In the remaining days of this divided Congress, one issue that is uniting policymakers is the need to improve our system for getting low-cost quality-assured therapies to patients quickly. Yet one proposal included in a Senate bill would impede that goal by exempting biologic medicines – including biosimilars, insulin, blood thinners, cancer treatments and other drugs – from having to comply with public standards for quality.
We are concerned about the impact that this Senate provision could have on patient safety and public health and believe that it would undermine medication quality and integrity in America. If enacted, this provision would make it more difficult for public health officials to test the quality of biologic drugs across the supply chain, hinder the development of biosimilars and thereby increase costs for payers, and remove the transparency and collaboration that now exist in standard-setting.
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