FDA Flexes GDUFA Enforcement Muscle; Issues First Warning Letter to Non-Compliant Manufacturing Facility

October 2, 2013

By Kurt R. Karst –   

It was not a question of whether, but when FDA would issue its first Warning Letter to a facility covered by the Generic Drug User Fee Amendments of 2012 (“GDUFA”) that failed to self-identify its facility and pay applicable user fees.  That day has come.  In a September 17, 2013 Warning Letter posted on FDA’s website earlier this week, the Agency says that Feldkirchen-Westerham, Germany-based C.P.M. Contract Pharma GMBH & Co. KG (“CPM Contract Pharma”) failed to self-identify its Finished Dosage Form (“FDF”) manufacturing facility and pay applicable user fees.

GDUFA establishes four types of user fees that together generate funding for FDA each fiscal year.  One of the fees – the annual facility fee –  must be paid by both FDF and Active Pharmaceutical Ingredient (“API”) manufacturers.  Facility fees are the most significant of all GDUFA user fees, and FDF facility fees in particular (see our previous post here).  The API and FDF facility fees are based on data submitted by generic drug facilities through the so-called self-identification process (see here and here).  In a draft guidance document titled “Self-Identification of Generic Drug Facilities, Sites, and Organizations,” and in an accompanying Q&A, FDA lays out the so-called “self-identification process.”  As explained in the draft guidance:

Self-identification is required for two purposes.  First, it is necessary to determine the universe of facilities required to pay user fees.  Second, self-identification is a central component of an effort to promote global supply chain transparency.  The information provided through self-identification will enable quick, accurate, and reliable surveillance of generic drugs and facilitate inspections and compliance.

Facilities that fail to self-identify and pay applicable user fees are subject to some pretty significant penalties:

  1. Identification of the facility on a publicly available arrears list, such that no new applications from the person that is responsible for paying such fee, or any affiliate of that person, will be received by FDA;
  2. New generic drug submissions to FDA that reference a non-compliant facility will not be received unless the fee is timely paid; and
  3. All FDFs or APIs manufactured in such a facility or containing an ingredient manufactured in such a facility are deemed misbranded under FDC Act § 502(aa).

These pentalties apply until the facility fee is paid or until the facility is removed from all generic drug submissions that refer to the facility.  The misbranding penalty is particularly harsh.  It was a point of contention during GDUFA negotiations, but we understand FDA demanded that it be included in the law to give it some teeth.

FDA’s Warning Letter to CPM Contract Pharma pulls out all the stops.  According to FDA:

The above-referenced facility is a drug manufacturing facility as defined under GDUFA.  It was identified as a finished dosage form manufacturer in [REDACTED] on the date for self-identification for fiscal year 2013 and fiscal year 2014 and on the due date for facility fees for fiscal year 2013, but has not self-identified or paid facility fees as required by that law.  Therefore, all finished dosage forms of drugs or APIs, as well as drug containing an API, manufactured at the facility are misbranded.
Your facility has been placed on a publicly available arrears list.  Failure to correct these violations promptly may result in regulatory action, including but not limited to seizure or injunction without further notice.  Your facility may also be placed on import alert such that any drug the facility manufactures will be refused admission into the United States.

FDA’s Warning Letter is the latest in a string of events as the Agency continues to ramp up GDUFA implementation.  Not everything FDA has done has been welcomed by the generic drug industry (see our previous post here); however, other aspects are improvements vis-à-vis the pre-GDUFA era.  For example, earlier this week, FDA published a detailed draft guidance, titled “ANDA Submissions – Refuse-to-Receive Standards,” providing helpful insight on the circumstances under which the Agency may refuse to accept an ANDA submission, including failure to pay applicable GDUFA user fees.  

Categories: Enforcement