Maine leads the nation in promoting the development of drugs that expand access and reduce costs for patients. Unfortunately, a measure before Congress could have significant negative effects on Mainers seeking treatment from cutting-edge medicines.

An influential U.S. Senate committee is considering legislation that would exempt manufacturers of biologic and biosimilar drugs – including therapies for arthritis, cancer and diabetes – from meeting public quality standards set by the U.S. Pharmacopeia, an independent nonprofit organization that has helped protect the quality of American drugs for more than a century.

The U.S. Pharmacopeia’s public standards allow for independent verification that a medicine has been made properly, regardless of the manufacturer or manufacturing process. As global supply chains grow more complex, it’s important for providers and patients to have confidence in the products they use.

If the U.S. Pharmacopeia’s role in crafting these standards is ended, only drug manufacturers and a handful of federal bureaucrats will be familiar with the details of how biologics are produced, making it harder to hold companies accountable.

While the Food and Drug Administration and the Trump administration claim the U.S. Pharmacopeia’s standards impede biosimilar innovation and stifle competition, the evidence actually shows the opposite. Since the organization’s monographs aren’t developed until after the first originator biologic comes to market, they don’t interfere with innovation.

And for companies seeking to develop biosimilars once an originator has been created, the U.S. Pharmacopeia’s standards give drug makers clarity about how to design their manufacturing processes and gain regulatory approval. That explains why a leading biosimilar industry group, the Association for Accessible Medicines, along with a host of patient advocacy groups, rejects the FDA’s arguments.

Getting rid of mandatory public standards for biologics would undermine public trust and jeopardize the quality of medicines available to patients here in Maine, without tangible benefits to consumers.

Liam Sigaud

economic policy and research manager, American Consumer Institute; former policy analyst, Maine Heritage Policy Center


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