Tag Archive | "quality control"

Low-cost Preterm Birth Drug Won’t Be Stopped by FDA


All pregnant mothers will still have access to cheap drugs that will prevent premature birth said federal health officials, Wednesday.

Since the $1,500 version of this drug was approved, it was unclear whether or not pregnant women will still be allowed to buy from specialty pharmacies that sell the drug for an average of $15.

Many people, doctors and pregnant women alike, reacted negatively on the drastic price increase on the drug. The Food and Drug Administration (FDA) finally said, Wednesday, that specialty pharmacies can continue to make cheaper versions of the drug that decreases the risk for preterm labor as they did for the past few years.

Many doctors welcomed the concept of the new drug because they said it can assure quality control of the drug. They were, however, shocked by the price; they simply did not see it coming. FDA said that they do not have the authority to control drug prices.

KV Pharmaceutical Co., the government-approved exclusive distribution of the drug insisted that the price of the drug is justified considering the costs of caring for a prematurely born child. They further said that they will make sure everyone who needs the drug will gain access to it. The pharmaceutical company will make a statement on drug pricing within the week.

One month ago, KV Pharmaceutical sent letters to other pharmacies creating and selling the drug for a lower price, warning them to shut down operations or else they will face the FDA. FDA initially backed this letter but did otherwise, Wednesday.

The department, however, realized how upset the public became after hearing about the 1,500 dollar drug. FDA said, Wednesday, that under this unique situation they will not take actions against pharmacies in order to ensure accessibility of the said drug.

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Preterm Labor Prevention Costs Skyrockets to $1,500 from $10


Preterm Labor Prevention Cost SkyrocketsThe cost of preventing preterm labor is expected to increase in huge numbers anytime soon. The drug injected to women with high-risk pregnancies costs between $10 and $20 per dose. In just a few days, the price per dose will go up to as much as $1,500.

This drug is a kind of progesterone given weekly to prevent preterm labor and all its corresponding complications for both the mother and the child. For years, this drug was sold cheaply because they are mixed in pharmacies that are not approved by the Bureau of Food and Drugs. Just recently, however, KV Pharmaceutical was approved by the government to exclusively manufacture and sell the drug.

Most obstetricians backed the decision as this can ensure quality control and easy-accessibility. None of the doctors, however, foresaw the dramatic increase in size considering that research and development were not shouldered solely by KV Pharmaceutical.

Most doctors fear that the drug’s price increase will rob many women of the opportunity to prevent premature births; especially those who are not covered by medical insurances and low-income mothers. Moreover, Massachusetts’ Medicaid deputy medical director Dr. Roger Snow said that this increase can cause a massive financial blow on health insurance companies and may push them to increase health insurance package costs.

KV Pharmaceutical stands firm in their decision as they believe that the cost of the drug is nothing compared to the cost of care for children born prematurely. On Tuesday, Ther-Rx Corporation (a KV subsidiary) announced that they will launch a patient assistance program that will offer the drug at a smaller cost for low-income women.

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