How much are you willing to pay for a drug? We often takefor and we hope granted that all drugs will go generics and at that time drugs will be cheaper. Lovenox has gone generics but its generic equivalence is not much cheaper than the branded one.
Most of the time, we also think pharmaceutical companies have charged too much for a single pill but then this single pill can lower certain vital sign that could help fending off other complications. So will you be willing to pay for it in order to decrease the chance of having a certain disease?
Once in a while, I do think about how much should a drug cost? They said it only costs less than a dollar or sometimes penny to manufacture a single pill. I guess it would depend on what type of meds you talk about. I have seen 100 acetaminophen tablets sold for one dollar a bottle. Don't ask me where I see it but it does exist. So how much does it really cost to manufacture a product? The manufacturing process might not be expensive because you just need to buy a machine that can automate many things. However, you have to keep up with a long list of regulation that each manufacturing facility needs to comply. Some companies do maintain good practice and comply with the federal and state law. Some companies do not do so and end up recalling their products when the situations get out of hands. So is it hard to be compliant with the regulatory agency? If you think it's hard to remember to take a single tablet a day or two tablets a day, complying with the regulatory agency can also be a harder business.
The reason I'm writing this post is because of Makena. Makena has just been approved by the FDA to be used in the reduction of the risk of certain preterm births in women who have had at least one prior preterm birth. Since then, KV Pharmaceuticals has been under attack for raising the price of the drug. It costs more than $1000 for a single shot. Will a patient be willing to take it? does the benefit outweigh the cost of the drug? I think anyone who has not experienced or had not delivered a premature baby should answer this question. Of course, one cannot understand the pain associated with the delivery process. How can one understand the fear of something can possibly happen to one's baby if the baby is prematurely born? How many of us who have written about premature delivered baby actually has one? So shouldn't the decision be on the hand of the people who are at risk the most? But should the drug company take advantage of this special population to charge them an enormous amount of money? But when the company thought it can charge patients a huge amount of money for the newly approved drug, something else have already been prescribed and used.
Makena is the brand name for hydroxyprogesterone caproate. It is a sterile product however its cousin synthetic progestin has been available for a long period of time and compounded by pharmacists at pharmacy. You might wonder so what is the relationship? Compounding pharmacy can be considered as manufacturing which would end up requiring the pharmacy to comply with the Good Manufacturing Practice dictated by the FDA. However, a compounding pharmacy is not considered as a manufacturer if it only compounds products with valid prescription and does not appear to be a wholesaler.
Recently, KV pharmaceuticals sent out a letter to pharmacists stating that the FDA will not allow the compounding practice of medications that are similar to Makena. The FDA has stated that the letter is not a true statement. The FDA does not intend to "take enforcement action against pharmacies" compounding hydroxyprogestoerone caproate if the pharmacy is presented with a valid prescription for an individually patients under the conditions that the products are safe, of standard quality and compounded with appropriate standards for compounding sterile products.
KV Pharmaceutical shares fell dramatically after the FDA announced its decision on the subject because now the company even though has 7 years market exclusivity because Makena is an Orphan Drug, compounding pharmacies can legally compound versions of Makena for patients who present to the pharmacy with valid prescriptions.
What do we learn from this? having a drug approved is just the beginning. Upsetting the public by setting the price too high could potentially cause a backslash because when a drug is too expensive, one will start to wonder whether it is worth it to take it. In this case, the drug can be compounded at a compounding pharmacy. So what is the chance that the costly drug marketed by KV Pharmaceutical will sale? I just think KV Pharmaceuticals should consult with their finances before coming up with the price that is this high for a product that can be acquired at a much lower price. Do you think a lawsuit will be initiated upon the release of the FDA statement? KV Pharmaceuticals will probably try to do something about this or it will lose its market share.
