The warning letter noted that the facility was identified in a pending and/or approved ANDA (Abbreviated New Drug Application) on the dates for self-identification for FY 2013 and 2014.
“The facility has self-identified for 2013 and 2014 but, has not paid the 2013 or 2014 facility fees as required by GDUFA [Generic Drug User Fee Amendment]. Therefore, all finished dosage forms of drugs or APIs, as well as drug containing an API, manufactured at the facility are misbranded,” the FDA warned.
But the problems for Marck Biosciences extend beyond their failure to pay the facility fees. The firm was cited in a warning letter in August for data falsification and unsanitary conditions.
Marck did not respond to a request for comment.
Other Firms
Germany-based CMO CPM Contract Pharma in 2013 became the first firm to receive a warning letter for failing to pay a facility fee.
Twenty-seven firms are included on this year’s arrears list for GDUFA facilities. Meanwhile, 20 other firms, including Pfizer, Bristol-Myers Squibb and AstraZeneca are included in a list of companies with outstanding facility fees.
Only facilities that manufacture positron emission tomography drugs are exempted from the facility fee and other GDUFA fee requirements.
Foreign generic firms saw a more than $40,000 increase in facility fees in 2014 when compared with the fees for 2013.