FDA: Pharmacies Can Still Make Preterm Birth Drug

This is important to so many moms and babies, it’s difficult to calculate.  This WebMD article announces the Food and Drug Administration’s agreement to allow women at risk for preterm birth (ie have had a previous preterm birth) to continue to receive shots of 17-Hydroxyprogesterone from compounding pharmacies for 15 to 20 bucks a pop.  The price of medicine had been set to increase to $1,500 because the FDA had approved KV Parmaceutical version – Makena –  and women using the compounding version would be forced to take the KV version.

This news caused many women taking weekly shots of  17 OHP to go into a full-on panic, and rightly so.  They are trying to keep their babies alive, for goodness’ sake.  They are trying to keep their babies in the womb, where they belong.  They simply want their little ones to bake for as long as possible, so they will be born well and healthy, and now the FDA was going to force them to do a staggering financial calculation for something that had been costing them about the same amount as a couple of cups of Starbucks?

WTH?

I had one friend, in particular, who went into a spiral of panic.  When we last spoke, she was at 24 weeks gestation (Pea in the Podcast).  We call that the week of viability, because a baby *can* survive outside the womb, but likely won’t (roughly 3% survive).  Even if they do, they likely face a lifetime of challenges.  According to the March of Dimes…

Premature birth is a serious health problem. Premature babies are at increased risk for newborn health complications, such as breathing problems, and even death. Most premature babies require care in a newborn intensive care unit (NICU), which has specialized medical staff and equipment that can deal with the multiple problems faced by premature infants.

Premature babies also face an increased risk of lasting disabilities, such as mental retardation, learning and behavioral problems, cerebral palsy, lung problems and vision and hearing loss. Two recent studies suggest that premature babies may be at increased risk of symptoms associated with autism (social, behavioral and speech problems) (2, 3). Studies also suggest that babies born very prematurely may be at increased risk of certain adult health problems, such as diabetes, high blood pressure and heart disease (4).

If we’re going to talk about financial costs, as is inevitable, since KV Pharmaceutical has forced us to, the cost of prematurity to children, parents and society are incredible.  If this could all be avoided by a simple $20 shot from a compounding pharmacy, how in the world does it make sense to switch moms to a $1,500 FDA approved version?

It doesn’t.  That’s why the FDA has decided to look the other way.

Thank God.

-Bonnie