The hormone progesterone has been used during pregnancy for I don’t know how many years to help prevent preterm labor. It was a possibility that I would need it during my pregnancy with Ian, but because my cerclage was holding things together, I did not receive these weekly shots. However, my peri and I have discussed that I will definitely need these shots in future pregnancies because I went into preterm labor with Ian.
This drug has been around for ages. Recently, KV Pharmaceuticals obtained FDA approval to use this shot for preterm labor prevention, a move which was supported by the March of Dimes and many doctors because FDA approval would mean that the drug would be regulated, which should increase the safety of the drug’s production.
Upon receiving this FDA approval, KV Pharmaceuticals increased the price of the P17 shots. From $10 per shot to $1500 per shot. Now that they’re the only company who can sell it, there’s no other option for people who need it. If we’re lucky, insurance will cover it. If we’re not lucky, KV Pharmaceuticals says they won’t deny it to anyone who can’t afford it. In my opinion, that doesn’t make it okay. And if our insurance will cover it, they have to pay for it somehow, which means somebody’s premiums are going up. Regardless of who pays for it, it’s going to increase costs for someone, and it means that my next pregnancy will cost an extra $30,000. The reason for the price increase? Who knows (aside from greed). It’s not like KV had to research or develop this drug.
I’m hoping that if enough people join in this outcry, something will be done to fix this. I copied this letter from another blog. If you would like to send a message to your congresspeople, please feel free to copy this letter.
I am writing you today to ask you to call for the P17 drug to be exempt from FDA Orphan status. KV Pharmaceuticals recently won Orphan status rights for this drug and will market it under the name Makena.
As you know Orphan drug status is a form of a grant given by the FDA to support the development of drugs for rare diseases affecting less than 200,000 people. This drug was already invented before KV Pharmaceuticals won rights to produce it. This drug came on the market more than 50 years ago for other purposes. A 2003 study brought new light to the drug when it was shown beneficial in preventing pre-term labor in those who had already had a previous case of pre-term labor.
The study showed a reduction in pre-term births from 55 percent to 36 percent. Currently the US averages 500,000 premature births per year.
By granting Orphan status to the drug, KV Pharmaceuticals has raised the price per dose from $10 to $1,500. This means that for a pregnancy, the price to take this drug would go from $200 to $30,000. As preterm labor affects 500,000 births a year, the increase in cost will undoubtedly mean less access to the drug, causing a higher preterm birth rate, straining the public health system and causing countless unnecessary suffering to our citizens.
Thank you for your time. I urge you and other members of Congress to call for the P17 drug to be exempt from FDA Orphan status.