chains as they have never done before. They may discover suppliers to their suppliers that they never knew existed and work to ensure their quality and authenticity.

In this manner, Bennet's bill could certainly make U.S. drug makers more cautious and diligent when choosing its suppliers, especially those located well beyond an arm's reach.

Daphne Allen

This article was sent to readers in PMP News's August 5 ePackage newsletter.

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