Here's a fable about the dangers of overreaching. A pharmaceutical company, armed with exclusive rights to an FDA-approved drug for pregnant women, figures it has a lock on the market. The drugmaker slaps a big price tag on that drug and puts it up for sale. At $1,500 a dose, the company stands to take in significant sales.
But then something happens that the drugmaker didn't count on. Those expectant mothers--and their doctors and government representatives--fight back. They were used to getting their doses at $10 to $15 each. The company tries to soothe the mother hens' ruffled feathers. It offers help paying for the drug to any mother who might need it. But these mothers and their doctors are too outraged. They paint a very unflattering picture of the company in the media. They pressure this company to cut its price, but the company resists.
Then, FDA jumps into the fray. The agency doesn't have the power to tell this company--a.k.a. KV Pharmaceuticals--to lower the price. But it can allow compounding pharmacists to keep on making their version of the new, expensive drug, and sell it at its old, much-more-affordable price. And that's just what the FDA does, with an official statement released Wednesday morning.
"FDA understands that the manufacturer of Makena, KV Pharmaceuticals, has sent letters to pharmacists indicating that FDA will no longer exercise enforcement discretion with regard to compounded versions of Makena," the agency said in a statement. "This is not correct."
Whether KV will now decide to slash its retail price on Makena, which is designed to prevent premature births, remains to be seen. At press time, the company had not commented on FDA's decision. In an earlier statement, KV said it's committed to ensuring that Makena "is accessible to all women who are prescribed Makena and will address the concerns raised," the St. Louis Post-Dispatch reports. But the moral of this story is clear: Sometimes, ambitious drugmakers will find their reach exceeds their grasp.