Kevin Stawicki, Law360, November 12, 2019.
The U.S. Food and Drug Administration is taking heat from prominent lawmakers over a special approval pathway for health software products sold by Apple, Samsung and other major tech companies, opening the door to a congressional showdown over whether the agency has the right to start such a program.
The FDA has spent two years working with nine tech giants and health companies to test a new approval route for rapidly evolving health software such as artificial intelligence applications to make treatment plans, calculate heart rates and track insulin levels. In addition to Apple Inc. and Samsung Electronics Co. Ltd., participating companies include Fitbit Inc., Johnson & Johnson and Roche Diagnostics Corp.
But lawmakers and legal experts have increasingly complained that the pilot program is shrouded in secrecy. In an Oct. 30 letter, several Democratic senators — including presidential contender Elizabeth Warren of Massachusetts and Assistant Democratic Leader Patty Murray of Washington — asked the FDA whether streamlined approvals are turning Americans into guinea pigs.
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The pilot program is called Digital Health Software Precertification, or simply Pre-Cert. It covers digital health products, such as mobile medical apps, that generally fall outside the agency’s traditional approval pathways.
A key component of the pilot program is known as an “excellence appraisal.” If a company undergoes the appraisal and is deemed a reliable producer of safe, high-quality software, it becomes eligible for streamlined approvals.
But what the appraisal process looks like in practice is an open question. The agency lists product safety, proactive culture, clinical and cybersecurity responsibility as the model’s main categories and insists that there should be “flexibility in the specific mechanisms by which excellence can be demonstrated.”
In a 2018 letter, the senators were among the first to ask the FDA what that flexibility entails. The agency in June replied with a 19-page letter, but the senators apparently weren’t satisfied, responding with 10 pages of additional questions and requests in their Oct. 30 follow-up.
“The agency stated that it is ‘exploring what types of data are appropriate to demonstrate excellence,'” the senators said, adding that the agency made no attempt to “provide any additional detail on the data or evidence it used to determine companies’ adherence to the excellence principles.”
The senators aren’t alone in demanding more details.
“When it comes to medical devices, anything that’s subjective results in very low standards,” Diana Zuckerman, president of the National Center for Health Research, told Law360.
“You have this idea of precertifying companies on the basis of somebody deciding they have confidence about the company’s standards,” Zuckerman said. “But we know from experience that many times prestigious companies have covered up information about risks of their products.”
Some big-name companies that aren’t participating in the pilot program have said the metrics need work.
Lisa Bollinger, a vice president at biotech Amgen Inc., told the FDA in a letter last year, “It is not clear how an organization can demonstrate consistent, adequate evidence generation for clinical effectiveness based on the proposed appraisal elements for pre-certification.”
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