Pharma Company Sues FDA

The maker of a pregnancy medication takes action against the federal agency for not stopping pharmacies from making and selling cheaper versions of the drug.

By | July 10, 2012

image: Pharma Company Sues FDA Ampule and syringe on abstract coloured background. Leonardini | stock.xchng


St. Louis-based K-V Pharmaceuticals, which makes a hormone injection for reducing the risk of pre-term births, is suing the US Food and Drug Administration (FDA) for not stopping pharmacies from offering a cheaper, self-made preparation of the medicine. The FDA-approved Makena hit the market early last year, originally retailing at $1,500 per injection. However, for years, pharmacies had been making compounded versions of the product using the drug’s active ingredient, hydroxyprogesterone, and selling them for $10 to $20 a pop, Reuters reported.

K-V Pharmaceuticals has been trying to deter pharmacies from doing this by sending warning letters and threatening with lawsuits, prompting accusations of price-gouging by insurance companies, lawmakers, and the public. In light of the company’s plummeting share prices and the looming threat of bankruptcy, K-V has filed a lawsuit against the FDA for not stopping the distribution of unapproved versions of the medicine, and for basing its decisions on costs instead of science.

In June, the FDA said it would not take action against pharmacies after a limited investigation found that, while the compounded versions contained more impurities than K-V’s Makena, they posed no health risk, FiercePharma reported. The FDA also stated that its actions are within line of the agency’s policy regarding compounding practices, which require that it be done at a small scale and with a doctor’s prescription.


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Avatar of: Barbara Struthers

Barbara Struthers

Posts: 1457

July 10, 2012

KV went into this market with the idea that they could bilk consumers and generate great profits by getting an old tried-and-true therapy approved as a new drug.  Of course consumers balked.  This sort of approach to getting a "new drug" on the market should be discouraged at all levels; it does nothing to improve therapy, and simply increases medical costs.

July 17, 2012

 K-V Pharmaceuticals has poor decision makers in charge.  They failed to factor in free-market competition.  I have no sympathy for a company that has so little understanding of the very market with which that company is involved.  K-V has no one to blame but themselves.  I hope their lawsuit gets tossed. 


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