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This article outlines the current process for tracking and reporting postmarketing commitments (PMCs) by the US Food and Drug Administration (FDA). In addition, it summarizes a recent Pharmaceutical Research and Manufacturers of America (PhRMA) company survey on PMCs and offers recommendations for improving the accuracy of the information available to the public on the status of PMCs.

Advisory Committees to the Food and Drug Administration provide FDA with expert advice on medical and scientific topics relevant to FDA’s responsibility to protect and promote the public health. The history and experience with Advisory Committees (since authorization in federal law in 1972) provides a rich background to inform a review of best practices. The following best practices for the Advisory Committee process are noteworthy: Role definition: A shared understanding of the roles of all participants in the Advisory Committee process helps to foster productive meetings and facilitates prompt resolution of potentially contentious issues.Transparency: FDA and sponsor should operate with transparency in bidirectional sharing of information and perspectives before, during, and after a product-specific Advisory Committee meeting.Regulatory knowledge: Advisory Committee members, special government employees, consultants, and sponsors must all have a fundamental knowledge of the regulatory principles governing the Advisory Committee process, as well as development and registration of drug and biologic products.Access and focus: FDA has an ongoing need for access to external medical and scientific experts to augment the agency’s internal experts. Consultation with Advisory Committees should be focused on situations (as described in this article) where external advice is warranted to aid FDA in efforts to protect and promote the public health.Training: Optimization of the Advisory Committee process and implementation of best practices across the multiple committees and reviewing divisions in FDA require training of all participants.

The process of development, manufacturing, registration, distribution, and postmarketing support of drug and biologic products includes the need for clear, active, and ongoing communication between the sponsor/applicant and the Food and Drug Administration (FDA). Such communication occurs in written and spoken form, involving multiple media (including letters, secure e-mail, fax, face-to-face meetings, and teleconferences). Personnel in PhRMA member companies and FDA recognize the importance and challenges of communication. FDA’s attention to a number of key principles of communication is illustrated in the guidance document Good Review Management Principles and Practices for PDUFA Products. In this white paper, members of PhRMA’s Best Practices Working Group have summarized key information on communication from the guidance document, proposed expectations for communications to facilitate a shared understanding between FDA and applicant about a communication strategy during review of a New Drug Application (NDA) or Biologics License Application (BLA), and drafted some basic principles for companies to adopt to help foster constructive, professional, and efficient communication with FDA on Prescription Drug User Fee Act (PDUFA) products. Dialogue with FDA and other stakeholders about these principles and proposals is suggested as the logical next step in discussion of best practices for communication.

This article outlines the current process for tracking and reporting postmarketing commitments (PMCs) by the US Food and Drug Administration (FDA). In addition, it summarizes a recent Pharmaceutical Research and Manufacturers of America (PhRMA) company survey on PMCs and offers recommendations for improving the accuracy of the information available to the public on the status of PMCs.

The process of development, manufacturing, registration, distribution, and postmarketing support of drug and biologic products includes the need for clear, active, and ongoing communication between the sponsor/applicant and the Food and Drug Administration (FDA). Such communication occurs in written and spoken form, involving multiple media (including letters, secure e-mail, fax, face-to-face meetings, and teleconferences). Personnel in PhRMA member companies and FDA recognize the importance and challenges of communication. FDA's attention to a number of key principles of communication is illustrated in the guidance document Good Review Management Principles and Practices for PDUFA Products. In this white paper, members of PhRMA's Best Practices Working Group have summarized key information on communication from the guidance document, proposed expectations for communications to facilitate a shared understanding between FDA and applicant about a communication strategy during review of a New Drug Application (NDA) or Biologics License Application (BLA), and drafted some basic principles for companies to adopt to help foster constructive, professional, and efficient communication with FDA on Prescription Drug User Fee Act (PDUFA) products. Dialogue with FDA and other stakeholders about these principles and proposals is suggested as the logical next step in discussion of best practices for communication.

Advisory Committees to the Food and Drug Administration provide FDA with expert advice on medical and scientific topics relevant to FDA's responsibility to protect and promote the public health. The history and experience with Advisory Committees (since authorization in federal law in 1972) provides a rich background to inform a review of best practices. The following best practices for the Advisory Committee process are noteworthy:•Role definition: A shared understanding of the roles of all participants in the Advisory Committee process helps to foster productive meetings and facilitates prompt resolution of potentially contentious issues.•Transparency: FDA and sponsor should operate with transparency in bidirectional sharing of information and perspectives before, during, and after a product-specific Advisory Committee meeting.•Regulatory knowledge: Advisory Committee members, special government employees, consultants, and sponsors must all have a fundamental knowledge of the regulatory principles governing the Advisory Committee process, as well as development and registration of drug and biologic products.•Access and focus: FDA has an ongoing need for access to external medical and scientific experts to augment the agency's internal experts. Consultation with Advisory Committees should be focused on situations (as described in this article) where external advice is warranted to aid FDA in efforts to protect and promote the public health.•Training: Optimization of the Advisory Committee process and implementation of best practices across the multiple committees and reviewing divisions in FDA require training of all participants.PhRMA member companies strive to embrace these best practices in working with reviewing divisions, the Executive Secretary of each committee, and Advisory Committees. This white paper is presented to foster further dialogue to aid continuous improvement in the Advisory Committee process.