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 charges $1,500 per injection for its drug, which the Food and Drug Administration approved in early 2011.
It complained in July, however, that compounders continued selling the cheaper drug, known as 17P, without any repercussions from the FDA. KV Pharmaceuticals said the unlawful competition caused it to lose revenue and file for bankruptcy.
The FDA and certain Medicaid programs allegedly favored the compounded versions because of public pressure about Makena's price, according to the complaint.
KV Pharmaceuticals 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 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.
Read more: http://www.courthousenews.com/2012/09/20/50493.htm
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 charges $1,500 per injection for its drug, which the Food and Drug Administration approved in early 2011.
It complained in July, however, that compounders continued selling the cheaper drug, known as 17P, without any repercussions from the FDA. KV Pharmaceuticals said the unlawful competition caused it to lose revenue and file for bankruptcy.
The FDA and certain Medicaid programs allegedly favored the compounded versions because of public pressure about Makena's price, according to the complaint.
KV Pharmaceuticals 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 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.
Read more: http://www.courthousenews.com/2012/09/20/50493.htm
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