Court sides against US agency in drug case


The maker of a pre­scrip­tion fish-oil pill won an early vic­tory Fri­day against the U.S. Food and Drug Ad­min­is­tra­tion (FDA) over its right to pub­li­cize un­ap­proved uses of its drug.

The pre­lim­i­nary rul­ing in U.S. Dis­trict Court could strengthen the phar­ma­ceu­ti­cal in­dus­try’s abil­ity to dis­trib­ute in­for­ma­tion about drug uses that have not been cleared by the FDA. That is­sue has been con­tested for years by the FDA and the com­pa­nies it reg­u­lates.

Ac­cord­ing to Fri­day’s de­ci­sion, Amarin has the right to give doc­tors truth­ful in­for­ma­tion about non-ap­proved in­di­ca­tions of its drug Vas­cepa, which is used to lower a cer­tain kind of fat.

The FDA has 60 days to ap­peal the rul­ing. A spokes­woman for the agency de­clined to com­ment on the rul­ing.

Drug­mak­ers are not al­lowed to ad­ver­tise drugs for “off-la­bel” uses, or those that have not been cleared by the FDA as safe and ef­fec­tive. But com­pa­nies’ abil­ity to dis­trib­ute in­de­pen­dent ma­te­ri­als about their drugs — such as med­i­cal jour­nal ar­ti­cles — has been sub­ject to years of le­gal de­bate.

The FDA ap­proved Vas­cepa in 2012 for pa­tients with ab­nor­mally high lev­els of triglyc­erides, a type of fat found in the blood­stream. But the agency re­jected a sec­ond use that would have al­lowed the com­pany to mar­ket the pill to pa­tients with lower triglyc­erides who also take statins — drugs used to lower choles­terol. The agency said the com­pany needed to sub­mit more data on whether low­er­ing triglyc­erides ac­tu­ally trans­lates into fewer heart prob­lems in those pa­tients. And FDA reg­u­la­tors sug­gested that dis­tribut­ing in­for­ma­tion about the al­ter­nate use would be illegal.

Amarin re­sponded in May with a pre-emp­tive law­suit, ar­gu­ing that FDA ef­forts to stop the com­pany from shar­ing “off-la­bel” in­for­ma­tion would vi­o­late the com­pany’s free speech pro­tec­tions. Judge Paul En­gel­mayer agreed in a 71-page opin­ion.

“Amarin may en­gage in truth­ful and non-mis­lead­ing speech pro­mot­ing the off-la­bel use of Vas­cepa,” states the opin­ion, re­leased Fri­day.

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