I Received an FDA Regulatory Advisory Action Letter, Now What?

By Christina Sanchez Miller, MPH   06/11/2019

  Category: Regulatory

The biologics industry is heavily regulated with FDA’s ever-changing landscape of regulatory components. The FDA has an objective to ensure biologics companies are providing safe and effective biological products to the public. The Center for Biologics Evaluation and Research (CBER) is responsible for the review and compliance over biologics companies, includingbiologics manufacturers, blood banks, tissue banks and organ procurement organizations. One method of CBER fulfilling this objective is to disburse regulatory advisory action letters. It is for this strategic reasonthat biologics companies have a contractual relationship with a biologics consulting group. A biologics consulting group will advise when and how their clients should respond to the regulatory advisory action letters.

What are the different types of Regulatory Advisory Action Letters?

The purpose of the regulatory advisory action letters is to encouragevoluntary corrective action before initiating an enforcement action. Each response will be different and will depend upon what type of regulatory advisory action letter the biologics company received. The different types of regulatory advisory action letters issued by FDA CBER are:

  • FDA Untitled Letters
  • FDA Warning Letters

FDA Untitled Letters

FDA Untitled Letters are the least severe of all regulatory action letters distributed by FDA CBER. The letter is an initial communication used by CBER to identify violations of the biologics company. This signifies that although violations are present, they are not significant enough to warrant an FDA Warning Letter. FDA Untitled Letters are usually the result of CBER’s surveillance of websites, advertising, or promotional labeling. A biologics consulting group will recommend acknowledging receipt of the letter and address any queries with the FDA immediately so that the violations may be addressed to CBER’s satisfaction.

FDA Warning Letters

An FDA Warning Letter is considered informal but is a bit more serious than FDA’s Untitled Letter. The FDA Warning Letter is issued to encourage voluntary compliance and also serves as the establishment of prior notice. The violations documented by CBER in the FDA Warning Letter are of more regulatory significance than those cited in the FDA Untitled Letter. A biologics consulting group will try to prevent their client from ever receiving such a letter through FDA mock inspections or by reviewing the standard operating procedures manual. FDA Warning Lettersare available for public inspection through FDA’s website and third parties disseminate this information to the public. Some contracts with clients and vendors require notification if a manufacturer receives such a letter. In this case, the manufacturer could lose current or potential clients and vendors. Once an FDA Warning Letter is received, a biologics consulting group will help develop a well-designed response and corrective actions that will suffice FDA.

FDA regulatory advisory action letters should serve as a wake-up call to your quality management department. A thorough review of procedures is critical to ensure quality systems are in place to prevent such letters in the future. A biologics consulting group understands that the receipt of a regulatory advisory action letter can mean the loss of business relationships which can affect the bottom line of the biologics company. It may be beneficial to retain a biologics consulting firm that has experience in the prevention or mitigation of regulatory advisory action letters.

Author Information

Christina Sanchez Miller, MPH has over 20 years of management, biologics, quality assurance and research experience in the medical field. She is a published author in scientific books, papers and has presented at several international conferences. Christina has developed medical applications in the biologics field. Her experience includes operations and consulting in FDA Adverse Event Reporting, FDA Product Deviation Reporting, FDA 483’s, cGTP’s, infection control, certified ISO Class 5, 7, 8 development and maintenance, QIC and auditing.

BRG is a global scientific & regulatory consulting firm with extensive experience in the strategic development of drug products, biologics, medical devices, combination products and in FDA regulatory affairs. BRG is a biologics consulting group focusing on BLA, FDA Regulatory Action Letters, and Biologics Combination Products.  The opinions and statements in this blog are those of the authors and do not necessarily reflect those of BRG. This blog is based on personal experience and reviews of information publicly available or identified in other database searches.

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