The compounding pharmacy problems that have been so hard on patients and landed the FDA in the doghouse have been a savior for at least one company, KV Pharmaceutical, and its premature birth drug Makena.
KV had to file for bankruptcy reorganization last year when its single product was shunned by payers who could turn to compounders for much cheaper versions. KV cut the price significantly, but also has been able to ride the compounding scandal by touting its product as FDA-approved, and so safer, The Wall Street Journal reports. While sales are not what KV first hoped for when it priced Makena at $1,500 a dose, compared to $10 for a compounded version, they hit $29 million in the first quarter. That is nearly 125% more than the third quarter of 2012 before a compounded pain drug was tied to fungal meningitis outbreak that has sickened 741 people, 55 fatally. Doctors tell WSJ that sales reps for KV have been using the "M" word, suggesting they could be sued for malpractice if they use a compounded versions and a patient gets sick.
The FDA last year approved Makena, a hormone given to pregnant women with a history of giving birth prematurely. The agency, however, refused to ban compounded versions of the drug, which go for $10 to $20 a dose compared to the $595 price KV finally landed on. The St. Louis, MO-area company sued the FDA and said if the agency didn't ban compounded versions of the drug, it would have to file for bankruptcy. The FDA didn't and KV did. It has since agreed to sell the drug for less than $300 a dose to some state Medicaid programs as it seeks to find a market for its only product.
The big turning point, The Wall Street Journal reported, occurred when the FDA began a crash inspection of large compounders and had many of them recall their sterile injectable products because of questions over the sterile conditions of their operations. The agency took that step after hundreds of patients around the country got sick from fungal meningitis after taking a drug made by New England Compounding Center. Although none of the meningitis deaths have been linked to the compounded version of the premature birth drug, it was among the medications that the compounding pharmacy produced and recalled after patients began turning up sick.
- read the Wall Street Journal story (sub. req.)
KV, Hologic reach $60M deal on Makena
FDA finds bugs, birds, failed 'event' follow-up during Ameridose inspection
Loss of Makena suit against FDA compounds KV's problems
KV bargaining with states on price of Makena
Escalating problems culminate in K-V Pharmaceutical bankruptcy
FDA keeps door open to cheap versions of K-V's Makena