How to Improve Complex Drug Development? A Critical Review of FDA Advisory Meetings
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How to Improve Complex Drug Development? A Critical Review of FDA Advisory Meetings
Pol F. Boudes, MD Bayer Healthcare Pharmaceuticals, Montville, New Jersey
Key Words US Food and Drug Administration; Trials; Effect size; Safety; Drug approval Correspondence Address Pol F. Boudes, MD, PO Box 1000, Bayer Healthcare Pharmaceuticals, Montville, NJ 07840 (e-mail: [email protected]).
Background: Food and Drug Administration (FDA) advisory committees are essential in the process to market new drugs or authorize a new indication for an approved drug. Methods: This review of 2004 FDA advisory committee meetings analyzes questions posed to panel experts, results of experts votes, and regulatory actions taken by the agency. Results: Thirteen proposed indications concerning 10 new drugs were reviewed. Oncologic drugs covered six indications. While efficacy questions were the most frequent, safety questions were the most challenging. Beyond a statistical significance, sponsors were regularly asked to demonstrate the clinical relevance of study results. This sometimes proved unsuccessful for oncology in-
In the United States, the Food and Drug Administration (FDA) evaluates requests from pharmaceutical sponsors for approval to market new drugs or expand indications for marketed drugs. In many cases, the evaluation is challenging and the FDA, through its Center for Drug Evaluation and Research (CDER), calls on advisory panels of experts to provide advice (1,2). We analyze the 2004 FDA advisory panel meetings with the aim to better address the challenges of clinical drug development programs (3). The review focuses on questions that are asked to panel experts, the results of experts votes, and FDA decisions regarding each new drug application (NDA).
METHODS The list of 2004 advisory committee meeting was established by consulting the FDA Web site (4). Included are meetings addressing the evaluation of a new drug, or the evaluation of a new indication for a drug that is already approved for another indication. Meetings dealing with general drug development questions, such as policy issues or safety consideration, are not included.
dications. An identified safety signal could be problematic if the risk of the adverse reaction for an individual patient is not properly defined or if the adverse reaction cannot be minimized. Potential safety concerns are frequently raised but are difficult to address within the current regulatory guidance as such a risk cannot be objectively defined or prevented. The risk benefit analysis of advisory panels frequently contradicted sponsors analysis. Only 4 of the 13 proposed indications presented were later approved by the FDA. Conclusion: A better understanding of the conflicting opinions between advisory experts and sponsors will improve the conduct and review of clinical programs aiming at new indications.
Advisory committee meeting materials were consulted on the dockets of the “reference room” of the FDA Web site (4). For each meeting, reviewed material included briefing documents
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