Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Monday, June 3, 2013
KV rebounds as docs get uneasy about compounded drugs Sales reps suggest they could get sued if patients gets sick from compounded version of Makena June 3, 2013 | By Eric Palmer
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.