A powerful committee in the U.S. Senate is considering legislation that could have significant negative effects on Mainers seeking treatment from cutting-edge drugs.
The measure would remove the existing requirement that a biologic or biosimilar product sold in the U.S. adhere to public standards, called monographs, set by the U.S. Pharmacopeia (USP), an independent non-profit organization that has helped protect the quality of American drugs for more than a century. The USP’s standards dictate the purity, potency, and other characteristics of drug ingredients.
The class of products under scrutiny, biologics and biosimilars, are large, sophisticated molecules produced in living organisms. Over the last few years, a diverse and growing list of biologics — including medicines to treat arthritis, cancer, and diabetes — have been approved for marketing in the U.S. Biosimilars are essentially generic versions of originator biologics.
The proposal’s backers, including the FDA and the Trump administration, argue that while USP standards make sense for small-molecule chemical drugs like aspirin, “a biological product is so inherently complex and variable that the established structure of the USP…standards process does not serve it well, and in fact, can impede technological progress or innovation” by failing to accommodate future advances in manufacturing techniques.
But there’s little evidence to support the FDA’s claims. Since the USP’s standards aren’t developed until the first originator biologic comes to market, they don’t interfere with innovation. For companies seeking to develop biosimilars once an originator biologic has been created and a monograph is in place, the USP’s standards help more than they hinder, giving drug makers clarity about how to design their research and development 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, reject the FDA’s arguments.
The USP has a long record of adapting quickly to evolutions in scientific knowledge and regulatory practices. This year alone, more than 800 experts are participating in USP standards-setting committees that continuously revise quality benchmarks and manufacturing requirements based on the latest research. The USP’s standards for insulin products, for example, have been frequently updated since their introduction in 1941 to accommodate shifts in manufacturing techniques and biotechnology. Moreover, the USP has already demonstrated its commitment not to publish new biologic standards without the FDA’s support and collaboration.
The FDA’s assertions are also undermined by the fact that in Europe, where manufacturers of biologics and biosimilars are also required to comply with public quality standards, 51 biosimilars have been approved to date, compared to only 20 in the U.S. It’s clear that thriving biosimilar competition is compatible with robust public standards.
And there’s reason to think the plan could backfire. Instead of spurring innovation and cost savings, it could unravel decades of work meant to ensure the safety and quality of biologics.
The quality benchmarks in the USP’s public standards allow for independent verification that a medicine has been made properly, regardless of the manufacturer or manufacturing process. In doing so, the USP’s public standards give health care providers that prescribe and administer biologics, as well as the patients who count on them for treatment, confidence in the products they use.
Without the USP’s public standards, the public, practitioners, and the rest of the stakeholder community in the dark about the standards governing how these vital medicines are produced. Only drug manufacturers and a handful of federal bureaucrats would be familiar with the details, making it harder to hold companies accountable.
Mainers should have confidence that the medicines they take are made to the highest possible quality standards. For more than a century, the USP has helped make that possible. As global manufacturing supply chains grow more complex, public quality standards for biologics have never been more important.
Liam Sigaud works on economic policy and research for the American Consumer Institute, a nonprofit educational and research organization. He lives in Rockland, Maine.
