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

ANH ^ | March 20, 2011

[La Lydia]

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 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.”...

As soon as FDA gave the drug (now trademarked as Makena) orphan drug status, its manufacturer, KV Pharmaceutical, sent a cease-and-desist letter to compounding pharmacists, stating that “FDA…views compounded drugs to be ‘new drugs’ within the meaning of 21 U.S.C 312(p) and as such they may not be introduced into interstate commerce without FDA approval.”

The Orphan Drug Act is meant to encourage pharmaceutical companies to develop drugs for diseases that have a small market, and it has resulted in medical breakthroughs that may not have otherwise been achieved due to the economics of drug research and development. But this is a drug which was already developed, already approved, already in use, and has been costing $10 per treatment for many years. To raise the price to $1,500 per injection just because they can is unconscionable....

[uncommonsense]

Same issue with GHB. It was a cheap supplement readily available in healthfood stores that acted as a fantastic sleep aid (and helps with fibromyalgia by promoting stages 3 or 4 sleep that are the restorative levels). But it got a bad rap as “the date rape drug” and is now called Xyrem, costs $1,800/mth, and is distributed through a single pharmacy. Instead, the FDA would rather people take the less effective, more toxic Ambien and perform many of their normal daily activities, like driving a car, while actually being asleep.

[devnull]

This is priceless, from the headline ... “Former CEO of KV Pharmaceutical Pleads Guilty to Misbranding Drugs and Agrees to Pay U.S. $1.9 Million in Fines and Forfeiture”

[bjc]

Thanks for the link. Interesting story. I would have thought that the quality control process for wrong sized pills was pretty simple. Why would the FDA let these guys have any advantage in the marketplace - let alone a monopoly on an existing compound.

[La Lydia]

I am allergic to codeine, so on the rare occasions I have needed a painkiller, such as when I had my wisdom teeth removed, Darvocet was my go-do drug. It worked, it made the pain go away, and it didn’t leave me muddled and foggy. Anything that works and is cost-effective is apparently banned.

[Dr. Bogus Pachysandra]

“When I was young, in the 50’s, my doctor would prescribe it.”

Back in those days, and much later, an adult could walk into a drug store and just sign for it. No prescription required. And that’s the way it should still be! Nowdays, if I have a chest cold, I have to pay $80 for a Doc appt., and he’ll not be able to really do anything for the chest cold, but write a script for cough medicine with hydrocodone in it. And I can’t take that stuff. Manufacturers seem to always put some kinda “non-drowsy” stuff in there, and I’m hyper-sensitive to that cr@p! If the old medicines make me drowsy? Fine! I’m sick, and I’ll take a nap!

[don-o]

ping