GAO says FDA's al­lowance of phar­ma­cies to dis­pense abor­tion pill was not sub­ject to con­gres­sion­al re­view

The US Gov­ern­ment Ac­count­abil­i­ty Of­fice con­clud­ed on Thurs­day that the FDA’s de­ci­sion to al­low cer­tain phar­ma­cies to dis­pense the abor­tion pill mifepri­s­tone is not sub­ject to con­gres­sion­al re­view.

The FDA mod­i­fied mifepri­s­tone’s risk eval­u­a­tion and mit­i­ga­tion strat­e­gy (REMS) in Jan­u­ary to per­mit cer­tain cer­ti­fied phar­ma­cies to of­fer Dan­co Lab­o­ra­to­ries’ brand-name Mifeprex pills and a gener­ic man­u­fac­tured by Gen­Bio­Pro. Pre­vi­ous­ly, pa­tients were re­quired to re­ceive the drug in a clin­ic, med­ical of­fice or hos­pi­tal.

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