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  1. Generic Drugs

Generic Drug Cluster – One-Year Progress Report

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Generic drugs play an important role in helping to address rising health care costs and in promoting access to medicines. Development and availability of generic drugs is a challenge in the United States and globally. In addition, requirements and scientific approaches to developing and assessing generic drugs can vary from country to country. To help address all of these issues, FDA established a multi-country forum, the Generic Drug Cluster, to achieve a common understanding of each member agency’s generic drug regulatory requirements and to help increase scientific alignment.

During its inaugural year, FDA and other leading regulatory agencies within the cluster conducted a series of meetings in which they collaborated on several regulatory topics. According to members of the Generic Drug Cluster, in an increasingly globalized pharmaceutical market, collaboration between drug regulators is critical. Actions taken in one country or territory can affect others. With variations in the regulatory approaches of each country, harmonization can be better achieved through a more transparent understanding of each counterparts’ approaches, with appropriate confidentiality commitments in place. If cluster members can work to harmonize scientific perspectives where possible, this can help streamline industry's interactions with individual agencies, which helps facilitate timelier patient access to generic drugs.

Forum for Information-Sharing

The Generic Drug Cluster offers a forum for the world’s leading regulatory agencies to better enable harmonization by early communications and collaborations related to generic drug development especially related to individual drug products and approval. The cluster provides an opportunity to expand a rich scientific and regulatory exchange among the participating regulatory agencies. While several other types of discussion groups exist to review relevant scientific and technical standards for drugs, such as the International Council for Harmonisation (ICH) whose focus is on harmonization and consensus, the establishment of the Generic Drug Cluster created a different focus. The cluster’s focus is to develop early open communication to establish alignment proactively whether related to a specific proposed generic drug product review or more broader drug class issue. This prospective communication paves the pathway to convergence and harmonization at an earlier phase in the development of regulations for generic drugs, thereby creating bridges across regulatory foundations through continuous communication among the participating countries agencies.

Forum to Confidentially Collaborate

Systematic exchange of information and expertise among the agencies can assist in deciding a best course of action on any given topic. Agencies often deal with complex drug safety issues at the same time as each other. The framework of the cluster allows the agencies to develop a deeper understanding of each other’s approach and actions in response to issues such as safety and drug shortages. Overall, greater information sharing may improve the quality of information an agency has to consider in reaching decisions and may lead to better outcomes for patients.

There is also a benefit to industry when agencies increase their collaboration. If a cluster group among several agencies works to harmonize scientific requirements where possible, this can help streamline industry’s interactions with individual agencies and allows industry a submissions path that is more efficient and which can lead to lower costs for applicants and patients.

In preparation for the Generic Drug Cluster discussions, the Office of Generic Drugs carefully established procedures for topic proposals to maximize the utility of the meetings as well as for adhering to confidentiality agreements that are already in place.

The scientific exchange and discussion at Generic Drug Cluster meetings promoted an understanding of approval basis focusing on a number of generic drug applications of high priority, as well as scientific rationales for the approval of complex drug products. Application data sharing among cluster members allows individual agencies to gain and expand access to respective application data and gain comprehensive knowledge of regulatory assessments. Cluster meetings so far have included a recurring discussion to compare and evaluate regulatory approaches, assess similarities, and identify differences. Some of the topics discussed include Narrow Therapeutic Index Drugs (NTI)/Critical Dose Drugs classification and evaluating and recommending alcohol dose-dumping studies. The cluster members also shared progress made in model-integrated bioequivalence for long-acting injectable products.

Year One Accomplishments

During its first year of engagement, the Generic Drug Cluster meetings enabled an agreement for gathering and assessing data from participating agencies concerning an oncology treatment. The assessment by the agencies of that combined data may lead to a faster approval pathway for that type of drug or drug class in a critically needed cancer treatment.

Additionally, the cluster came to agreement for data gathering and combining to assess the bioequivalence of a mental health treatment. This assessment of the combined data may lead to a faster approval pathway for this class of drugs used to treat mental health disorders.

Cluster participants agreed to share data on human testing of certain drugs in which there are discrepancies in the testing populations (patients vs. healthy volunteers). The assessment of the combined data could support converging recommended testing populations. Finding no statistically significant difference in patient vs. healthy volunteer populations means the door is open for a wider pool of people from which to find testing participants for these classes of drugs. A wider pool of potential testing populations could help expedite time to approval of some drugs as there would be a more plentiful and quicker availability of test volunteers.

The cluster is currently establishing a process for sharing data integrity concerns pertaining to bioequivalence and pharmacokinetic data in generic drug applications. The integrity and quality of the data that establishes bioequivalence is fundamental for approving generic drug products that are equivalent to a brand. The sharing of data integrity concerns, speculations, and findings within a structured and secure information-sharing environment can help agencies deploy protective measures to ensure effective response to threats as they arise. For example, agencies could alert members of potential data integrity concerns and clear messaging from “the regulators’ collective voice” as issues become apparent rather than just prior to taking regulatory action.

Next Steps

Information exchange and discussion at the Generic Drug Cluster meetings support FDA efforts to reach scientific consensus of approval standards for various drug products, including complex drug products. Such discussion can serve as a basis for future ICH guidelines used for the development of complex drug products. It is the goal of this cluster to collaborate early in the regulatory process so that agencies participating in the cluster can facilitate the development and approval of various generic products in a more efficient way with similar standards. This will ultimately enable patients around the world to access high-quality generic drug products in a cost-effective manner.

Generic Drug Cluster – One Year Progress Report submitted by Sarah Ibrahim, PhD., Associate Director for Global Generic Drug Affairs, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA), sarah.ibrahim@fda.hhs.gov

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