Guidance for Industry – Formal Dispute Resolution: Appeals above the division level

Status: Final
Date: February 2000
Target Audience: Healthcare industry professionals and study drug sponsors
Laws and Regulations:
21 CFR 10.3
21 CFR 10.75
21 CFR 312.48
21 CFR 314.103
21 CFR 312.48
21 CFR 312.48
21 U.S.C. 360bbb-1
63 FR 63978
64 FR 13591
Prescription Drug User Fee Act (PDUFA)
Federal Food, Drug, and Cosmetic Act (“The Act”)
Section 351 of the Public Health Service Act (PHS)
This guidance determines the action that should be taken to resolve any disputes between healthcare industry professionals and the Food and Drug Administration (FDA) that cannot be resolved at the division level. Also, the procedures for study drug sponsors appealing their disputes to the appropriate Office or Center level are explained.
Sections of the U.S. Code of Federal Regulations (CFR) and several acts are referenced to support how the sponsor should follow these procedures. One of these acts is the Prescription Drug User Fee Act (PDUFA), discussed for its role in dispute resolution at the Center or Office level (above the division level). Appeals to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) would constitute a Center level appeal. If the dispute cannot be resolved at the Center level, it must continue through the chain of command until a resolution is reached. In extreme cases of unresolved disputes, the appeal may be escalated to the FDA Commissioner for a final ruling. The type of dispute appealed may be scientific or procedural in nature.
The guidance emphasizes the importance of timely dispute resolution due to the magnitude of the scientific or commercial implications of an appeal. The procedural recommendations of the guidance are intended for appeals involving either PDUFA or non-PDUFA drugs (generics).
Discussed are the PDUFA-recommended time frames for settling disputes between study drug sponsors and the FDA. PDUFA goals for these time frames are evaluated by targeting a percentage of acted upon appeals for each year. “Acted upon,” here means that all associated requests for information, meetings, presentations, and granting or denying the appeal have been fully completed. The recommendations for percent of acted upon appeals from a 1997 PDUFA-related letter is presented in the guidance as follows:
  • Year 1999: 70% acted upon within 30 calendar days
  • Year 2000: 80% acted upon within 30 calendar days
  • Year 2001 and each subsequent year: 90% acted upon within 30 calendar days
During the resolution process, the sponsor has the right to request a scientific review from an advisory committee, if necessary. Also, a written request must be submitted to CDER or CBER as appropriate, but only after all efforts to resolve the dispute at lower levels have been exhausted.
Non-generic drug disputes must be submitted to the Formal Dispute Resolution Project Manager (DRPM) of CDER, while generic drug disputes are submitted to the Director of the Office of Generic Drugs. CBER-related disputes must be sent to the DRPM specific to CBER.
The guidance is an overview of exactly what must be included in the information sent with the dispute. There should be a cover sheet, application number, product name, description of dispute, original agency decision, list of necessary supported documents, statement explaining what transpired at previous level of attempted resolution, and sponsor contact information.
According to the guidance, the FDA will notify the sponsor in writing or via telephone of the resolution of the dispute within 30 days. If more time is needed, the FDA will still contact the sponsor within the 30 day window to explain why they need more time to process the appeal. If an advisory committee is approved to be involved in the decision, it could take longer because the committee has to be organized to evaluate the appeal, and there might be a waiting period for the next available meeting to discuss the issue.
After reaching a decision, the advisory committee notifies the FDA of their decision, and the FDA has 30 days from that point to notify the sponsor of the FDA decision. The FDA decision will not necessarily be the same as the advisory committee’s, but the committee’s decision could still provide valuable information supporting or rejecting the sponsor’s position on the disputed issue.
This guidance aims to speed up the FDA’s dispute resolution practices for scientific and procedural issues that develop during a study drug product’s development and review processes.
Resulting Recommendations:
There is a need for a quick turnaround on the appeals process so that the study drug sponsor can proceed with the next scientific or commercial action needed, and not lose time while waiting for decisions on appeals. If the procedures recommended in this guidance are followed by study drug sponsors, the sponsors will benefit from improved time frames.
Scientific and procedural disputes are resolved more quickly. CDER and CBER employees at the supervisory level have a defined process to advise sponsors if the issue is beyond their level of resolution capabilities. Study drug sponsors know what is expected from them and what they can expect from the FDA in terms of time to resolution, when a dispute is raised beyond the Division level.
For more information on this issue, contact the Kulkarni Law Firm.