Drugmakers Raise Issues With FDA’s Field Alert Report Submissions Guidance

Regulatory NewsRegulatory News | 20 September 2018 |  By 

Drugmakers GlaxoSmithKline (GSK), Sanofi and Perrigo are calling on the US Food and Drug Administration (FDA) to make changes to its recently released draft guidance on field alert report (FAR) submissions.

The draft guidance, released for comment in July, describes FDA’s current thinking on submitting FARs for new drug applications (NDAs) and abbreviated new drug applications (ANDAs). In the guidance, FDA calls on applicants to submit a FAR within three working days of receiving information about certain issues relating to a product or its labeling, such as bacteriological contamination or deterioration.

In comments submitted to the public docket for the draft guidance, the three drugmakers point out issues in the draft guidance and ask for more clarification from the agency.

Both GSK and Perrigo say that the guidance is inconsistent with federal regulations in how it interprets the three-day reporting timeframe. Under federal regulations, the information that must be submitted in a FAR must be reported “within 3 working days of receipt by the applicant.”

In the guidance, FDA says that the day information that meets the criteria for FAR submission is identified is day 0, giving drugmakers three full working days after that date to submit the FAR to the agency. However, in an example in the guidance, FDA says that the day a contract lab learns of an issue counts as day 0, meaning that drugmakers would be obliged to report the FAR three working days from then.

“The regulations make clear that day 0 is when the NDA or ANDA applicant becomes aware of information meeting the criteria requiring a FAR,” GSK writes. Perrigo also comments that this should be the case with other contracted entities, such as contract manufacturers.

Perrigo also asks FDA for clarification in situations where it is unclear where the root cause of a problem occurred. “As supply chains and products are increasingly complex, particularly for combination products, more specific examples in this section would be very helpful,” Perrigo writes.

In its comments, Sanofi questions FDA’s authority to require FARs for products approved under an NDA/ANDA, but only distributed outside of the US.

Specifically, the guidance states that “any drug marketed under an approved NDA or ANDA, whether distributed domestically or abroad, is subject to FAR requirements.”

“If operationalized, this practice would change Sanofi’s standard processes used to identify product batches for which submission of a FAR to FDA is warranted and would result in submission to FDA of information about products that do not stand to affect US consumers,” Sanofi writes.

Sanofi also points out that FDA’s current form for reporting FARs only includes fields for US product information and asks that FDA provide a regulatory basis for requiring FARs for products distributed outside the US.

Public Docket


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy