FDA Issues Dispute-Resolution Guidance

On Jan. 11, the US Food and Drug Administration (Rockville, MD, www.fda.gov) issued its Guidance for Industry: Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP as part of its initiative on Pharmaceutical CGMPs for the 21st Century.

The 13-page guidance for human and veterinary drug makers (both small molecule and biological) outlines a two-tier process for addressing disagreements over Form 483 inspection observations. Increasingly complex processes, coupled with last year’s Federal District Court decision, in which a federal court found for a Utah medical device company in its dispute with FDA over CGMP interpretations, may prompt more regulated manufacturers to challenge inspection reports with which they disagree.

The guidance states: "When a scientific or technical issue arises during an inspection, we recommend that the manufacturer initially attempt to reach agreement on the issue informally with the investigator."

If the dispute cannot be resolved, the manufacturer should begin a formal resolution request within 30 days of receiving the Form 483.

At Tier One, the dispute is taken to FDA’s Office of Regulatory Affairs through the district office, and will then involve the appropriate FDA center (i.e., the Center for Drug Evaluation and Research, the Center for Biological Evaluation and Research, or the Center for Veterinary Medicine). The Agency then has another 30 days in which to respond (though extensions are permitted).

If the drug maker disagrees with the Tier-One decision, it can then make a Tier-Two request, for review by a Dispute Resolution Panel (part of the FDA Commissioner’s Office). The panel includes representatives from each of the program centers and from the Office of Regulatory Affairs, plus the head of the agency’s Council on Pharmaceutical Quality. Officials involved in the Tier One decision will be excluded from the panel. The panel can call for "internal and external experts" and for legal advice. The panel has 90 days in which to meet to review the dispute and then 30 days in which to issue a response.