FDA’s statements about compounded versions of the pre-term birth drug Makena fall within its enforcement discretion and are exempt from judicial review, a federal judge ruled Sept. 6 in dismissing Lumara Health Inc.’s lawsuit against the agency.

In a 38-page opinion, Judge Amy Berman Jackson of the U.S. District Court for the District of Columbia said the agency’s public statements regarding compounded versions of hydoxyprogesterone caproate, or 17-P, are not subject to review in light of a 1985 Supreme Court ruling, Heckler v. Chaney, which held that FDA’s decision not to take enforcement action is within its discretion.

Furthermore, the agency’s March 2011 statement citing the conditions under which it would exercise its enforcement discretion on compounded versions of 17-P did not represent a formal statement of agency policy exempt from the protections of the Chaney case, Judge Jackson said.

The court’s ruling was not a surprise given Judge Jackson’s skepticism, expressed during an Aug. 7 hearing, regarding her authority to order FDA to take enforcement action against compounding pharmacies.

However, the decision is yet another blow to the beleaguered KV, which filed for bankruptcy protection in early August and has been pinning its hopes for financial recovery on being able to boost sales of Makena by eliminating the market for compounded versions of 17P. In addition to challenging FDA’s enforcement stance, KV has brought litigation against several state Medicaid agencies seeking to lift reimbursement restrictions on the branded drug Also see "Bankrupt KV Pharma’s Hopes For Makena Rest With Skeptical Judge" - Pink Sheet, 13 August, 2012..

A Presumption Of Unreviewability

KV sued FDA in July, seeking a court order forcing the agency to take enforcement action against pharmacies compounding 17P. At the heart of the lawsuit were FDA’s public statements issued in March 2011 and June 2012 on issues involving 17P compounding and the conditions under which it would exercise enforcement discretion Also see "Makena’s Orphan Exclusivity Is “Nullified” By FDA’s Compounding Policy, KV Suit Says" - Pink Sheet, 6 July, 2012..

During the hearing on FDA’s motion to dismiss the lawsuit, Judge Jackson repeatedly challenged KV’s counsel to explain how she could require FDA to take enforcement action given the precedent in the Chaney case. She also expressed concerns about becoming a “super law enforcement monitor” charged with overseeing the agency’s enforcement activities.

At the outset of her ruling, Judge Jackson found KV had standing to bring the lawsuit because FDA “has the means and the authority to bring enforcement actions that would likely decrease the incidence of unlawfully compounded 17P.”

Turning to the issue of reviewability, however, Judge Jackson agreed with FDA that KV’s claims fell within the presumption of unreviewability established in Chaney. In that case, the Supreme Court ruled that FDA’s refusal to prevent states from using certain drugs for lethal injection was not subject to judicial examination.

“This case is fundamentally an effort to get the Court to direct and oversee the FDA’s enforcement activities, and that it cannot do,” Judge Jackson said.

“Just as in Chaney, plaintiffs allege ongoing violations of substantive provisions of the FDCA, and they request that the Court order FDA to take investigatory and enforcement action to stop them,” Judge Jackson said. “A review of the extensive prayer for relief demonstrates that this case is fundamentally an effort to get the Court to direct and oversee the FDA’s enforcement activities, and that it cannot do.”

Congress did not express any intent in the Food and Drug Cosmetic Act to limit agency enforcement discretion, and it did not provide any law for the court to apply, the judge said. “Indeed, in their papers, plaintiffs did not point to any specific language in these statutory provisions that supposedly expressed the legislature’s desire to limit the agency’s enforcement discretion or that could serve as the guide for a court’s review. Moreover, when asked directly at the motions hearing, counsel for plaintiff would not concede the point, but he repeatedly failed to direct the Court to any statutory provisions that would satisfy the Chaney test and overcome the presumption.”

“Smack In The Middle” Of FDA Operations

The judge said that in an attempt to avoid the effects of Chaney, KV asserted it was not seeking a specific type of enforcement action.

“This distinction does not save the case,” the court said. “Plaintiffs’ request that the Court order ‘sufficient’ enforcement action to restore plaintiffs’ competitive advantage and that it monitor FDA’s activities by requiring regular reports demonstrate that they are asking the Court to get right smack in the middle of agency operations.”

The judge also rejected KV’s claims that the March 2011 statement was exempt from the effects of Chaney, and therefore reviewable, because it set forth a general enforcement policy, not a decision in an individual case.

However, the letter challenged in Chaney also involved a broad class of alleged violators, Judge Jackson said. “More important, the March Statement is neither the formal result of a rulemaking process nor a universal policy statement, so the limited circumstances that the D.C. Circuit said may call for a different result are not present here.”

Finally, the court said the last count of KV’s complaint, which alleged that FDA is wrongfully permitting the importation of foreign-made active pharmaceutical ingredient for compounded 17P, should be dismissed for failure to state claim.

FDA Compounding Statements Beyond Judicial Review; Court Tosses Makena Suit

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