Industry groups seek changes to FDA’s remote interactive evaluation guidance

Trade groups representing the pharmaceutical and clinical research industries endorsed the US Food and Drug Administration’s (FDA) approach for conducting remote interactive evaluations (RIE) as an alternative inspection tool but want more clarity on what FDA will provide at close-out meetings.

Industry groups also want clarity on when the agency will request a RIE instead of conducting an on-site preapproval (PAI) or prelicense inspection (PLIs). There were also calls to consolidate various guidance documents on remote inspections into one document.

The guidance, which was jointly issued by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), covers PAIs, PLIs, postapproval inspections, surveillance inspections, follow-up and compliance inspections, as well as bioresearch monitoring (BIMO) inspections.

The agency received eight comments on the guidance, which was released in October 2023. RELATED: FDA addresses use of remote interactive evaluations in post-pandemic era, Regulatory Focus 25 October 2023).

The agency began using RIEs during the COVID-19 pandemic after halting most foreign and domestic inspections during periods of heightened concern about staff safety and international travel restrictions. FDA announced in September that based on the success of using this and other tools during the pandemic, it will continue using these alternative tools. (RELATED: FDA will continue to use remote inspection tools to assess pending applications, Regulatory Focus 22 September 2023)

Groups support use of RIEs

Two major pharmaceutical industry groups, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Association for Accessible Medicines (AAM) supported the agency’s use of RIEs, as well as a major clinical research group, the Association of Clinical Research Organizations (ACRO).

PhRMA wrote, “We strongly support FDA’s use of alternative tools, including remote interactive evaluations (RIEs), to assess manufacturing facilities and we value FDA’s efforts to advance their use by publishing the draft guidance.”

AAM said that it “supports FDA’s continued use and improvement of these important oversight tools.” The group said it “believes these tools can serve as an important part of FDA’s efforts to modernize and improve the Agency’s oversight capabilities, and that these tools will strengthen public health.”

AAM said it specifically supports FDA’s plan in the draft guidance to request RIEs in lieu of conducting an onsite PAI or PLI.

“We support FDA’s clarification in the Draft RIE Guidance that the Agency may request to conduct an RIE in lieu of conducting a PAI or PLI if FDA determines that facility risks can be assessed or application assessment can otherwise be completed without inspection. This is a positive update from the COVID-19 RIE Guidance, which had indicated that FDA may only request an RIE instead of conducting a PAI or PLI if the Agency were unable to perform the PAI or PLI.”

ACRO similarly weighed in with supportive comments overall. “ACRO thanks the agency for the flexibility and expansion of FDA tools to enable evaluation of facilities during the COVID-19 pandemic.”

AAM and PhRMA want more clarity on written observations

Both PhRMA and AAM said there is a need to clarify provisions in the guidance related to closeout meetings. Both groups said FDA should clarify in the final guidance that it will provide a list of written observations at these meetings.

AAM stated that FDA should make clear that personnel should “make every reasonable effort to discuss all observations and potential observations with the facility prior to the closeout meeting.”

PhRMA concurred and stated that FDA should “always aim to provide a written list of observations, if any, following the closeout of an RIE.”

Clarity on RIEs

In other areas, AAM said FDA needs to clarify when it will request an RIE instead of conducting a PAI or PLI, or a follow-up inspection.

The group said that although the draft guidance contains “helpful” information regarding the circumstances under which FDA might request and conduct an RIE in these circumstances, the group claims there are “certain ambiguities” in the draft guidance that “warrant further clarification.”

Guidance consolidation

PhRMA further recommended that FDA consolidate the RIE guidance with other guidances on remote inspections, including FDA’s guidance on “Conducting Remote Regulatory Assessments Questions and Answers” and its “Draft Guidance for Industry; and Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications.” The group stated that “one document would minimize confusion among stakeholders.

Comments

Industry groups seek changes to FDA’s remote interactive evaluation guidance

Related topics

Recommended content

Welcome to the new RAPS Digital Experience