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K-V Challenge To FDA's Enforcement Order On Thin Ice: Judge

By Erica Teichart

Law360, Washington (August 07, 2012, 10:30 PM ET) -- A Washington federal judge indicated Tuesday that forcing the U.S. Food and Drug Administration to block pharmacies from producing cheaper compounded versions of K-V Pharmaceutical Co.'s preterm birth prevention drug Makena is an unlikely action, as the agency's enforcement discretion cannot be judicially reviewed.

While K-V claims that the FDA isn't following its traditional enforcement procedures and that it encouraged pharmacies to produce cheaper, compounded versions of Makena's active ingredient — 17-hydroxyprogesterone caproate, or 17-HPC — via a March 2011 press release, U.S. District Judge Amy Berman Jackson said the agency's statements may not be eligible for review.

“You want me to be the super law enforcement officer over the FDA,” Judge Jackson said. “I'm worried about the notion that I'm now overseeing this thoroughly discretionary act.”

However, K-V's attorney Richard M. Cooper of Williams & Connolly LLP argued that Congress never intended to allow federal agencies take advantage of their executive privilege and bankrupt private companies, and urged the judge to issue a broad court order that would make that FDA enforce Makena's market exclusivity under its own terms.

K-V filed for Chapter 11 protection on Saturday in New York, citing its inability to realize full value on Makena and a $45 million milestone payment due on a related rights agreement with Hologic Inc. as key factors.

The FDA initially said it would take enforcement action on pharmacies creating compounded versions of the premature birth prevention treatment in March 2011, but later backtracked, saying it wouldn't take additional steps against the unapproved versions.

“We do not seek this court to tell the FDA how to do their job,” Cooper said. “We ask them to tell them what their job is.”

But Judge Jackson and FDA both noted there would be no way to measure the success of a vague order like the drugmaker proposed. The FDA's counsel Gerald Cooper Kell added that even if the agency tried to shut down the compounding pharmacies, there is no guarantee K-V could regain its market share.

“The plaintiff has to allege something in more than a speculative way,” Kell said. “That seems to me to be the height of speculation.”

Judge Jackson also said that the FDA may not have issued the release if K-V hadn't sent letters to doctors and pharmacies threatening malpractice suits and regulatory action if they didn't stop prescribing and manufacturing the compounded 17-HPC.

K-V defended the letters as a legitimate sales technique** to entice doctors to prescribe their $1,500 per injection remedy over the $10 to $20 alternatives.

According to K-V, restrictions on reimbursement imposed by state Medicaid agencies and restrictions on manufacturing and marketing of K-V products implemented by a March 2009 FDA consent decree have significantly affected its revenues and ability to meet short- and long-term obligations.

K-V is represented by Richard M. Cooper, Holly M. Conley and Michael V. Pinkel of Williams & Connolly LLP.

The case is K-V Pharmaceutical Co. et al. v. U.S. Food and Drug Administration et al., case number 1:12-cv-01105, in the U.S. District Court for the District of Columbia.

--Additional reporting by Lisa Uhlman. Editing by Andrew Park.

**Coming Soon! IACP will host a webinar on what to do when you receive a “cease-and-desist” letter from a manufacturer. Click here for more information about IACP's live and on-demand webinars.

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