FDA Actions Signal Scrutiny of Telehealth Prescribing Models: Attorneys

Recent FDA enforcement activities could signal increased scrutiny of telehealth platforms that facilitate prescribing of compounded drugs, particularly when technology or standardized processes may undermine individualized clinical decision-making, according to attorneys at ArentFox Schiff.

In an 10/5 Insights post, attorneys Abha Kundi and Matthew Berlin noted FDA's 9/18 Warning Letter to Empower Pharmacy (see earlier story), a Houston compounder producing high volumes of compounded semaglutide and tirzepatide products containing additional ingredients such as niacinamide and vitamin B12.

FDA concluded the products were essentially copies of approved drugs and questioned whether formulation differences were genuinely based on individual patient needs. According to the attorneys, FDA found that prescriber statements used to justify the differences were repeated verbatim across numerous records and specifically cited third-party technology platforms offering prescribers “pre-selected menu options” as potentially inconsistent with individualized clinical judgment.

Kundi and Berlin said the letter should serve as a warning to telehealth companies that platform design itself could attract regulatory scrutiny if it appears to steer or standardize prescribing decisions.

“A small tweak does not make it legal,” the attorneys wrote, noting that adding an ingredient to a compounded drug does not automatically distinguish it from an FDA-approved product when the change is not supported by a legitimate patient-specific determination.

The attorneys also highlighted an 8/31 memorandum of understanding between FDA and the Securities and Exchange Commission that establishes procedures for more routine sharing of non-public information (see earlier story).

Although the agreement does not specifically address telehealth, Kundi and Berlin contend it could have implications for telehealth, biotech and other healthcare companies raising capital or communicating with investors. Regulatory information involving Warning Letters, inspections or compliance history could potentially be compared with representations companies make to investors. “The bottom line: your regulatory story and your investor story need to match,” they wrote.

The attorneys recommended that telehealth companies review whether their platforms preserve independent prescribing decisions and ensure that regulatory representations are consistent with disclosures made to investors.