Pub­lic Cit­i­zen picks apart Cures 2.0 draft leg­is­la­tion, crit­i­ciz­ing sev­er­al RWE pro­vi­sions

Con­sumer ad­vo­ca­cy or­ga­ni­za­tion Pub­lic Cit­i­zen on Thurs­day sent a let­ter to con­gres­sion­al lead­ers, seek­ing changes to a key piece of leg­is­la­tion that will cre­ate new FDA re­forms if it’s en­act­ed.

The or­ga­ni­za­tion took par­tic­u­lar is­sue with the bill, which is the sec­ond it­er­a­tion of the mam­moth 21st Cen­tu­ry Cures Act or Cures 2.0, as it would in­crease the FDA’s re­liance on re­al-world ev­i­dence in cer­tain cir­cum­stances, such as ver­i­fy­ing the clin­i­cal ben­e­fit of drugs fol­low­ing ac­cel­er­at­ed ap­provals. Pub­lic Cit­i­zen said that would:

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