Tuesday, February 8, 2011

17P is approved by FDA

Update:  The company providing this drug plans to make a huge profit, charging 14,900 % of what it cost previously through compounding pharmacies.  There is no justification for this besides gouging and taking advantage of people who need it the most.  We cannot support March of Dimes due to their conflict of interest because they have received a lot of funding from the company KV  Pharmaceuticals.  They are clearly not putting people ahead of money.

FDA approval of 17P (March of Dimes - News Moms Need)

The first-ever drug known to prevent some preterm births won market approval today from the Food and Drug Administration. “For the first time, we have an FDA-approved treatment to offer women who have delivered a baby too soon, giving them hope that their next child will have a better chance at a healthy start in life,” said Alan Fleischman, MD, senior vice president and medical director of the March of Dimes. “Women who already have had a baby born prematurely should check with their health care provider to see if this treatment is appropriate for them. This treatment is not for everyone.”

The FDA approved hydroxyprogesterone caproate injection, commonly known as 17P, which is a synthetic form of a hormone produced during pregnancy. It will be marketed under the brand name Makena™ and given in weekly injections to pregnant women between 16 and 20 weeks gestation and continuing until 37 weeks gestation. The drug is approved for use by women pregnant with one baby and who already have a baby who was born before 37 weeks of pregnancy either because labor began on its own, without drugs or other methods, or because the membranes surrounding the baby ruptured too early.
Prior to today’s approval of Makena™, health care providers ordered prescriptions of 17P from compounding pharmacies; however, many eligible patients faced logistical and financial barriers to access. FDA approval means the drug now will be widely available only in specialty pharmacies and that there will be improved access of the drug through healthcare coverage.

A published study by the March of Dimes, the National Institutes for Health, and the Centers for Disease Control and Prevention, using data from 2002, estimated that if all women eligible for the progesterone injections received them, nearly 10,000 spontaneous premature births might be prevented each year.
This makes the treatment much more accessible and we hope that private production doesn't mean it will be expensive.  Something that can prevent any preterm births will save millions of health care dollars.

An update:  It appears that the manufacturers intend to charge an exorbitant amount for Makena which, when compounded, was costing about $10 a dose so even those without insurance or medicaid could afford it.  Now, even though the drug safety has already been determined and the company does not have to do all those expensive studies, they still plan to take advantage of the people and contribute to exploding health care costs.  Stay tuned...

Update 3/31/11:  Check out the FDA taking a stand against the high pricing and letting the compounding pharmacies know they can continue to produce this drug as previously (read low-cost).  Yay, FDA!  Read here. Best Blogger Tips

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