Thread: Does FDA Approval Mean Monopoly?

Does FDA Approval Mean Monopoly?

Ok so here's the deal. A progesterone shot that aids in the prevention of premature births was priced at $10 to $20 per injection, but was made cheaply in special pharmacies that custom-compound treatments that were not federally approved, but effective. Now that KV Pharmaceutical has gained FDA approval for Makena, the price will go up to $1,500 a shot and as much as $30,000 throughout a pregnancy.

Just approved by the FDA last month, KV's Makena is a commercial form of the low-cost progesterone treatments used by women for years. Considering the FDA has been on something of a crusade to sweep aside unapproved drugs. The medical community had supported KV's quest to win the FDA nod for Makena, but were not expecting a price increase of over $1,000 USD.

Makena, commonly referred to as "17P," is the first and only FDA-approved treatment indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth, which is a subset of the overall population of women at risk for preterm birth.

According to the March of Dimes, preterm birth, or the birth of a baby at less than 37 completed weeks of pregnancy, affects one in eight babies born in the United States. Additionally, the rate of preterm birth has increased more than 35% in the last 25 years, and late preterm births, or babies born at 34 to 36 weeks of pregnancy, account for nearly three quarters of all preterm births in the United States.

In 2005, preterm birth was estimated to cost the nation more than $26 billion. According to a study published in Obstetrics and Gynecology, although the causes of spontaneous preterm birth are often unknown, a leading risk factor for preterm birth is a history of prior preterm birth.

Alan R. Fleischman, M.D., Medical Director, March of Dimes states:

"Preterm birth is a national healthcare crisis. The approval of this new treatment is a breakthrough in our fight against preterm birth. Although the United States has made great progress in caring for premature babies, there is no greater advance than allowing a baby to mature in a mother's womb."

The latest research suggests that many cases are triggered by the body's natural response to certain infections, including those involving amniotic fluid and fetal membranes. However, in about half of all cases of premature birth, providers cannot determine why a woman delivered prematurely.

About 25% of premature births are caused by early induction of labor or c-section due to pregnancy complications or health problems in the mother or the fetus. In many of these cases, early delivery is probably the safest approach for mother and baby.

However, the March of Dimes is concerned that some early deliveries may occur without good medical justification or may be done at the request of the mother. In some cases, this can lead to late-preterm birth, with potential risks to the baby. Women should wait until at least 39 weeks to schedule an induced labor or a c-section, unless there are medical problems that make it necessary to deliver earlier.

Greg Divis, Chief Executive Officer, K-V Pharmaceutical Company and President, Ther-Rx Corporation said:

"The communities of healthcare providers and advocacy organizations who are on the front lines of this issue now have access to the benefits of an FDA-approved product. The approval of Makena is not only a milestone for the Company; more importantly, it represents a significant step forward for the thousands of women whose families have been impacted by preterm birth."

Sources: KV Pharmacutical and The March of Dimes

Written by Sy Kraft, B.A.

KV, Makena And Preemies: Does FDA Approval Mean Monopoly?

Originally Posted by Prince

Does FDA Approval Mean Monopoly?

A progesterone shot that aids in the prevention of premature births was priced at $10 to $20 per injection, but was made cheaply in special pharmacies that custom-compound treatments that were not federally approved, but effective.

How were they using a medication that hadn't been approved???