MAPPing a New Route: FDA Updates MAPP on Suitability Petitions

For years, submitting a Suitability Petition has been like screaming into a void: You’d be lucky if FDA ever responds.  This has been a big problem because FDA’s inattentiveness can delay entry of certain types of ANDAs for years—often resulting in the ANDA applicant’s abandonment of the Suitability Petition.  Industry has been asking for Suitability Petition reform for years, either by FDA or mandated by Congress, but, other than a few rejected bills, such requests have basically gone nowhere.

Taking a step back, a Suitability Petition is used when an ANDA applicant wants to submit an ANDA that differs from its Reference Listed Drug in strength, dosage form, route of administration, or, in the case of a combination drug, active ingredient.  Under 21 C.F.R. § 314.93, an applicant that wants to submit such an ANDA “must first obtain permission from FDA to submit such an ANDA.”  Such an ANDA therefore can be submitted only upon the submission and approval of a special Citizen Petition, called a Suitability Petition.  Technically, FDA is supposed to review and approve Suitability Petitions within 90 days, but the reality is that it can take years for FDA to respond—if the Agency ever responds at all.

FDA now has committed under GDUFA III to actually reviewing Suitability Petitions.  Like with other types of Reviews, FDA will assign a “goal date” to any Suitability Petition submitted after October 2, 2023.  FDA has contacted applicants with pending Suitability Petitions to confirm continued interest in a response and invited those Petitioners to resubmit Petitions after October 2, 2023 to be assigned a goal date.  For context, before GDUFA III, FDA received 20-30 Suitability Petitions per year and had approximately 170 pending as of July 2021.  To address this backlog and any forthcoming Suitability Petitions, FDA’s GDUFA III commitment letter states that the Agency will review 50% of Suitability Petitions—up to 50 Suitability Petitions—within 6 months after a 21 day completeness review in FY 2024; 70%, or up to 70 Suitability Petitions, in FY 2025; 80%, up to 80 Suitability Petitions, in FY 2026; and 90%, or up to 90 Suitability Petitions, in FY 2027.  Priority is given to Suitability Petitions that could mitigate or resolve a drug shortage; address a public health emergency declared by HHS; mitigate waste by way of new strengths for parenteral products; or subject to special review under the President’s Emergency Plan for Aids Relief.  If FDA misses goal dates, it will prioritize review of those Suitability Petitions with missed goal dates prior to reviewing newly-submitted Suitability Petitions.

In late September 2023, presumably in light of the upcoming goal date assignments, FDA revised MAPP 5240.5 covering ANDA Suitability Petitions.  In the newly-revised MAPP, FDA fully integrates its GDUFA III commitments, including the goal date commitments and the priority list.  FDA also commits to conducting completeness assessments of all submitted Suitability Petitions within 21 days or issue an Information Request as necessary.  All in all, goal dates will be approximately 7 months after submission, or 6 months after completeness assessment.  But we’ll have to wait quite a few years until almost all Suitability Petitions are reviewed within their assigned goal date period.

The MAPP itself adds little new that’s interesting for industry (assuming you’ve read the GDUFA III Commitment Letter), but it reflects that FDA now may be taking seriously its commitment to reforming the Suitability Petition process.  Such a change is welcome, as it not only accelerates and facilitates competition, but it should greatly reduce industry frustration.  It’s too early to tell what kind of traction this effort will get and if FDA will be able to meet its commitments, but it’s promising that FDA has, for the first time, made an actual commitment to trying.  Those of us that have submitted Suitability Petitions after October 2 are waiting with bated breath for FDA’s completeness review and assignment of a Goal Date and to see whether FDA can meet its targets.