Kyle Faget Comments on Legal, Regulatory Implications of Telehealth Prescribing Restrictions
Foley & Lardner LLP partner Kyle Faget shared insight in two Inside Telehealth articles on the legal and regulatory implications of restricting access via telehealth to the drug mifepristone.
In the first article, Faget explained that shield laws “protect the practitioners in the states that are where it’s legal to prescribe mifepristone and will allow those prescribers and protect those prescribers from prescribing across state lines.”
“If you institute an in-person requirement for access to mifepristone, you cut off telehealth access to mifepristone, for example, and ultimately could undermine some of these state efforts to invoke shield laws,” she continued.
In the second article, Faget noted the U.S. Department of Justice’s recent call to dismiss a lawsuit in Texas restricting telehealth access to mifepristone and the potential implications of the DOJ revisiting historical decision made by the U.S. Food and Drug Administration.
“If you hold that that is true in this context,” she commented, “you absolutely open the flood gates for litigation for any other product that’s approved by FDA that has adverse events. Where do you meaningfully draw the line?”
“There’s this fine line happening here where FDA is being expected to and called upon to weigh in on the standards of care, where FDA actual job is to weigh in on safety and effectiveness,” Faget added.
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