FDA Correspondence

In 2012, Empire State Consumer Project, with the assistance of two remarkable women Jeanie and Carol wrote a petition to the FDA asking the FDA to look into the safety of polyethylene glycol (PEG) 3350 in children. PEG 3350 happens to be the only ingredient in the over the counter laxative MiraLAX which is commonly used off label to treat constipation in children. This would spur many back and forth emails;

An email from the FDA in 2019(1) detailed the history of MiraLAX from when it came to the market in 1999 to where we are at today. I think it’s important to pay attention to the fact that PREA (pediatric research equity act) was triggered, which should have held the manufacturer responsible for conducting pediatric studies, which the FDA initially deferred for ten (10) years when MiraLAX came over the counter in 2006. This language is in the approval letter, signed by the FDA and the manufacturer! On October 30, 2000, the FDA issued final regulations implementing that law (65 FR 64607). The regulations went into effect on April 30, 2001 (66 FR 10815), and FDA issued a draft guidance related to the rule in April 2001; which should have required the manufacturer to conduct the postmarketing studies. 

However, the FDA went on to waive the required studies(2) only to circle back and “change their minds” requiring all new drugs containing polyethylene glycol 3350 to conduct the studies that were once required for MiraLAX. 

Upon receiving an email from the FDA in 2017(3), there was some excitement that the polyethylene glycol safety in children study would finally be completed. Twelve months later (4), the air was taken out of the sail and there is no definitive timeline. After hearing of some samples (5) provided to the FDA by the hospital in 2019, was a little bit of a head scratcher; according to the FDA email in 2017, the hospital had clinical testing of their assays in 2017 and would wrap up their testing in 2018. Why didn’t the FDA receive the samples until 2019?

Unfortunately the grant expired in 2019 (6), however the FDA seems committed to fund this work until it is completed (7). Unfortunately, the hospital and the FDA have been pretty quiet and have only sent subtle responses to any emails since 2020. The tentative completion date is June 2024, however the trial still appears to be in the recruiting phase. We will see if the study is completed here in the coming months.