FDA builds program for outsourcing foreign plant inspections

FDA advisor says trade secret law puts up a roadblock to extending FDA reach
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Congress has been all over the FDA to do a better job inspecting drug manufacturing around the world. And the FDA sees promise in a program that draws help from other international regulators. Still, the program is caught in one of those pressure sandwiches between competing congressional concerns.

In this case, it's the demand for more international inspections in places like China, and concern over other countries getting their hands on U.S. trade secrets--say, countries like China.

Since 2008, the FDA has been working on a program that would allow it to essentially outsource inspections of active pharmaceutical ingredient (API) manufacturing operations in other countries to other regulators and then reciprocate with inspections it conducts. It is already working with European Medicines Agency (EMA), the European Directorate of the Quality of Medicines and Healthcare (EDQM) and Australia's Therapeutic Goods Administration (TGA). 

On March 1, the FDA published its terms of reference--essentially the rules for joining the club--and expects other agencies will want to come onboard. In fact, the the World Health Organization (WHO) recently joined after the terms were spelled out, FDA spokeswoman Sarah Clark-Lynn told inPharmaTechnologist.

The idea is that one regulatory agency can rely on inspections and documentation provided by another. There are provisions for asking each other to look into specific areas of concern so that members are sure to get what they need out of a visit.

The problem is that the U.S. is essentially asking for help but not sharing everything it knows about the plants its inspects. In testimony before a congressional subcommittee earlier this year, Peter Beckerman, a senior policy advisor to the FDA, said the FDA needs to be able to share information on manufacturing processes with other regulators if it wants to be as efficient as possible with its resources. But confidentiality agreements with companies under trade secret legislation prevent it from giving full disclosure. Sharing information about manufacturing processes just isn't the same as giving away "the secret formula for Coke," Beckerman told Congress, suggesting the law needed tweaking.

FDA's Clark-Lynn says the limitations of the law have not been to difficult to finesse. "Redaction of trade secret information takes time and reduces substantive content, but this has not significantly limited our collaboration," she said.

Of course the FDA is used to facing dueling pressures. It was severely criticized by Congress for allowing contaminated heparin marketed by Baxter International ($BAX) into the U.S. in 2008. The heparin was tied to the deaths of 80 patients. Yet, it has had trouble getting additional funding so that it can increase oversight in other countries where, Bloomberg reported, inspections have averaged once every 9 years instead of once every 30 months as in the U.S.

- get the inPharmaTechnologist story
- here's a link to the FDA terms of reference

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