Abandoning Quality Standards for Biologic Drugs Jeopardizes Patient Safety

Patient Confidence in Biologic Medicines

According to the Centers for Disease Control and Prevention (CDC) about one in 10 American adults has diabetes, and each day tens of thousands of Americans use insulin to help control their diabetes.  Before insulin was discovered in 1921, doctors could do little to help patients with diabetes, and the result often meant premature death. Since then insulin has increased the life expectancy of diabetics and dramatically improved their quality of life. 

Insulin from cattle and pigs was used to treat diabetes for many years and saved millions of lives, but it wasn’t perfect as it caused allergic reactions in many patients.  The first genetically engineered human insulin was produced in 1978 and thanks to decades of research and innovation, physicians and pharmacists now have access to a variety of formulas and ways to administer insulin based on their patients’ needs.

Given the importance and widespread use of insulin, we take for granted the high quality of this life-saving drug. When we, or a loved one, take insulin we do not need to worry that it is what it purports to be, that it is free of contaminants, that it is the correct dosage, and that it is packaged, labeled and stored in a manner that ensures the medication will work as intended. We can be confident because medicines sold in the U.S. must meet standards for quality set and continuously revised by the United States Pharmacopeia (USP).

That confidence could be eroded by legislation Congress is considering that will remove the requirement that all biologic medicines – drugs such as insulin, vaccines, cancer treatments and many other therapies that are made using living matter – comply with critical quality standards.  This policy would overturn a proven 100-year old framework that has made the U.S. medicines supply among the safest in the world. If enacted, we would be unable to have the same peace of mind and confidence in insulin or other biologic medicines going forward. The public’s confidence in biologics and patient safety would be placed at risk.

Since 1906, federal law has required that all prescription medications meet public quality standards to be legally marketed in the U.S. These quality standards are developed through an open, transparent process and that allows for independent determination of a medicine’s quality, regardless of who makes it or how it is manufactured. This is why it is especially important that we have public standards in place that can be used by regulators across the pharmaceutical supply chain to test for quality as medicines move through the increasingly complex global supply chain to patients. These requirements are especially important for sensitive biologics, such as insulin, which are administered by injection or infusion. 

The legal framework to ensure medicine quality, dating back to 1938 and repeatedly upheld in revisions of the law, has required compliance with the quality standards and requirements set by USP.  The process to develop these standards includes a wide array of scientific and public health experts who develop them working alongside the U.S. Food and Drug Administration which approves new drugs before they come on the market.  USP standards evolve to keep pace with scientific advances; as such, they have remained a constant in terms of safeguarding the quality of American medicines over the past century. 

As an organization committed to patient access to high quality medicines and to assuring the integrity of the U.S. medicine supply, we urge Congress to maintain the system that ensures the quality of all prescription drugs, including biologics. Specifically, as the Senate is drafting its version of the House-passed 21st Century Cures Act, we urge that the current framework for setting standards for U.S. medicines remains intact.  

It is essential that healthcare providers, including physicians and pharmacists, and patients themselves trust that the innovative and biosimilar medicines available in the U.S. are of high quality. Dismantling quality standards and allowing biologic drugs to bypass crucial requirements threatens to destroy confidence in prescription drugs and endangers the health and safety of those we work every day to protect.

 

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