FDA Sets New Rules to Combat Drug Shortages

The agency will require more notification of impending supply changes.

National Journal
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Sophie Novack
Oct. 31, 2013, 4:25 a.m.

The Food and Drug Ad­min­is­tra­tion is tak­ing meas­ures to fur­ther ad­dress the prob­lem of drug short­ages, The Wall Street Journ­al re­ports.

The FDA will share a new fed­er­al rule and plan on drug short­ages on Thursday, which will add to an or­der signed by Pres­id­ent Obama in 2011 and passed by Con­gress in 2012

The law will re­quire com­pan­ies to let the FDA know about any tem­por­ary man­u­fac­tur­ing situ­ations that would en­danger drug sup­ply, or of any plans to cease pro­duc­tion of drugs in short sup­ply. The agency would then find al­tern­ate man­u­fac­tur­ers to make the drug. 

The num­ber of no­ti­fic­a­tions of com­ing short­ages by com­pan­ies to the FDA in­creased six­fold since the pres­id­en­tial or­der in 2011, but doc­tors and re­search­ers say there is much still to do. 


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