FDA Fast Track Approval of Pre Natal Drug Turns KV Pharmaceutical into a Greedy Money Machine With Pricing for Makena

As the article states this injection, when compounded by local pharmacies used to cost around $10 and now that cost is $1500 per injection, what a rip. KV has the exclusive rights to market under the name Makena. Obgyns are outraged. Over the full course of pregnancy the cost for the injections would cost maybe $400 maximum and now the same treatment is $30k. Greed! Their former CEO by the way was just sentenced today to 30 days and a $1.9 million dollar fine for misbranding drugs.

Just at the time when more generic and cheaper drugs are needed, with having the exclusive, this huge mark up takes place, kind of evil if you ask me. Both estrogen and progesterone have been tried forever to prevent miscarriages and they don’t work. Makena is an artificial form of progesterone. KV has stated they will conduct 2 post marketing studies on the drug to see if it does in fact reduce the rate of pre-term births. KV with their pricing is definitely not popular for women expecting as well as obgyns. This begins today and along with the big price you also get a free web page with patient assistance information and the new program. BD

For decades, special pharmacies have been making and selling a synthetic form of progesterone, a female hormone, to help prevent premature childbirths. However, because of the informal nature of the drug, different pharmacies sometimes made it in differing strengths.

So the Food and Drug Administration, attempting to standardize production and use of the compound, classified the compound as an orphan drug and granted KV Pharmaceutical the exclusive right to produce and market it for the next seven years. The compound went on sale today under the brand name Makena.

However, the FDA is empowered to monitor only the safety and effectiveness of drugs; it does not have the power to control how much KV Pharmaceutical charges for the compound. And KV Pharmaceutical has now announced that a drug compound that has typically cost $10 to $20 an injection will now cost $1,500 an injection. Over the course of a pregnancy, treatment that once cost as much as $400 will now cost $30,000.

Makena: How to turn a $10 drug into a $1,500 drug | Jay Bookman