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I learned last Thursday that an affordable, safe, and lifesaving treatment for preterm labor called 17P has been monopolized by a pharmaceutical company (KV/Ther-RX under the drug name Makena) and will result in an price increase of 1500% .
In other words, what is currently costing patients $200 for an entire pregnancy's worth of drugs will now cost the $30,000!!! 17P has been around for over 40 years and was produced safely by compounding pharmacies. It’s been affordable and accessible and research was publicly funded by the NIH in 2003.
The argument by the KV Pharm, the drug company is that it will now be safer and more consistent since it has FDA approval. The only problem with this is that “orphan drug” status was granted which removes all competition and this one company is monopolizing this product to a desperate patient population. KV did not invent this drug and it had previously been proven safe and effective by the NIH so it's unlikely that KV spent much money on research and development.
In response to the public outcry last week, KV announced a patient assistance program which claims they will not deny coverage to those who cannot financially afford it but when you read the strict restrictions on who would qualify, it's clear that next to no one will qualify under their terms.
It’s absurd to even need an assistance program for a drug that everyone could afford last week. Even if patients are covered by insurance for it, it makes no sense that health insurance companies and Medicaid should face such price gouging either. This will only cause premium costs to rise for everyone.
Since the FDA has already granted the “orphan drug” status, it’s unlikely they would be willing or able to revoke that. The best answer now is for our lawmakers to pass a law exempting 17P from "orphan drug" status. Without this the number of children being born premature is sure to rise dramatically and many children will not survive and those that do will face a lifetime of disabilities.
Aside from the human cost, the financial cost will be outrageous. $200 in drugs during pregnancy could save millions in NICU care and the costs associated with lifetime care for those with disabilities. Now it’s being taken away from those who need it, is it any wonder our health care system is in trouble? The American Academy of Pediatrics, The American College of Obstetricians & Gynecologists, as well as the Society for Maternal Fetal Medicine are speaking out against this: http://library.constantcontact.com/download/get/file/1102667451069-188/20110311GoedekeLtr.pdf
We cannot allow this to happen. I respectfully request that you introduce a law exempting 17P from "orphan drug" status.