FDA Will Allow Cheaper Version of Pregnancy Drug to Be Sold

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Following the uproar over the pricing of a drug to prevent premature birth — which went from about $10 per dose to $1,500 after the FDA approved a branded product to replace an older, unapproved version — the agency said today that it will not enforce action against makers of the cheaper drug.

The new drug, Makena, is a form of progesterone known as 17P that has been legally sold by compounding pharmacies for decades. The older version was approved more than 40 years ago, before the FDA required proof of both safety and efficacy for approval (17P was deemed safe).

(More on TIME.com: Can Patients Get Around Exorbitant Cost of Pregnancy Drug?)

But after research found that 17P is also effective at reducing the risk of premature birth, by about one-third, the FDA approved Makena so that a consistent dose and formulation of the drug would be available. The compounded versions of the drug that doctors had been using were made by individual pharmacies — these versions can vary in quality more than branded or generic drugs.

In a statement in response to a query on enforcement raised by Senator Sherrod Brown (D-Ohio), the FDA said: “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. This is not correct.”

(More on TIME.com: Outrage over Pregnancy Drug Price Hike May Force Change)

To put that in English: the FDA will allow the cheaper version of the drug to be sold. Said Brown in a new statement, “FDA’s announcement is a victory for pregnant women, consumers, and taxpayers. This drug, which was developed with extensive taxpayer support, is too important to fall out of reach for pregnant women.”

Reuters reports that shares of KV fell by nearly one-third on the news.

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