FDA threatens drugmaker with ban for not paying user fee

The FDA user fee programs were expanded this year to include generic drugmakers and API producers to provide the agency with extra funds for things like increased inspections of foreign manufacturers. But to collect the fees, the FDA has to know what companies are supposed to be paying them, and for that it required self identification. The penalty for not stepping up? Well, the FDA has now issued its first warning letter to a company that it says failed to, threatening to cut off its imports.

C.P.M. Contractpharma in Feldkirchen-Westerham, Germany, was the recipient of the warning letter. The FDA pointed out the deadline for identifying itself for 2013 was December of last year and that the fees should have been paid by March 4. The deadline for getting registered for 2014 was June 1 of this year. C.P.M. missed all of those.

The FDA said that because the company has not paid its fees, its products are now considered misbranded, and that can lead to having them banned from the U.S. and seized if they show up at a border. The FDA said the company needs to be in touch in 15 days and let it know what it intends to do about its past-due accounts.

The FDA has had a few other issues this year getting its hands on the user fees, which are slated to provide the agency with $6.4 billion over 5 years. The fees were threatened by automatic federal budget cuts as part of sequestration that went into effect Jan. 1. They were quickly exempted so the agency could keep doing its work. The fees now are what is keeping the agency operating and plant inspections in process. They are the money the agency can continue to use during the government shutdown that occurred this week after Congress could not come to terms on a new budget bill.

- here's the warning letter

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