Industry seeks delay for reporting manufacturing volume data

Regulatory NewsRegulatory News | 12 January 2022 |  By 

Drugmakers and active pharmaceutical ingredient (API) suppliers say they need more time to set up the necessary systems to comply with the manufacturing volume reporting provisions in the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to meet the February deadline set by the US Food and Drug Administration (FDA).
The Section 3112 of the CARES Act established new reporting requirements for manufacturers of finished dosage forms, API suppliers, over-the-counter drugs and animal drugs to report annually the amount of each drug that is manufactured, prepared, propagated, compounded or processed for commercial distribution. The manufacturing volume reporting requirement initially set to begin in September 2020, but FDA postponed the requirement a month before the statutory deadline as it had not yet set up a portal for submitting the data.
Major industry groups, including the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Association for Accessible Medicines (AAM) are requesting that the agency the delay the reporting requirement once more, or implement a phased-in approach.
The groups were responding to a draft guidance FDA issued in October intended to assist registrants in complying with the reporting requirements. The draft guidance coincided with the release of FDA’s NextGen Portal for reporting manufacturing volume data. (RELATED: FDA launches portal for drug manufacturing volume reporting, Regulatory Focus, 29 October 2021)
Comments also expressed concern that this data could be misinterpreted, pointing to potential drug shortages when none exists, and concerns of using 2020 data for 2021 reporting purposes.
The agency wants reports for calendar year 2020 to be submitted by 15 February 2022 and reports for calendar year 2021 to be reported by 16 May 2022.
Industry groups call for delay
In its comments, PhRMA asked FDA to clarify how it intends to use the manufacturing volume information and calls for a phased implementation approach and asks that FDA delay the collection of data for 2020 and 2021 to July 2022. “PhRMA suggests that the Agency undertake an initial two-year phase with only a subset of manufacturing facilities and products, during which time FDA can assess the utility of the information reported with respect to preventing and/or mitigating drug shortages,” the group writes.
PhRMA also requested that FDA allow for more time after the end of each year for companies to report manufacturing volume data. Here, PhRMA suggests allowing the data to be reported any time before 30 June for the preceding calendar year, rather than within 45 days as called for in the guidance.
Additionally, PhRMA sought reassurance from FDA that the information submitted would be confidential commercial information.
The Association for Accessible Medicines (AAM) requested that FDA delay the reporting date for 2020 data to 19 September 2022, “to allow industry adequate time to focus and prepare the more relevant 2021 data for submission by the May 16, 2022 deadline.”
“While we were not surprised by the issuance of guidance in October, the granular manner in which FDA is expecting compliance and the associated proposed/established timeframes for compliance by regulated industry presents challenges for our members,” AAM writes.
AAM said that meeting these reporting requirements will be especially challenging for companies that market a “large number of products under multiple National Drug Code (NDC) numbers and whose operations are spread worldwide among many facilities.”
The group said that “most companies we have spoken with do not have a uniform process of gathering the data FDA is asking for and must invest in implementing new or updated software to gather and prepare the data for submission to FDA. Nor do they have a process to automatically generate the data and reports set forth in the Reporting Guidance.”
One member told AAM that complying with the reporting will require 14 full-time employees working on the reporting project full-time for a seven-week period. “With respect to manual data gathering and entry, the cost for another member is about $100,000 for about 500 NDCs,” it said.
The Bulk Pharmaceutical Task Force (BPTF) requested that initial reporting be delayed at least 90 days to give API suppliers more time to meet the reporting requirements.
“Given the time it will take to identify and aggregate information, particularly when considering the requirement to include data from multiple global sites with a variety of recordkeeping systems, it will be a challenge for API manufacturers to meet the deadline for reporting of 2020 data,” said BPTF.
Pharmaceutical manufacturer Viatris agreed that the deadline should be extended to “account for the resource-intensive data gathering and compilation needed to meet the instructions outlined in the draft guidance and the need to finalize the guidance document after reviewing comments.”
Viatris said it has over 275,000 finished and unfinished drug package NDCs in its inventory, and is being asked to compile, format, and submit over 3.3 million data points to FDA “in less than four months after issuance of the draft guidance.”
Questions on how data will be used
There were also questions raised by industry that the data reported to FDA could be misinterpreted.
AAM says that “one of our concerns is that FDA may read a temporary disruption or discontinuation of an API as having an impact on the finished dosage form market where one does not exist. A temporary disruption or discontinuation of an API may not have an impact in the market, for example, because ANDA sponsors could have API stockpiles, alternative suppliers for an approved application, or a sponsor may not have plans to batch manufacture a product for many months because they have adequate supply to meet expected demand.”
PhRMA raised questions about whether the collection of site-level volume information is the best way to achieve the goal of reducing shortages and suggested that the agency continue to bolster other existing initiatives.
“PhRMA strongly supports the Agency’s current efforts to implement and optimize a risk-based framework that promotes the effective and efficient use of Agency resources to address the most significant public health risks, including mitigating drug shortages, and we are concerned that FDA’s collection of site-level product volume information does not align with the Agency’s risk-based framework. Furthermore, we are concerned that collection of this information may in fact divert resources away from initiatives that will have the greatest impact in enabling FDA and manufacturers to prevent and mitigate drug shortages,” PhRMA said.
Timing of reports
Another concern raised was the validity of using 2020 data for reporting purposes.
BPTF said that “reporting for 2020 API manufacturing presents a variety of challenges due to age of the data. Moreover, given the unusual nature of 2020, the retrospective data is highly unlikely to provide an accurate reflection of normal production activities and/or elucidate data that will be useful in preventing future drug shortages. Therefore, FDA should consider eliminating reporting for 2020.”
PhRMA proposes broader exemptions for biologics
In another area, PhRMA requested that FDA expand its reporting exemptions for certain types of biologics to cover made-to-stock cell and gene therapy products, including patient kits that are prepared for weight-based dosing. Just before the portal’s launch, FDA proposed to exempt two categories of products from the reporting requirement: blood and blood components for transfusion and cell and gene therapy products, where each lot is used to treat a single patient.
“Like the blood products and cell and gene therapy products included in the proposed order, the supply chains for made-to-stock cell and gene therapy products are well established and well-understood from information described in the biologics license application (BLA), and generally do not involve wholesale distributors, brokers, or other intermediaries,” said PhRMA.
PhRMA comment on exemptions


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