Hey FDA, what’s your plan on DTE?

With an August 1 ban fast approaching and no patient transition of care plan from FDA, we need FDA enforcement discretion when it comes to compounded desiccated thyroid extract products.

That’s the message we sent to the agency in a letter earlier this month, knowing it’s grappling with whether and how to limit access to compounded DTE as the current enforcement-discretion period ends in a couple of weeks.

Despite what drugmakers are saying, “the practical reality is that these are not fringe therapies for the patients who depend on them,” we explained.

Practical reality. That’s our biggest point. Limiting or banning compounded DTE will mean patients will face a sudden disruption in their medication (and for many of them, there is no alternative therapy).

Pharmacies, prescribers, patients, manufacturers, suppliers, and state boards of pharmacy are already asking what happens next — and no one seems to know the answer.

There are already enough supply-chain and patient-access issues. The last thing we need is to have them worsen without a logical reason backed by evidence … and that puts patients’ needs front and center.