Pricey drug that prevents preterm delivery angers patients and doctors
7:12 PM, Mar 16, 2011
A drug that prevents preterm delivery has the potential to spare
10,000 babies from an early arrival each year.
It was recently approved by the Food and Drug Administration,
and while that gives more doctors access to the drug, the new price
is actually shutting women out.
Lauren Fleming celebrated her 7th birthday last month, a day her
parents worried would never come.
Lauren was born three-and-a-half months early.
"She had multiple surgeries, while she was in the NICU, she
spent roughly 5 months in the NICU," recalls mother Nikki
She still has some medical problems linked to her premature
birth, but is otherwise healthy and now a big sister thanks to a
drug Nikki's doctor prescribed.
"He informed me that should we get pregnant again we would have
to have progesterone injections to prevent a subsequent premature
birth," Nikki says.
Progesterone injections have been recommended for women at risk
of premature delivery since 2004.
Until recently the shots were available from compounding
Recently the FDA gave KV Pharmaceuticals the exclusive rights to
produce the drug, called Makena, something the March of Dimes
"It's important that drugs that are used by the public are
approved by the FDA," says March of Dimes medical director Dr. Alan
What they don't support is the new price.
The shots used to cost $10 each.
Now KV pharmaceuticals plans to charge $1,500 per dose, an
estimated $30,000 per pregnancy.
"We were surprised, we think its too high," Fleischman says.
The manufacturer says the cost is justified to avoid the mental
and physical disabilities linked to prematurity and promises that
every woman who needs the drug will get it through the company's
patient assistance program.
Yet some doctors fear even with financial help the cost for some
women will be insurmountable.
Moms say a healthy family shouldn't have a price tag.
"I have two full term pregnancies as a result of this drug and I
just want more women to be able to have this drug available to
them," says Nikki Fleming.