FDA, KV Pharma Bend A Bit To Public Pressure; Lower Makena Costs, Allow Competing Drugs To Remain... For Now

from the public-pressure-works dept

We've been discussing how the FDA has been systematically banning drugs that have been on the market for years, and retroactively granting monopolies to particular pharmaceutical firms. The case that's drawn the most attention is that of Makena, a drug to prevent early childbirth which is provided on the market by a bunch of different firms, and was competitively priced around $10/dose. Yet, after the FDA stepped in and gave a monopoly to KV Pharmaceutical under the economically-clueless belief that this would help make the drug "more available," there was a massive public backlash when people discovered KV would increase the price of the drug from $10 to $1,500.

In response, it appears the FDA is backing down ever so slightly. Drew points us to the news that it has put out a statement that it will not stop other pharmacies from making and offering the drug. KV had been threatening others, but the FDA stepped in and said that, even though it's granted this monopoly to KV, it wouldn't enforce it against these other manufacturers. The FDA put up a statement explaining this:

In order to support access to this important drug, at this time and under this unique situation, FDA does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality, or are not being compounded in accordance with appropriate standards for compounding sterile products.

Of course, it also says it may change its mind on this at any time (i.e., after the attention and backlash die down) and appears to have no interest in revisiting its other new monopolies.

Not surprisingly, with this news in place, KV Pharmaceutical has also announced that it is dropping the $1,500 price down to $690. Of course, that's still a lot more than $10 per dose, and this seems in response to the fact that (a) the public is blasting it at every turn and (b) the FDA won't really enforce the monopoly... for now.

How about we try to fix the underlying problem of monopolies, rather than just focusing on this one case?

Filed Under: drugs, fda, makena, monopolies, pharma
Companies: kv pharmaceutical

Senators Want Investigation On Massive Increase In Drug Prices... But Will They Really Seek A Solution?

from the monopolies-are-bad dept

We recently covered the news that the FDA had retroactively granted a monopoly to KV Pharmaceutical on the widely used drug Makena (which is used to prevent premature births). The drug had been sold at $10 per dose, but the second KV got the monopoly, it pushed the price up to $1,500 per dose -- or around $30,000 vs. $200 for a full treatment. The news of this massive price hike certainly got a lot of attention, and now two Senators are asking the FTC to investigate KV Pharmaceutical to see if this is legit. It's nice to see the Senators, Sherrod Brown and Amy Klobuchar, stepping up to express their concern about this, but if they really wanted to make a difference, they shouldn't just be investigating KV. After all, KV is playing by the rules that the US government set up. What they should really be exploring is why we give monopolies on important life saving drugs that create problems like this in the first place?

Filed Under: amy klobuchar, drugs, makena, monopolies, patents, sherrod brown
Companies: kv pharmaceutical

Retroactive Drug Monopoly Raises Rates From $10... To $1,500

from the the-high-price-of-monopolies dept

A bunch of you have been sending in the somewhat horrifying story of how KV Pharmaceutical has been retroactively granted a monopoly on the drug Makena, which is use to prevent premature births. The product has been on the market for years, and normally costs about $10 per dose... but thanks to the new monopoly, the price is immediately jumping up to an astounding $1,500 per dose -- and this is something that many pregnant women need around 20 doses of during their pregnancy. That increases the overall price from about $200 to $30,000. For something that's been on the market for years. I'm reminded of Thomas Macaulay's famous statement:

"the effect of monopoly generally is to make articles scarce, to make them dear, and to make them bad."

Tragically, many obstetricians and the March of Dimes had vociferously supported this move, without understanding the basic economics of monopoly pricing. They thought that granting a monopoly to one company would mean that it would make the drug "more available." Joke's on them, and now they're upset:

"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.

"I'm breathless," said Dr. Joanne Armstrong, the head of women's health for Aetna, the Hartford-based national health insurer.

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.

It's really amazing that people don't understand the basics of monopoly pricing and how drastically it has distorted the market for drugs. Hopefully this story of Makena will get some people to wake up as to why this is a massive problem.

Filed Under: drugs, economics, makena, monopolies, prices
Companies: kv pharmaceutical