FDA Issues First Warning For Failing To Pay Generic Facility Fees

In response to ongoing concerns about generic drug oversight and a backlog of applications, the FDA was granted authority to charge user fees to generic drugmakers. The hope was to collect $299 million during the first fiscal year, which just ended. Of course, this sort of plan only works if drugmakers acknowledge their activities – called self-identifying in FDA lingo - and pay a fee. Not surprisingly, some drugmakers have not paid their fees and the FDA was, in fact, keeping tabs on the holdouts by posting a list of those in arrears. In fact, there are now more than three dozen companies on the list, as of today. Among those listed are Allergan (AGN) and Colgate Oral Pharmaceuticals, a subsidiary of Colgate Palmolive (CL) (here is the latest arrears list). Now, though, the agency has issued what appears to be the first warning letter to a drugmaker for failing to identify its practices and pony up the money owed under GDUFA. A letter was sent to CPM Contract Pharma, which claims to be the biggest contract manufacturer in Germany and produces solid, semi-solid and fluid medications (here is the letter). "What FDA is saying is we mean business and if you are going to play in the Generic sandbox you need to play by the rules. No second chances," says Bob Pollock, a senior advisor at Lachman Consultants and a former acting deputy director at the FDA Office of Generic Drugs. The fees, which were due last March, amount to more than $190,000 and recently increased by $40,000 as ...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs