The FDA has announced that it will allow compounding of hydroxyprogesterone caproate, in the wake of Makena manufacturer K-V Pharmaceutical’s plan to bring the previously inexpensive generic product to market at a price 100 times its cost.
FDA understands that the manufacturer of Makena, KV Pharmaceuticals, has sent letters to pharmacists indicating that FDA will no longer exercise enforcement discretion with regard to compounded versions of Makena. This is not correct.
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. As always, FDA may at any time revisit a decision to exercise enforcement discretion.
There will be those who will argue that this will discourage pharmaceutical companies from producing so-called orphan drugs, and somehow try to make this case into something bigger than what it is, which is simply the story of how the new management of one drug manufacturer tried to turn a bad company around by turning a small profit maker into a blockbuster drug.
I happen to agree (for once) with my Pharma-friend Schrugglin’s comment on my prior Makena post that the FDA holds a significant portion of the blame here for not steering this product towards a more reputable manufacturer. I encourage you to read his thoughtful comments if you want Pharma’s side on this issue.
Hopefully the FDA and KV will come to a compromise that will allow Makena to turn a profit for KV without them resorting to price gouging. Stockholders may need to adjust their expectations a bit more in line with reality.
The sad thing is that we have created an industry whose only definition of success is blockbuster. While that may work for the movie industry, it’s not appropriate for healthcare. We need to readjust the business model.
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More on Makena –
- St Louis Dispatch – March of Dines, Am Acad of Peds and ACOG met with KV to persuade KV to lower price
- Via Pharmalot – KV Stock plummets, and there are parallels to the colchicine story
- Corante In the Pipeline – Interesting discussion in the comments section on the issue
- Health Reforms Watch – After Makena – Is there a better business model?
- Gekkowire outlines KV’s finances and reveals how much it had counted on Makena profits
She loves me…she really loves me!
Glad to see that the FDA has some perspective here. Don’t fret about companies ignoring Orphan Drugs going forward. This situation is a bit unique in that product was already available in the market via compaounding pharmacies. Most Orphan Drug situations are that there is NO supplier of product any more, and that patients are not getting therapy. In those circumstances, there is still an opportunity for both the company and the patient to get what they need, but that are a bit more balanced.
The FDA clearly sees that they were blinded by procedure and policy, and course corrected. However, keep all hands and feet in the car at all times, because this roller coaster ride is not over. Expect KV to respond and to try and secure the market through the patents that they hold for the formulation.
The blockbuster model is not viable and the industry is more than aware of it. Clear enough. Especially for traditional small molecules. Still viable for the biologic products though. However, more important than ever is staying profitable. I believe that the FDA needs to step in and work with industry to drive costs for development down so that more smaller drugs survive and the need for high margin products lessens. We are still out of whack overall even if MAKENA has some more balance now.
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