FDA Dodges Suit Over Makena Enforcement

     (CN) – KV Pharmaceutical cannot sue regulators to shut down cheaper, unapproved versions of its preterm birth drug Makena, a federal judge ruled.
     For years, compounding pharmacies have offered a drug that uses hydroxyprogesterone to reduce the risk of premature birth in pregnant women who have had a prior preterm birth.
     Though this treatment goes for about $20, KV Pharmaceuticals started charging $1,500 per injection for its drug when the Food and Drug Administration approved it in early 2011.
     KV lowered its price amid protests, but it complained in July that compounders were still selling the cheaper drug, known as 17P, without any repercussions from the FDA. Such unlawful competition allegedly caused KV to lose revenue and file for bankruptcy.
     The FDA and certain Medicaid programs favored the compounded versions because of public pressure about Makena’s price, according to the complaint.
     KV said this favoritism occurred even when the unapproved drugs were manufactured on a commercial scale, exceeding the scope of traditional compounding.
     In addition to its refusal to take enforcement action against compounders, except under certain circumstances, the FDA also failed to block imports into the United States of the active ingredient used in the compounded versions, according to the suit.
     U.S. District Judge Amy Berman Jackson found that KV had standing to sue since loss of profits because of unlawful competition is an injury that can be redressed.
     Enforcement would likely reduce the supply of compounded drugs on the market, compelling more health care professionals and insurers to prescribe and cover Makena, according to the ruling.
     And since most active ingredients used in the compounded versions are manufactured abroad, the FDA could limit the use of such ingredients by controlling imports, Jackson found.
     Despite its standing, however, most of KV’s claims are not reviewable because enforcement decisions fall within the FDA’s absolute discretion, the ruling states.
     “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,” Jackson wrote.
     The court cannot tell the FDA how to allocate its enforcement resources and when to take action against compounders, she added.
     What’s more, the FDA’s press release, which indicates that the agency may take enforcement action in some cases, is not a general policy statement subject to judicial review.
     “FDA’s March statement does not ‘consciously and expressly’ indicate that it will never bring enforcement actions against unlawful compounders, or that it will never bring enforcement actions against unlawful compounders of 17P,” Jackson wrote.
     A subsequent FDA press release clarified that the agency would take enforcement action if pharmacies exceed the scope of traditional compounding or if there are safety issues, using a risk-based approach.
     Jackson also rejected KV’s claim that the FDA violated the Food, Drug, and Cosmetic Act by allowing imports of the foreign-manufactured active ingredient used in the compounded drug into the United States. Here, KV had failed to point to a specific FDA policy that permitted the allegedly unlawful imports, she found.

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