Oba­macare de­bate snags phar­macy bill

The Washington Times Daily - - Politics - BY MATTHEW PER­RONE

A year af­ter a menin­gi­tis out­break from con­tam­i­nated pain in­jec­tions killed at least 64 peo­ple and sick­ened hun­dreds, Congress is ready to in­crease fed­eral over­sight over com­pound­ing phar­ma­cies that cus­tom-mix med­i­ca­tions.

Be­fore the bill gets to Pres­i­dent Obama for his sig­na­ture, it first has to clear a hur­dle put in its path by Sen. David Vit­ter, Louisiana Repub­li­can, in his on­go­ing cam­paign to dis­credit the pres­i­dent’s health care over­haul. A test vote is sched­uled for Tues­day evening.

The leg­is­la­tion, passed by the House in Septem­ber, also cre­ates a na­tional sys­tem for track­ing pre­scrip­tion drugs from man­u­fac­tur­ers to re­tail phar­ma­cies, first through se­rial num­bers on bot­tles and con­tain­ers and later through elec­tronic codes.

Al­though the bill en­joys nearly universal sup­port in Congress, Mr. Vit­ter has ob­jected to the Se­nate vot­ing on it without first vot­ing on his mea­sure to make mem­bers of Congress dis­close which of their aides are sign­ing up for the health care law, and which are in­stead be­ing al­lowed to re­main in the Fed­eral Em­ployee Ben­e­fit Pro­gram.

Mr. Vit­ter ob­jects to an Obama ad­min­is­tra­tion de­ci­sion ear­lier this year al­low­ing law­mak­ers to choose be­tween the two pro­grams for their aides, and di­rect­ing the govern­ment to pick up three-fourths of the pre­mium costs for mem­bers of Congress and their aides ei­ther way. Law­mak­ers them­selves have to switch to cov­er­age un­der the health care law. Mr. Vit­ter’s in­sis­tence on end­ing the em­ployer match ear­lier this year prompted Se­nate Democrats to scut­tle an en­ergy bill. The is­sue arose again in last month’s showdown over the govern­ment shut­down.

The com­pound­ing phar­macy bill is in­tended to avert a re­peat of last year’s menin­gi­tis out­break as­so­ci­ated with the now-closed New Eng­land Com­pound­ing Cen­ter. Sub­se­quent in­spec­tions found un­san­i­tary con­di­tions at the com­pany’s plant in Fram­ing­ham, Mass., in­clud­ing mold and stand­ing wa­ter.

Con­tam­i­na­tion prob­lems with com­pounded medicines have been re­ported for decades. But ju­ris­dic­tion over them has been murky. Phar­ma­cies are typ­i­cally reg­u­lated through state boards, but the Food and Drug Ad­min­is­tra­tion reg­u­lates man­u­fac­tur­ers of medicines.

The bill at­tempts to sort out that le­gal gray area which al­lowed the NECC and other phar­ma­cies to skirt both state and fed­eral reg­u­la­tions. The mea­sure clar­i­fies the FDA’s au­thor­ity to shut down phar­ma­cies that be­come so large they re­sem­ble man­u­fac­tur­ers, but it doesn’t re­quire those phar­ma­cies to reg­is­ter with the agency, a step that would have sub­jected them higher qual­ity stan­dards and in­spec­tions. In­stead, phar­ma­cies can vol­un­teer to be reg­u­lated by the FDA as a sort of op­tional “stamp of ap­proval.”

Still, pub­lic safety ad­vo­cates who lob­bied for the bill say it im­proves the sta­tus quo.

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