Pharmaceutical companies have faced delays in receiving a response to their Suitability Petitions by the United States Food and Drugs Administration (US FDA). This has been a problem as delay in responses have led to the delay of Abbreviated New Drug Applications (ANDA) entering the market. The US FDA has committed to proactively reviewing the Suitability Petitions that have been submitted, under the Generic Drug User Fee Amendment III (GDUFA III).
When is a Suitability Petition required?
A Suitability Petition is required for an Abbreviated New Drug Application (ANDA) applicant seeking approval for a generic drug that differs from the Reference Listed Drug (RLD) in aspects such as strength, dosage form, route of administration, or active ingredient in the case of combination drugs. According to 21 C.F.R. § 314.93, an applicant must obtain FDA permission before submitting such an ANDA. This permission is granted through the approval of a special Citizen Petition known as a Suitability Petition.
Despite the regulation stipulating a 90-day review period for Suitability Petitions, the actual response time from the FDA can be significantly longer, often taking years, or there may be no response at all. This delay in FDA approval can impact the timely availability of generic drugs in the market
Suitability Petition vs Citizen Petition
A Suitability Petition is a type of Citizen Petition.
The Citizen Petition is a formal request that is submitted to the US FDA by pharmaceutical companies, individuals, or other organizations. In it, they express concerns they may have, providing information, or request for actions to be taken related to drug approval. A Suitability Petition is also a formal request to the US FDA that is usually made by a generic drug manufacturer, as part of the ANDA process. It looks to show that a certain attribute of a generic version is still suitable for FDA approval despite it showing some differences from the criteria. These differences could be related to formulation changes, manufacturing processes involved, Product labelling, etc.
Reforming Suitability Petition Process
Under GDUFA III, the FDA commits to addressing Suitability Petition issues. The commitment involves assigning goal dates, actively reviewing a percentage within specified time frames, and prioritising critical concerns like drug shortages, public health emergencies, waste reduction, or special reviews.
Due to a backlog, the FDA aims to review a certain percentage of Suitability Petitions within specified timeframes, according to the commitment letter: 50% within 6 months after a completeness review in FY 2024, 70% in FY 2025, 80% in FY 2026, and 90% in FY 2027. Priority is given to petitions addressing drug shortages, public health emergencies, waste reduction, or those under special review. If goal dates are missed, the FDA prioritises the review of petitions with missed deadlines before newly submitted ones.
The revised Manual of Policies and Procedures (MAPP) 5240.5 provides insights into the FDA’s operational approach to ANDA Suitability Petitions. The manual outlines the responsibilities and procedures within the FDA’s divisions, delineating the step-by-step review process.
The MAPP is effective upon publication, signalling a proactive stance by the FDA in addressing Suitability Petition challenges. By introducing goal dates and prioritising critical reviews, the FDA aims to streamline the process and reduce historically prolonged response times.
The FDAs decision to reform the Suitability Petition process in GDUFA III is a development showing their willingness to address industry concerns, in order to expedite the entry of ANDA into the US market. The updated MAPP includes guidelines, and its effectiveness will be evaluated based on the FDAs ability to achieve the set goals and timelines. Industry stakeholders are eagerly awaiting the FDAs responsiveness to petitions submitted after October 2 2023 with the hope that these reforms will accelerate the entry of drugs into the market ultimately benefiting patients and promoting healthy competition in the pharmaceutical industry.
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