FDA balks at accepting all EU plant inspections

The FDA talks a lot about how working with other countries, sharing information and insights, can allow it to stay on top of of the ever-expanding global supply chain while working within a finite budget. But even with Europe, whose geography includes countries as different as the U.K. and Romania, it can be harder to walk the walk than to talk the talk.

Europe has said during recent trade talks that it is willing to accept FDA inspections of foreign plants, but the U.S. can't bring itself to accept inspections by all European countries, the Wall Street Journal reports. That is a big disappointment to drugmakers there who had hoped to eliminate at least some of the what they see as unnecessary paperwork and red tape from having to deal with multiple inspections.

"We see a lot of duplication of resources, as a high level of domestic inspections in the EU member states coincide with a high level of foreign inspections," the European Federation of Pharmaceutical Industries and Associations, told the Journal in a statement. Members of the federation include U.S. firms like Merck ($MRK) and Pfizer ($PFE), as well as EU-based companies.

The concept of sharing the workload is sound. If you can share inspections, particularly in developed countries, then you can target the resources you have in countries like China and India, which produce a lot of drugs and active pharmaceutical ingredients used in the U.S. but where standards often don't measure up to FDA expectations.

Howard Sklamberg

The U.S. currently has more than 60 agreements with other countries to share inspection data "and other non-public information" about manufacturing at plants, Howard Sklamberg, FDA deputy commissioner for global regulatory operations and policy, pointed out on the FDA's blog last week. And he said the U.S. intends to work more closely with Europe on inspections there. "This is an effort to determine how we can deepen our mutual reliance, in what ways and how quickly," he said.

But the WSJ points out the U.S. is just not ready to agree that all inspection agencies in the 28-country European Union are created equal. And the EU continues to expand, which would leave the U.S. to accept even more countries as they join. Just last year, Croatia became a member. It was in that country in 2012 that there was a fatal explosion at a plant operated by Pilva, the Croatian company owned by Teva Pharmaceutical Industries ($TEVA).

It is not just the FDA that is balking at the proposed agreement, Peter Chase, vice president of the U.S. Chamber of Commerce's European program, told the WSJ. It is a problem that regulators in other industries also share, given that they have ways of doing things developed over decades. "It puts the regulators in a context that they're essentially unfamiliar with."

- read the WSJ story (sub. req.)
- more from the FDA blog