‘Thanks For Calling The FDA. This Is A Computer’… AI Could Help Field Drug Safety Questions
Executive Summary
The agency is considering using artificial intelligence, including chat bots, to deal with telephone calls from the public about drug safety issues.
The US Food and Drug Administration is looking at ways a computer could help answer some of the drug safety questions it receives from the public.
Telephone calls remain the top method for lodging drug safety inquiries, according to data from recent Center for Drug Evaluation and Research Drug Safety Priorities reports, and the FDA is considering alternatives to humans answering them.
A team of pharmacists, nurses and other health professionals fields questions about human medications from consumers, providers, research organizations, drug companies, academics and others. In addition to the telephone, inquiries arrive via email, social media (namely Facebook and LinkedIn) and traditional mail, the 2022 CDER Drug Safety Priorities report says.
“We are moving in a direction for more self-service options, automation and even artificial intelligence features like chat bots” to manage telephone calls, the agency told the Pink Sheet.
Moving to AI to help manage phone calls, if implemented, seems at odds with the reason the FDA believes so many people call the agency to ask questions: They want human contact.
“People who pick up the phone to call the FDA need and want human help,” the agency said. “They have exhausted other electronic and human avenues to better understand a drug recall, drug shortage, adverse event or ask a drug question.”
Inquiries can be complex and the public need for responses require multiple ways to communicate, the FDA said. The agency added that the “full value and applications of automation are yet to be determined,” but are intended to compliment the existing system.
“Self service options, including phone trees or chat bots, would allow some individuals to find information more readily than having to speak with a pharmacist,” the agency said. “Self-service automation using robotic process automation (RPA) for routing callers combined with [customer relationship management] integration would be especially helpful in fielding commonly asked inquiries, communicating during public health emergencies, in cases when the matter is time sensitive, or directing inquirers to the proper resources when CDER is not the appropriate center to field their inquiry.”
Exploring AI to help deal with public inquiries coincides with the FDA considering its uses in drug development. CDER hopes the technology can improve its understanding of disease progression and treatment response in diverse patient populations and enhance precision medicine. (Also see "FDA’s CDER Is Fostering Use Of Artificial Intelligence In Drug Development" - Pink Sheet, 28 Feb, 2023.)
Email Being Used More Frequently
The FDA logs thousands of public inquiries related to drug safety each year. In fiscal year 2022, the agency received 45,813 inquiries, which was down 27.7% from FY 2020, but an increase from the estimate the agency gave for FY 2021. (See graph below.)
Public inquiries via telephone dropped 34.9% from FY 2020 to FY 2022, but still remained the most popular communications method. In FY 2020, nearly 66% of inquiries were phone calls, while in FY 2022, they were 59.4%.
The FDA expects the trend away from phone calls to continue. However, the agency said CDER is "responsive to our stakeholders’ individual needs and if the telephone is how they choose to communicate, we support that option as part of CDER’s mission to serve the public.”
Email has gained ground as a preferred communications method, increasing from 32% of public inquiries received in FY 2020 to 38.9% of inquiries in FY 2022. Somewhat surprisingly, social media remained largely a non-factor as a source of public inquiries. Facebook and LinkedIn were used for 1.4% of public inquiries in FY 2020 and only 1.2% in FY 2022. The FDA received .5% of questions via traditional letter in FY 2022, slightly lower than the .6% in FY 2020.
The Oncology Center of Excellence also takes phone calls from the public. OCE's Project Facilitate allows patients and providers to call for help navigating the expanded access pathway for cancer treatments. (Also see "When Expanded Access Also Means Off-Label Use, US FDA May Need New Policy" - Pink Sheet, 29 May, 2019.)
The story continues after the chart…
Inquiries On COVID-19 Subsiding
The subject of the public’s drug safety inquiries has shifted significantly in the last few years, influenced largely by the COVID-19 pandemic. Valsartan and nitrosamines were the subjects of the top inquiries in 2018 and 2019, but COVID-19 or coronavirus became the leading topic in 2020, 2021 and 2022.
However, the margin between COVID-19 and the second most popular inquiry shrunk between 2020 and 2022, suggesting the public became more knowledgeable about the disease, its treatments and vaccines. (See chart at the end of the story.)
In 2020 when the pandemic took hold, nearly 16,000 inquiries were received on the subject, 10,288 more than nitrosamines, which was the second most popular subject that year. By 2022, only 2,424 inquiries separated coronavirus from the next most popular question.
The topic that appeared most consistently among the top inquiries was opioids. The drugs were the No. 2 subject in the 2018 and 2019 reports, third in the 2020 report and second again in the 2021 report. Opioid inquiries were the fifth most popular in the 2022 report.
FDA officials are engaged in a wide-ranging campaign to stem opioid abuse, which may explain the consistent number of drug safety inquiries. An opioid prevention framework, its third drug abuse plan in six years, was released in August 2022. (Also see "‘Opioids’ Is Missing From The US FDA’s Overdose Prevention Framework Title On Purpose" - Pink Sheet, 13 Sep, 2022.) More recently, Commissioner Robert Califf has suggested labeling may be changed in an attempt to curb prescribing. (Also see "Califf Hints At Labeling Changes For Opioids And Chronic Pain" - Pink Sheet, 23 Feb, 2023.)