House Re­pub­li­cans ques­tion FDA's progress on phar­ma in­spec­tions in In­dia and Chi­na

Three of the top Re­pub­li­cans on the House En­er­gy & Com­merce Com­mit­tee on Tues­day sent a let­ter to FDA com­mis­sion­er Rob Califf ques­tion­ing the agency’s progress in ad­dress­ing wor­ri­some phar­ma and API man­u­fac­tur­ing fa­cil­i­ties in In­dia and Chi­na.

The let­ter comes as the FDA has grap­pled with se­vere short­ages of a com­mon can­cer drug thanks to the clo­sure of a site in In­dia. Ear­li­er this month, the agency al­so shift­ed how it’s pri­or­i­tiz­ing phar­ma-re­lat­ed in­spec­tions so that sites in In­dia and Chi­na take prece­dence over US- and EU-based sites, thanks to an up­dat­ed risk-based mod­el cre­at­ed by Con­gress.

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