As Stem Cell Clinics Proliferate, E&C Leaders Seek to Hear FDA’s Plan

Regulatory NewsRegulatory News | 25 July 2019 |  By 

A bipartisan group of representatives on the Energy & Commerce (E&C) committee sent a letter to US Food and Drug Administration (FDA) Acting Commissioner Ned Sharpless on Thursday seeking more details on the agency’s plan to slow the proliferation of stem cell clinics.

While noting that FDA has agreed to exercise enforcement discretion for 36 months in a recent guidance, the letter also explains how CBER Director Peter Marks said in April that industry has shown “modest progress” in coming into compliance.

“We would like to better understand the FDA’s current strategy for monitoring the market and bringing these therapies into compliance. We would also like to understand the agency’s plans to implement a long-term enforcement strategy once this period comes to an end in November 2020,” Reps. Frank Pallone (D-NJ), Dianna DeGette (D-CT), Greg Walden (R-OR) and Fred Upton (R-MI)  wrote.

The letter praises FDA’s work so far in cracking down on some of the unscrupulous stem cell clinics, but also seeks further information on the meetings that CBER has had on stem cell products with sponsors and potential sponsors, how many FDA officials are monitoring the market for adverse events or safety signals and how FDA is coordinating with other federal and state officials, among other questions.

They also note how dubious stem cell treatments can undermine public confidence in legitimate regenerative medicine products and clinical trials.

“As we approach the halfway point in this period of FDA enforcement discretion, we want to register our concerns about the proliferation of unproven stem cell therapies on the market and our desires to ensure that the agency is doing everything in its power to protect patients,” the letter says.

Letter to FDA


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Tags: CBER, E&C, stem cell

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