A synthetic female hormone that has been used for decades to help prevent premature childbirths was recently classified by the FDA as an orphan drug. This classification lead to the FDA granting KV Pharmaceutical exclusive rights to market and produce the drug they call Makena for the next seven years.
The FDA was concerned that different pharmacies mixing the drug would sometimes mix it with slightly different strengths, and felt that regulation was the best option. The problem for patients is that while the FDA can regulate who can create the drug, they cannot set any rules as to the price charged for it.
The drug is given as a injection periodically during pregnancy recently cost the patient around $400, but will now cost nearly $30,000.
The Associated Press reports:
That’s a huge increase for something that can’t be costing them that much to make. For crying out loud, this is about making money,” said Dr. Roger Snow, deputy medical director for Massachusetts’ Medicaid program.
“I’ve never seen anything as outrageous as this,” said Dr. Arnold Cohen, an obstetrician at Albert Einstein Medical Center in Philadelphia.
Doctors say the price hike may deter low-income women from getting the drug, leading to more premature births. And it will certainly be a huge financial burden for health insurance companies and government programs that have been paying for it.
The cost is justified to avoid the mental and physical disabilities that can come with very premature births, said KV Pharmaceutical chief executive Gregory J. Divis Jr. The cost of care for a preemie is estimated at $51,000 in the first year alone.
With all of the issues the United States faces with healthcare spending and costs, this is a prime example of the ever growing problem. This type of price gouging would not be allowed in most other countries.
If you want to help make a difference you can contact KV Pharmaceutical and share your opinion:
KV Pharmaceutical Company
One Corporate Woods Drive
Bridgeton, MO 63044
Phone: 314-645-6600
Fax: 314-646-3751
E-mail: investorrelations@kvpharmaceutical.com
