FDA halts pediatric study of Amgen's Sensipar after death

Sensipar is a drug that got special price protections in fiscal cliff legislation
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The FDA has halted a study in children of the Amgen ($AMGN) drug Sensipar after a 14-year-old died during the trial. While the FDA says it does not know yet if the drug was the cause of the death, it halted the trial as a precaution. Sensipar stirred up ire last month when it was learned that the drug received special price protections in the fiscal cliff bill.

"Posting this information does not mean that FDA has concluded whether or not Sensipar had a role in the patient's death," the FDA said in a statement. "This communication is intended to inform health care professionals that we are evaluating the information and will communicate our final conclusions and recommendations when our review is complete." 

Amgen said it is "working as rapidly as possible to understand the circumstances of what happened," CBS News reported.

Sensipar was approved a decade ago for the treatment in adults of overactive parathyroid glands. Amgen initiated the new trial to see if the drug could be used for the same purpose in children.

Last month, Amgen hit the spotlight during the fiscal cliff fight, when The New York Times reported that a provision in a bill postponed new pricing rules for oral drugs used by patients on dialysis. Because most drugs for end-stage renal disease are injectable, the pill versions are a small group of products--a group dominated by Sensipar. The Times pointed out that Amgen is a big donor to several of the lawmakers who backed the delay and lobbied hard for the provision that was slipped into the fiscal cliff bill. Other drugs are subject to bundled payments, which were instituted because it was believed previous pricing rewarded providers to use more drugs. The discovery of the special deal for Amgen led to an immediate backlash.

Just last week, Amgen issued a statement defending the price protections, saying that "contrary to the implications of past media reports," an analysis by the Congressional Budget Office indicates that keeping current pricing for oral-only drugs will create savings for Medicare and taxpayers over time. 

- here's the FDA announcement
- read the CBS news story
- see the New York Times article
- here's Amgen's statement on Sensipar pricing

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Amgen's Sensipar scored pricing shield from Congress
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