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KV Pharmaceutical manufactures Makena, a form of
progesterone prescribed for women with high-risk pregnancies to help prevent
pre-term births. Compounding pharmacies have been making a safer and far less
expensive version of the medicine for over a decade. Now KV has filed a
complaint with the International Trade Commission (ITC) in an attempt to stop
the supply of the ingredients for the compounded version. Since the entire
supply of its active ingredient is imported, this move would effectively keep
compounding pharmacies from making and selling this important medicine—and
would completely eliminate the competition.
One of the biggest factors is cost—Makena costs $30,000 per
pregnancy, while the compounded version costs only $200 per pregnancy.
Eliminating the compounded version would make the drug cost prohibitive for many,
many women. On top of that, the commercial drug contains the toxic preservative
benzyl alcohol, which has been linked to “gasping syndrome” in infants and, according
to the CDC, has caused six neonatal deaths. Doctors can prescribe a compounded
version of 17P without the benzyl alcohol, but if the ingredients are banned to
compounders, only the version with the benzyl alcohol is left.
Tell the ITC it is vital that compounding pharmacies be
allowed to continue importing the active ingredients for 17P. The comment
period ends this Friday, so please send your message today!
Please personalize your message if you have the time!
Please Deny KV Pharmaceutical's 337 Case to Ban 17P Ingredients!
Dear [Decision Maker],
Sincerely,[Your Name] [Your Address] [City, State ZIP]