FDA has released a list of nominations to its “Demonstrably Difficult to
Compound” (DDC) list, which is supposed to identify drugs that cannot safely be
compounded because of their complexity. Included on this list are certain kinds
of safe, bioidentical hormones such as progesterone (including progesterone
with estradiol), human chorionic gonadotropin (HCG), testosterone, and delivery systems such as time-released medicines. If these are
banned, drug companies would then have a government-enforced monopoly—even
though the pharmaceutical versions or their alternative products are often
substandard or even dangerous.
pharmacists say these are not difficult to compound and are not dangerous.
Thirty-eight percent of the nominations came from one of the largest
multinational pharmaceutical companies in the world. Other nominations came
from doctors with ties to Big Pharma, while some nominations seem to be from
people confused about compounding.
Eliminating time-released medicines also threatens people with certain conditions, such as hypothyroidism. These patients MUST have access to compounded hypothyroid medications, especially since pharmaceutical companies are starting to put gluten in their thyroid hormone medications, which will make the majority of these patients even sicker! Many people's hypothyroidism is caused by Hashimoto's disease, an autoimmune condition that would be exacerbated by gluten.
The FDA may deny the public any input on this list. Tell
the FDA to follow the rules and issue a proposed rulemaking, which allows for a
period of public comment, before finalizing its Demonstrably Difficult to
Compound list. Also tell them how important the survival of these compounded
drugs is for you.
personalize and add your own comments if you have time!
Please Issue a Proposed Rulemaking on the DDC List
Dear [Decision Maker],
Sincerely,[Your Name] [Your Address] [City, State ZIP]