The Food and Drug Administration’s most recent guidance on customized
natural medicine once again threatens to limit patient access to
important thyroid medications. The guidance document deals with natural
medicines that are “essentially copies of commercially available drugs.”
This refers to a medicine made by a pharmacist or doctor that has the
same active ingredient, dosage, and route of administration as a
pharmaceutical drug currently on the market.
The guidance strictly limits the quantity of these kinds of
medicines that can be prescribed. The FDA is essentially saying that copies or
near-copies of commercially available drugs cannot be compounded unless a doctor
writes a specific prescription noting how a specific change will benefit a
particular patient—and the FDA notes that this exception should rarely be used.
How rarely? The FDA says that it does not intend to take
action against a doctor or pharmacist if they fill four or fewer
prescriptions of the medicine in one month. Will the agency take action when
the number is five? Given this wording, it is likely.
These crazy rules could cause real harm to thyroid patients,
among many others. If the FDA determines that compounded thyroid hormones are
essentially copies of commercially available products like Cytomel or Synthroid,
doctors will only be able to write four or fewer prescriptions each month.
Write to the agency and urge them to maintain access to these medicines!
Maintain access to thyroid medicine
Dear [Decision Maker],
Sincerely,[Your Name] [Your Address] [City, State ZIP]