[Ip-health] Note on use of Orphan Drug Act to increase price of hydroxyprogesterone caproate from $10 to $1, 500 per dose

Jamie Love james.love at keionline.org
Wed Mar 23 11:04:10 PDT 2011

On Wed, Mar 23, 2011 at 1:49 PM, Ruth Lopert <ruth.lopert at gmail.com> wrote:
> Well it would have to have been wouldnt it - isnt that part of the
> definition? The question is what was the basis of the estimate used?

Makena was first named Gestiva.    The following is from an earlier
news story about the drug.


KV Pharmaceutical Company And Hologic, Inc. Announces Resubmission To
New Drug Application For Gestiva
Tuesday, 13 Jul 2010 12:13pm EDT

If approved, Gestiva, commonly referred to as 17P, would be the first
and only FDA approved drug for the prevention of preterm birth in
women who are pregnant with a single baby and have spontaneously
delivered a single baby preterm in the past. As previously announced,
K-V has an agreement with Hologic, Inc. to secure the rights of
Gestiva upon FDA approval. About Preterm Birth According to the March
of Dimes, preterm birth, or the birth of a baby prior to 37 completed
weeks of pregnancy, affects one in eight babies born in the United
States. Additionally, the rate of preterm birth has increased more
than 35% in the last 25 years, and is the leading cause for infant
mortality and morbidity. Preterm birth is currently the number one
cause of neonatal mortality, and babies born preterm tend to grow more
slowly, have more problems with their eyes, ears, breathing and
nervous system, and experience more learning and behavioral problems.
Preterm birth has been estimated to cost the United States more than
$26 billion a year.

James Love.  Knowledge Ecology International
http://www.keionline.org, +1.202.332.2670, US Mobile: +1.202.361.3040,
Geneva Mobile: +41.76.413.6584, efax: +1.888.245.3140.

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