Pfizer and other biopharmas to FDA: Don't include CMOs in new reporting requirements on drug volume
As the FDA is looking to reduce drug shortages further by collecting more data on the volume of drugs and APIs manufactured worldwide, companies like Pfizer, Thermo Fisher, Viatris and industry groups are pushing back on new guidance that seeks to establish how that data should be collected and submitted to the agency.
The technical conformance guide, released last October, spells out the requirements under Section 3112(e) of the CARES Act, which was signed into law in March 2020 and added a new section to the FD&C Act.
Under this new section, 510(j)(3), each person who registers a drug (including repackers, relabelers and anyone that manufactures product) must report to FDA annually the amount of each listed drug that was manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution.
But in comments released this week, Pfizer is raising concerns with FDA that the guidance issued may create problems for companies that have confidentiality agreements with their contract manufacturers.
“Providing reports as required under section 510(j)(3) could be considered a breach of these agreements and may be impactful to the CMO business,” Pfizer wrote.
The company says that it believes that reporting responsibilities should be that of the “Labeler” and not the “Registrant” or the manufacturing site.
“We ask that FDA clarifies whether the information should be provided by the Labeler or each of the Manufacturing sites,” the company’s comment says.
Similarly, industry group BIO suggests that the owner of the NDA or BLA should be the one accountable for the reporting of data regardless of whether the data concerns an establishment they own or not.
“This seems like it would enable the FDA to have a consolidated view of quantity of released drug as well as the quantity of distributed drug and eliminate the gap of having the ‘Market Unknown’. Also, BIO believes that BLA/NDA owners want the accountability and responsibility of reporting our product volumes, and it seems odd that BLA owners would become an ‘authorized agent’ of an establishment (likely a CMO) represented by a ‘registrant’ that is manufacturing the product on their behalf,” BIO senior director Katherine Donigan wrote.
Viatris (formed via the combo of Mylan and Pfizer’s Upjohn) also raises concerns “that several aspects of the proposed plan are unduly burdensome, both for industry and FDA, and unnecessary to achieve the purposes of the new provision.”
The generic powerhouse points out that with over 275,000 finished and unfinished drug package national drug codes, according to FDA’s NDC directory, the agency is asking industry to compile, format, and submit over 3.3 million data points in a short amount of time — less than four months after issuing this guide.
“Accordingly, Viatris requests that FDA extend the submission deadlines for CY 2020 and 2021 information until at least six and nine months, respectively, after the Agency issues a final guidance to allow for industry to provide the requisite information in a manner consistent with the final guidance,” the company said.
Thermo Fisher also sought to extend the implementation period, noting that “an impact assessment on the resource requirements relative to the value of the data reported should be undertaken with stakeholders.”
Similarly, industry lobbying group PhRMA “encourages FDA to take a phased approach to the implementation of these reporting requirements, to describe how the Agency intends to use the reported data to mitigate against drug shortages, and to focus the Agency’s limited resources on the optimization of existing quality oversight tools and initiatives that will have the greatest impact in enabling FDA and manufacturers to prevent and mitigate drug shortages.”