FDA Sort-of Commits to Meet with Generic Drug Manufacturers that Have Received Warning Letters

A drug manufacturer’s bad post-inspection grade from the U.S. Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility.  Many of our clients have been confounded by their inability to secure a change in the classification of the facility, or to convince FDA to meet with representatives of the owner of the facility to explain what else they need to do.

As predicted in an earlier blogpost, FDA last week released a draft guidance that provides a pathway for generic drug manufacturers to secure a meeting with FDA so that affected companies can get answers to their questions in these circumstances.  The Guidance also commits FDA to some deadlines for when requests to meet will be accepted or denied, and for when meetings will be held if granted.  “Commits” is probably not the right word, although it is a term repeated frequently in the Guidance, since the Guidance at this point is only a draft, and, like other FDA guidances, it states in a highlighted warning that it “does not establish any rights for any person and is not binding on FDA or the public.”

Still, the document provides some guidance (naturally) as to materials required to submit a successful meeting request.  And the Guidance may be used as leverage to secure action from FDA on a meeting request.  We are not aware of a similar guidance for meeting requests from manufacturers of NDA drugs.  There is a discussion of the possibility of a post-Warning Letter meeting mentioned in FDA’s Regulatory Procedures Manual, but that discussion, which is not limited to generic drug manufacturers, seems to contemplate that it is FDA, not the Warning Letter recipient, that requests the meeting (”Program offices and centers also have the option of conducting a meeting with firm’s management prior to pursuing an administrative or regulatory action”).

The Guidance which is the subject of this blogpost specifically provides that it is applicable to facilities which manufacture either generic drugs or active pharmaceutical ingredients for generic drugs.

The Guidance sets three predictable conditions for application of the Guidance: the affected facility must carry an OAI classification; the facility must have paid the GDUFA annual facility fee or be named in a pending Abbreviated New Drug Approval application (an application for approval of a generic drug), and the Warning Letter that the facility seeks to close out must address only violations of or deviations from section 501 of the Federal Food, Drug, and Cosmetic Act (generally, these will be FDA observations related to failure to comply with Good Manufacturing Practice regulations).  The Guidance advises that the meeting request not be submitted until “significant progress” toward remediation has been made.

To request a meeting, the facility must submit a meeting package with specified information about the facility; information about the suggested meeting; a list of topics requested to be addressed during the meeting; and, perhaps most critically, information about corrective actions that have been taken or are in progress to address the deviations.  The Guidance states that any supplementary materials about “remediation progress” must be submitted at least 60 days before the meeting (footnote 23), and, somewhat inconsistently, that meeting “materials should be submitted to FDA 30 calendar days prior to the scheduled meeting date” (Section IX), “or else,” as an angry parent might scold a recalcitrant child.

As to FDA commitments, the Agency, in the Guidance, states it has committed to grant, deny, or defer the meeting within 30 days of the request at least 50 percent of the time in the current fiscal year, 70 percent of the time in the next fiscal year, and 80 percent of the time thereafter.  For the remaining meeting requests, there is no goal, so FDA can respond outside of the 30-day window.

Generally, FDA anticipates that the meetings will occur “6 months or later” after the facility submits its initial response to a Warning Letter.

And, after all that, many companies may simply get a response from FDA that a decision on whether a meeting will be scheduled is deferred, pending a reinspection.  Which can take months, or even years, for FDA to schedule.