FDA Meets With Clinical Decision Support Firms To Address Challenging Cases
This article was originally published in The Pink Sheet Daily
Executive Summary
The agency recently sat down with members of the Clinical Decision Support Coalition who presented mock case studies of regulatory submissions for software supporting drug therapy decisions. The coalition hopes to get feedback on how FDA intends to regulate such software in the coming months.
The Clinical Decision Support Coalition met with officials from FDA's Office of Combination Products recently to present ten "mock-use" submissions for software linked to drug therapy decisions that have raised complicated regulatory questions for member companies.
The discussion was aimed at helping the agency better understand the challenges manufacturers face in developing clinical decision support (CDS) tools, particularly software to support drug delivery. The CDS Coalition is hoping the exercise will lead to more clarification on how the agency intends to regulate such products.
Companies have been struggling to understand FDA's regulatory intent, especially in cases involving drug-delivery CDS tools, so they created the mock-use cases to elicit more feedback.
FDA has published guidance documents and statements signaling its plans for a risk-based approach to regulating mobile health software including CDS. A draft guidance in development to address medical device decision support software is on the agency device center's top priority list for fiscal year 2016. (Also see "CDRH Guidance Priorities Include Lab-Developed Tests, Adverse Event Reporting, Third-Party 510(k) Review" - Medtech Insight, 29 Dec, 2015.).
However, Bradley Thompson, general counsel for the CDS Coalition and an attorney with the law firm Epstein Becker & Green, said that his member companies have been struggling to understand FDA's regulatory intent, especially in cases involving drug-delivery CDS, so they created the mock-use cases to elicit more feedback.
The coalition met with agency officials including Thinh Nguyen, director of the Office of Combination Products, on Feb. 5. Thompson described gathering as "like a mock pre-submission meeting." He says the agency officials asked many detailed questions about the cases, but said they needed more time to figure out how to categorize each case.
"I'm thinking it may be a couple of months for them to have all the discussion they need to have and we might hear some feedback from them on how these use cases might be regulated," Thompson said.
The coalition drafted the mock cases based on real submissions from members and presented "de-identified" versions of the submissions to FDA.
One example of a CDS use case that was presented is a software tool a hospital pharmacist could use to determine accurate dosing and be alerted for drug-drug interactions.
"Some dosage calculations are really, really simple; it's multiplying three or four numbers together," Thompson explained. "Some are much more complicated because they involve genetic information, and so forth, to figure out proper dosage."
Other areas the CDS use cases touched on were applications to determine proper drug selection and drug management based on patient response to a therapy, helping clinicians determine the optimal dosage over time.
The goal in each case is to try to understand if the agency will regulate the product as a device or combination product, and if there's a drug-labeling issue.
Not Linked To CDS Guidance
Thompson says the coalition is not interested in having its use cases included in the upcoming CDS draft guidance. He estimates it takes about four years for FDA to release a guidance, and adding this new element could delay the document.
"I explicitly told them, from my standpoint, I did not want to suggest that they wait … to address these questions in that CDS guidance because I knew that would slow down that guidance," he said. "It covers an awful lot of topics. I don't think [the guidance is] written to be very focused on the pharmaceutical case studies. I think it's more typical of what you'd see in an electronic health record for data analysis."
The coalition has been meeting with FDA regularly over the past several years to discuss the broader CDS guidance, but this is the first time they've talked specifically about CDS tools for drug delivery.
FDA acknowledged that the meeting took place, but would not comment on the substance or impact of the discussion.
"We do appreciate [the CDS Coalition's] input and will take it into consideration as we develop our policies and approaches, just like we would for any stakeholder meeting," FDA spokesperson Angela Stark said.
[Editor's note: This article was first published in "The Gray Sheet," which provides in-depth coverage of medical technology issues. "The Pink Sheet" DAILY brings selected complementary coverage from sister publications to subscribers.]