Birth & Parenting News: Drugs to Prevent Prematurity

Recently, there has been some dramatic and newsworthy changes in the marketing of drugs to prevent premature birth.

First, the FDA gives strictest warning for the drug Terbutaline, which has been used for decades.

Second, pregnant women will still be able to get a drastically cheaper version of a new expensive drug that prevents premature birth. Since the drug was approved, it’s been unclear whether women would have to pay $1,500 per dose for the licensed version or could continue to have it made by specialty pharmacies for $10 to $20 per dose. The recent price increase caused an outcry, prompting the FDA to take the unusual step of declaring that pharmacies can still make the cheap version of the once-a-week shot on an individual basis, as they have for years. The agency said it wouldn’t step in unless there was a problem with the safety of the specially made version.

Last month, the American College of Obstetricians and Gynecologists, along with the American Academy of Pediatrics and the Society for Maternal-Fetal Medicine, urged the drug’s manufacturer, Ther-Rx Corporation, to reconsider its pricing of Makena, arguing that the extremely high cost will hinder access to the treatment for both insured and uninsured patients.

Doctors and others welcomed the new drug because it would be easier to get and mean more consistent quality, but were stunned when the $1,500 per dose price was announced. Total cost during a pregnancy could be as much as $30,000.

The FDA does not control pharmaceutical pricing. The company said the price was justified because very premature infants need months of intensive care and often suffer disabilities, and because it spent millions bringing the drug to market. Last month, the company sent a letter to special pharmacies across the country, warning them to stop making the cheaper version or they would face FDA enforcement. An FDA spokeswoman initially said the company’s letter was accurate. However, the FDA has become increasingly aware of public worry and anger over whether women would still be able to get the drug, and whether state Medicaid programs that serve the poor would still be able to pay for it, federal officials said.

“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 the drug, also known as 17P, the statement said.

Makena is a synthetic form of the hormone progesterone. An earlier version first came on the market more than 50 years ago to treat other problems; it was withdrawn in the 1990s, though not for safety reasons. The drug got a new life in 2003, when a study showed it helps prevent premature birth in women who previously delivered early. Doctors started prescribing it, and pharmacies mixed it.

Each Wednesday, our Birth & Parenting News blog highlights the latest news items, research results, consumer alerts, and legislative action alerts of interest to expectant and new parents and the professionals who work them.

Posted by Patty Brennan on April 27, 2011 • Filed under Birth & Parenting News
Comments (0)

Comments