A controversial provision of the Senate HELP Committee’s Lower Health Care Costs Act would trigger an unprecedented rollback of existing law that puts patient safety at risk.
The provision, Section 207, would dismantle the quality framework that protects biologic medicine quality, ending transparency about biologic medicine quality and stifling innovation for critical and life-saving medications.
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The provision would strip away the requirement that biologic medicines adhere to public quality standards – critical to building trust in medicines.
The provision would also remove independent scientific experts from the standards process and allow quality standards for these vital medications, like those that treat diabetes, cancer and autoimmune disorders, to be kept secret by the government.
Keeping these standards privately held by the government would leave physicians, pharmacists, patients and the public in the dark.
This provision is all risk with no benefit.
