The Push for Additional Orphan Drugs Can the FDA Do More to Encourage Their Development?

Stephen Barlas

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The Push for Additional Orphan Drugs Can the FDA Do More to Encourage Their Development?

机译：额外的孤儿药物的推动可以让FDA做得更多，鼓励他们的发展？

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AstraZeneca's failed attempts to convince the Food and Drug Admin-Mstration (FDA) and a federal court to require extra labeling on the slew of generic versions of Crestor that became available this summer illustrate the lengths to which brand-drug companies will go to protect orphan drug prices and profits. In May, the FDA approved AstraZeneca's Crestor (rosuvastatin calcium) as a treatment for a rare condition called homo-zygous familial hypercholesterolemia (HoFH). As a result, AstraZeneca gained seven-year orphan market exclusivity for Crestor for that indication. Its broader patent expired in July. Then AstraZeneca tried to force the FDA and a U.S. District Court to require the agency to mandate that the new Crestor generics include pediatric HoFH labeling that would prevent safety problems if physicians prescribed generic Crestor off-label for pediatric HoFH. The agency and a judge rejected AstraZeneca's demand. Other brand-drug companies have tried unsuccessfully to use the same tactic.

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《P & T: a peer-reviewed journal for formulary management》 |2016年第11期|共10页
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Stephen Barlas;
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Washington D.C.;

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正文语种 eng
中图分类药学;
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The Push for Additional Orphan Drugs Can the FDA Do More to Encourage Their Development?

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