* Lawsuit focused on cheaper versions of preterm birth drug
* Judge says FDA's actions not subject to judicial review
* K-V filed for bankruptcy in August
NEW YORK, Sept 6 A K-V Pharmaceutical Co
lawsuit against the U.S. government seeking to ban
sales by pharmacies of cheaper, unapproved versions of its
premature birth drug Makena was dismissed by a federal judge
U.S. District Judge Amy Berman Jackson in Washington, D.C.
made the decision a month after the company filed for bankruptcy
protection, blaming inaction by the Food and Drug
K-V had filed the lawsuit in July in an unsuccessful
last-gasp attempt to stay afloat, saying it would not have
enough revenue from Makena sales to pay its creditors if the FDA
did not take action against the unapproved versions.
The injectable hormonal drug reduces the risk of pre-term
birth in women who have delivered early in the past.
Pharmacies had already been compounding such a drug for
years at far lower prices than Makena, using an active
ingredient, hydroxyprogesterone, available on the market without
formal FDA approval.
K-V gained approval to sell Makena last year.
"The central issue for K-V Pharmaceutical ... has always
been to ensure that pregnant women have access to Makena, the
only drug approved by the FDA for their condition," company
spokesman Tony Herrling said.
K-V had claimed in its lawsuit that the FDA had decided not
to crack down on the pharmacies out of concern for insurance
companies' costs, rather than patients' needs.
But Jackson said in her ruling that the FDA's move was
within its discretion and by law is not subject to judicial
"This case is fundamentally an effort to get the court to
direct and oversee the FDA's enforcement activities, and that it
cannot do," she wrote.
FDA representatives could not immediately be reached for
comment Thursday evening.
The case is K-V Pharmaceutical Company v. FDA, U.S. District
Court, District of Columbia, No. 12-01105.