Friday, April 1, 2011

Major Drama in Preemie-land

Not with Bryce, thankfully -- our little squeaker is doing fantastic. We enjoyed a healthy spell from mid-February to mid-March, and when he did catch a cold near the end of March he weathered it better than Logan! He's got nearly a full mouth of teeth and a good appetite to go with them. His speech has regressed over the past six weeks to the point where we rarely get more than a whine or a cry these days, but considering how well he's doing in all other areas (including receptive language), we're confident that he'll talk when he's ready. Finally, we're gearing up for the 2011 March for Babies on May 1st : if you'd like to enjoy a walk in the park for a great cause, please join us!

The drama that I'm referring to centers around a little shot known as 17P. This drug, which is provided to women with a history of premature labor, has helped many carry subsequent babies to term. The shot, which must be given weekly from about 17 weeks onward, was available from many "compounding pharmacies" at a cost of about $10 per shot.

In swoops KV Pharmaceuticals. With the support of the FDA and the March of Dimes, KV Pharmaceuticals won the right to become the exclusive provider of 17P, which they rebranded Makena. Why? To ensure a "standard concentration" of all 17P. As soon as their exclusive rights were announced, KV Pharmaceuticals promptly sent cease and desist notices to all other manufacturers and announced that they would be raising the price to $1500 per shot. No, that is not a typo -- $1500 per shot.

Naturally, the community of preemie parents has been in an uproar. The increase in price will inevitably make it much more difficult to get insurers to pay for the drug, because a treatment that once cost $200, and had the potential to prevent the average $50,000 cost of premature birth, now costs $30,000. Even those insurers that will still cover it will be forced to pay an outrageous premium for the privilege of filling the coffers of KV Pharmaceuticals.

The March of Dimes response was tepid at first, but thanks in no small part to some heartfelt and thoughtful appeals from other preemie parents (e.g, here), I'm somewhat mollified to see that the March of Dimes terminated their relationship with KV Pharmaceuticals (a million $+ sponsor) effective today. Furthermore, I was tickled pink to see that the FDA effectively flipped the bird to KV Pharmaceuticals when they announced on Wednesday that they have no intention of enforcing the exclusivity rights of KV Pharmaceuticals.

Score one for the good guys.

UPDATE: Makena hits the mainstream news.

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