FDA nixes monopoly on preterm-birth drug

The U.S. Food and Drug Administration on Wednesday took the unusual measure of saying it would allow pharmacists to continue to compound a drug after a new FDA-approved version of the drug debuted in February.

The drug in question is hydroxyprogesterone caproate, which has been around for decades, and has been shown to prevent preterm birth.

The FDA moved to make the drug available in an affordable mode, in light of the fact that the newly approved synthetic progestin, brand-named Makena, produced by KV Pharmaceutical, is going on the market at $1,500 a dose.

When pharmacies compound the "generic" form of the drug, also known as 17P, it typically costs $10 to $20 per dose, according to a press release from the Society for Maternal Fetal Medicine.

In the past, physicians could ask pharmacists to make up a batch of the sterile injectible. However, the FDA ordinarily forbids pharmacy compounding of a drug it has approved.

Indeed, KV Pharmaceutical reportedly sent letters to pharmacies indicating that the FDA would no longer tolerate pharmacy compounding of the drug.

"That is not correct," the FDA declared in its statement.

"In order to support access to this important drug, at this time and under this unique situation, FDA does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient" as long as the drug is compounded according to "appropriate standards," the statement said.

Drug companies often charge high prices for newly approved drugs to offset the expense of the typically costly, research-laden approval process.

However, KV Pharmaceutical "received considerable assistance from the federal government in connection with the development of Makena by relying on research funded by the National Institutes of Health to demonstrate the drug's effectiveness," the FDA statement said.

"It also obtained seven years of exclusivity under the Orphan Drug Act, obtained approval under FDA's accelerated approval program, and received expedited review," the statement said.

More on this tomorrow.

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