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.

Birth news

Yipes! That was a long hiatus! So sorry. Hope not to do that again.

I am back on Birth Story with huge new respect for teachers, after serving winter quarter as an undergraduate lab instructor at Northwestern University's Medill School of Journalism. What teachers do in the classroom, I discovered, is the tip of the iceberg of the job.

I am back. Yes! So back to our topic, sort of. Well, a tangent, actually.

Nearly every time I Google "birth news" looking for, you know, something to blog about — my topic is birth — I come up with some permutation on the "birther" flap calling for President Obama to produce (on a daily basis, as far as I can tell) his birth certificate. Otherwise, critics will assume he was born in Kenya, his father's country of origin.

Barack Obama

Is he? Or isn't he?

Donald Trump and Whoopi Goldberg got into a dustup on "The View" last week about Obama's alleged reluctance to produce his birth certificate. (Just Google "birth news.")

The next day, "The View" ladies showed what they said was a copy of Obama's birth certificate.

Ben Smith at Politico wrote yesterday that the document Trump claimed was his own birth certificate, produced to needle the President, is not in fact Trump's official birth certificate. (But then Trump did come up with the right one.)

All of which just tells you that you can't go wrong, publicity-wise, getting a corner of this issue, or non-issue, as the case may be. Maybe I'll get a lot more hits today than I do ordinarily, writing about boring old childbirth.

The Arizona legislature is considering legislation that would require the state to sign off on proof of U.S. birth from presidential candidates. (They wouldn't let me teach at Medill until I produced proof of U.S. birth. Surely presidential candidates don't get a pass on that.)

The House version of the Arizona bill calls for evidence that that baby dropped onto U.S. soil, while the Senate version of the bill includes a definition of a "natural" U.S. birth as one to individuals who were U.S. citizens at the time.

I think both those elements have to be there, actually. That is, proof of either of those things ought to be enough, and I think maybe we need some laws to clarify that.

Even though some people go to great lengths to manipulate the law to convey U.S. citizenship to their infants like, allegedly, the Chinese women Jennifer Medina writes about in the New York Times today, it is important for anyone born in the United States to be an "automatic" citizen. Anything else is a total repudiation of what the United States has been, and stood for, for more than two centuries.

At the same time, we live in a small world. Pregnant U.S. citizens travel all the time for work and pleasure, and probably some other reasons, too, and they shouldn't be terrified about losing their children's full rights of citizenship if they happen to be abroad when their water breaks.

The Administration and numerous officials of the state of Hawaii, where Obama was by all accounts born on Aug. 4, 1961, have repeatedly confirmed the President's birth to a U.S. citizen on U.S. soil. Two for two. (So that's settled, right?)

And whatever you think of Barack Obama, he is a stellar example of the promise the United States has made to its residents, going even beyond its citizens — that if you work hard, the sky is the limit on what you can achieve.

Well, that's my two cents for today. It's nice to be back, although like teaching, blogging is a whole lot more time-consuming than I thought it would be before I actually tried it.

Happy spring, dear reader!