“FSMA clearly does not provide FDA with unlimited records-access authority,” the NGFA emphasized. “For example, while access to specific consumer complaints pertaining to the suspect (product) may be appropriate within a certain situation, FDA’s authority clearly is limited to accessing only those consumer complaints ‘needed to assist’ the agency in making a determination” (about a given product or similarly affected products) that are under investigation, and not to other consumer complaints that are unrelated or do not pertain to those specific products for which expanded records access is sought.”
- FDA needs to appropriately maintain confidentiality of protected information obtained as a result of utilizing its expanded records access authority. The NGFA noted that FDA’s draft guidance references that information obtained may include a company’s nonpublic confidential commercial and trade-secret information. “We urge FDA to develop ironclad procedures and redundant safeguards to vigorously comply with all legal obligations and requirements to prevent unauthorized disclosure of a company’s proprietary and/or confidential business information,” the NGFA urged, noting that inappropriate release of such information as manufacturing processes, product formulation, customer distribution lists, complaint records and other documents could cause “irreparable damage” to a company’s business.
- FDA’s guidance document should be geared to and directed at inspectors. In addition, the NGFA strongly recommended thorough training for FDA inspectors and other staff concerning the criteria and parameters contained within the guidance document that define the scope and limits of the agency’s expanded records-access authority.
“We believe our recommendations, if incorporated into FDA’s final guidance, will enhance the understanding of both the regulated industry and inspectors concerning the appropriate application of the agency’s expanded records-access authority,” the NGFA concluded.