Entries in Preemie Drug (1)


FDA May Allow De Facto Generic of Pricey Preemie Drug Makena

Paul Tearle/Thinkstock(WASHINGTON) -- The Food and Drug Administration has no intention of enforcing a regulation that one drug company sought to exploit to drive out competitors, an FDA official told ABC News.

The regulation invoked earlier this month by KV Pharmaceuticals would have allowed the company to corner the market for a drug used to prevent preterm births and sell it for 150 times what had been the going price.

KV Pharmaceuticals gained exclusive rights in February to produce a progesterone shot used to prevent preemie birth that it branded Makena. The shot had been offered by compounding pharmacies for between $10 and $20 per dose, but KV planned to sell it for $1,500 per dose.

The company then sent cease-and-desist letters to compounding pharmacies, saying the FDA would take action against them if they continued to synthesize the drug.

Though the FDA has not made an official statement, an official there, speaking on the condition of anonymity, told ABC News that this "is not correct" -- the FDA would not take action against these companies.

Because the FDA has no control over how companies it grants drug approval set prices, some health care experts said these comments, couched in anonymity, seem like an attempt to lessen the unintended consequences of the decision to grant KV Pharmaceuticals seven years of exclusive rights to the drug under the Orphan Drug Act.

Doctors, however, say they will need more than an anonymous comment to feel comfortable prescribing the unregulated, compounding pharmacy-made version of the drug.

KV Pharmaceutical have responded to the price controversy by announcing a Comprehensive Patient Assistance Program for Makena in which households, both insured and uninsured, making less than $100,000 a year will be subsidized.

In a statement to ABC News, KV Pharmaceuticals and partner company Ther-Rx, wrote: "We are committed to taking the appropriate steps to help ensure that all clinically-eligible patients have access to Makena."

Copyright 2011 ABC News Radio

ABC News Radio