Stakeholders ask for more details in FDA’s IT, customer service strategies

Stakeholders want the US Food and Drug Administration (FDA) to provide more detail about its information technology and user experience strategies. They would also like to see a more centralized approach to implementing the strategies to avoid duplicative or incompatible efforts by the agency’s product centers.

In June, FDA sought comments on its information technology (IT) and customer experience (CX) strategies based on its Prescription Drug User Fee Amendment (PDUFA) and Biosimilar User Fee Amendment (BsUFA) commitments. Under the 2022 Food and Drug Omnibus Reform Act (FDORA), the agency was also mandated to publish its proposed strategies and get stakeholder feedback.

Several stakeholders, including the Pharmaceutical Research and Manufacturers of America (PhRMA), responded, requesting more details and discussions about the strategies. PhRMA also noted that it thinks the proposed strategies may fall short of what lawmakers asked of FDA in FDORA, including specific activities, priorities, milestones, metrics, and performance measures.

PhRMA addressed several questions from FDA, such as how its proposed IT strategy could benefit stakeholders. The group said it could help expedite drug developments and enhance lifecycle management across regulatory regimes.

"The IT Strategy could help enhance global harmonization, streamline the drug development process, reduce the time to product registration globally, and improve the burden that sponsors face in managing numerous unstructured and non-standardized filing details across the regulatory lifecycle of a drug," said PhRMA. "Accelerating cloud adoption, adoption of advanced analytics, adoption of global data standards, and ensuring global harmonization will help achieve this goal."

Furthermore, the group said cloud technology could allow for more seamless dynamic data exchange and review among multiple stakeholders, improving regulatory review processes across borders.

PhRMA also noted several issues not covered in the IT strategy that it would like to see included, such as international collaboration efforts and harmonization across agency product centers. Conversely, it also said that the proposed IT strategy could unnecessarily diverge from other global regulatory initiatives, negatively impacting the industry.

"As FDA implements the IT Strategy and IT Operating Plan, we recommend that the agency take measures to help ensure implementation is aligned and harmonized with other global regulatory initiatives, as appropriate and to the extent possible,” said PhRMA. “A similar approach should be taken to ensure consistency in interpretation and implementation of the IT Strategy across the agency."

Booz Allen Hamilton, a government contractor that often works with FDA, said a potential gap in FDA's IT strategy is how it measures, captures, and communicates its IT progress. It notes that the agency has listed certain metrics, but it's unclear how those metrics will follow its progress and how it can identify any ongoing issues with the strategy.

"Broadly speaking, the metrics are very high level and may not reflect customer sentiment at the strategic initiative level," said Booz Allen Hamilton. "At the strategic initiative level, metrics such as adoption, may not tell the full story."

Booz Allen Hamilton also noted a common theme in its IT strategy goals to centralize its technology investments. The organization said the strategy could help free up resources so the individual centers could focus on business issues, and the different centers could work through the Office of Digital Transformation (ODT) to address their technology needs. It, however, also cautioned that ODT should avoid using a heavy hand with the centers and instead work collaboratively to figure out their common needs and what can be reasonably implemented.

"Adding metrics associated with requirements coverage, budget and schedule and as well as measuring customer satisfaction using Net Promoter Score (NPS) would provide greater, more granular visibility into successes and offer valuable insights into potential improvement opportunities," the organization added.

Regarding the FDA's CX strategy, PhRMA lauded the agency for proposing to leverage artificial intelligence (AI), modernize interfaces, and invest in new technologies, which could help reduce inefficiencies.

"PhRMA is also encouraged by Goal 3, Promoting a Customer Focused Culture, and the inclusion of issuing a CX/UX roadmap and customer experience page to document accomplishments,” said the group. “An annually updated roadmap will be beneficial for better understanding the agency’s planned improvements and progress towards those plans.”

“PhRMA also suggests that FDA explicitly recognize regulators from other countries as one of its customers in the CX Strategy,” the group added. “Collaborating with agencies in other regions is critically important for FDA as we move toward a more modernized submission and regulatory review environment.”

Booz Allen Hamilton also commented on the issue and lauded the agency for its work to centralize and reduce siloes when it comes to its CX strategy. The organization noted that FDA interacts with a wide range of stakeholders with specific regulatory and information needs and encouraged the agency to conduct stakeholder interviews to identify metrics for success.

"As part of their analysis FDA could consider population-based scenario exercises to determine which communications channels apply to each population and where there are overlapping needs," said Booze Allen Hamilton.

"A successful Omni-channel experience would allow stakeholders to engage with FDA through many touchpoints across any channel that is most convenient to the stakeholder that also seamlessly connect to vital public health information," the organization added. "FDA’s future user of technology can utilize AI as part of an automated comms plan that uses intelligence to identify impacted populations and predict the appropriate campaigns targeted to those populations."

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Stakeholders ask for more details in FDA’s IT, customer service strategies

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