How the FDA Turned a $10 Treatment into a $30,000-Per-Pregnancy Pharmaceutical Money-Maker

Alliance for Natural Health

March 22, 2011

When a new FDA drug-and-money scandal has doctors, US senators, and even the March of Dimes in an uproar, you know it’s bad. A new Action Alert!

A drug which the FDA approved more than half a century ago—which doctors have been prescribing for their patients with high-risk pregnancies through compounding pharmacies with great success—was designated by the FDA an “orphan drug.” Now KV Pharmaceutical has been given the exclusive right of production and sale (not to mention drug trial tax breaks!). They immediately raised the price from $10 per dose to $1,500—simply because they could.

The drug is a synthetic form of progesterone given as a weekly injection. It has been made cheaply for years and produced in compounding pharmacies. The price hike means that the total cost during a pregnancy could be as much as $30,000.

Doctors say the $30,000 price tag will almost certainly deter low-income women from getting the drug, leading to more premature births. Dr. Roger Snow, deputy medical director for Massachusetts’ Medicaid program, was quoted as saying, “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!” And Dr. Arnold Cohen, an obstetrician at Albert Einstein Medical Center in Philadelphia, observed, “I’ve never seen anything as outrageous as this.”

Besides the grave jeopardy placed on the mothers and their infants, this will create a huge financial burden for the health insurance companies, private citizens, and government programs that have to pay for it. In the long run, because of birth complications, the babies will need to be hospitalized for perhaps months—and, for low-income mothers, all at the expense of taxpayers. On top of that, lung issues at birth can have lifelong repercussions on the individual’s health with an increased propensity toward asthma, bronchitis, and pneumonia, among other early birth issues.

The March of Dimes—a nonprofit organization dedicated to preventing birth defects—received funding from KV Pharmaceutical and supported the company’s New Drug Application. Now the organization has started backtracking in the face of all the public outrage. They just sent a letter to KV “expressing our serious concern about the price of Makena.”

Sen. Sherrod Brown (D-OH) has sent a letter to KV Pharmaceutical asking the company to “immediately reconsider” its pricing. “I am deeply concerned that your company appears to be taking advantage of FDA approval at the expense of women, children and federal and state budgets,” Brown wrote. “By ratcheting up prices, fewer women will be able to afford the drug, increasing rates of preterm birth nationwide. This isn’t in the interest of children, new mothers, or taxpayers.” Sen. Brown, along with Sen. Klobuchar, followed this with a letter to the FTC commission to investigate potential anticompetitive conduct by KV Pharmaceutical from the increase in price.

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