Cost of Injection Jumps from $15 to $1,500

The following is from an AP story. See also Merrill Goozner’s comments here.

A drug for high-risk pregnant women has cost about $10 to $20 per injection. Next week, the price shoots up to $1,500 a dose, meaning the total cost during a pregnancy could be as much as $30,000.

That’s because the drug, a form of progesterone given as a weekly shot, has been made cheaply for years, mixed in special pharmacies that custom-compound treatments that are not federally approved ….. But recently, KV Pharmaceutical of suburban St.Louis won government approval to exclusively sell the drug, known as Makena (Mah-KEE’-Nah). ….. 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.To get FDA approval, the company is spending hundreds of millions of dollars in additional research, including an international study involving 1,700 women, Divis said. The FDA last month signed off and gave Makena orphan drug status. That designation ensures Ther-Rx will be the sole source of the drug for seven years.

Last month, KV sent cease-and-desist letters to compounding pharmacies, telling them they could face FDA enforcement actions if they kept making the drug.

Comments (6)

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  1. Devon Herrick says:

    This case is similar to the gout drug, when the FDA granted exclusive status to a drug company that merely tested a drug that had been used for decades.

  2. Ken says:

    Looks like we can blame this on the FDA. Everyone wuld have been just fine, but for its approval rules.

  3. Stephen C. says:

    I think I agree with Ken. Everything was just hunky dory until the FDA gave a pharmaceutical firm a monopoly.

  4. Vicki says:

    This is outrageous.

  5. It goes to show how hard it is to resist bureaucracy. According the the AP story, the medical director in charge of women’s health for Aetna was not aware of problems with the pharmacy-compounded drug, but the FDA acted anyway.

    According to a 2003 story the number of compounding pharmacists in the US increased from only four in 1980 to 3,500 in 2003. They’ve got their own trade association ( But they still couldnt’ stop this FDA action that dramatically increased the price of medicine for a vulnerable, helpless, population.

  6. Virginia says:

    A darn shame. Who is it that always says Tylenol would never get FDA approval if it came up for review? Imagine paying $30 a pill for a pain killer!