Agency Warns 9 Firms for Failure to Self-Identify or Pay GDUFA Fees

In 2014, to date, FDA has issued 9 Warning Letters to firms for failure to pay their Generic Drug User Fee Act (GDUFA) fees.  The latest two letters were issued on August 26, 2014, but were posted to the CDER web page on September 8 and 16, respectively.  All 9 Warning Letters can be found here.

It is interesting to note that 2 of the Warning Letters relate to failure to self-identify and the other 7 relate to failure to pay facility fees.  As outlined in GDUFA, failure to pay fees may result in the FDA finding that “[A]ny drugs or active pharmaceutical ingredients (API) manufactured, prepared, propagated, compounded, or processed at a facility for which required facility fees have not been paid or required self-identifying information has not been submitted, or drugs containing an active pharmaceutical ingredient manufactured, prepared, propagated, compounded, or processed at such a facility are misbranded. 21 U.S.C. §§ 352(aa), 379j-42(g)(4)(A)(iii). It is a violation of federal law to ship misbranded products in interstate commerce, which includes causing such products to be imported into the United States. 21 U.S.C. § 331(a)” (emphasis added).  Misbranded drugs can be subject to FDA enforcement actions including injunctions or seizures, or denied entry into the US.  Facilities failing to pay fees will be placed on a publically available arears list and, most importantly for application sponsors, FDA will refuse to review any application that contains information that any facility for which a fee may be due fails to pay such fee.  In addition, FDA will Refuse-to-Receive any and all applications if a fee has not been paid for a facility cited in an application.

Failure to pay fees is no laughing matter, and, if you are a sponsor, someone else’s failure to pay a fee may sink your application.  Make certain you preform your due diligence and review the arears list and obtain a certification from any outside fee-paying entities that they are current with their payments.  One mistake could really cost you!

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