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Public quality standards for biologic drugs promote transparency and competition — don’t get rid of them

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A draft of the Lower Health Care Costs Act circulated by the U.S. Senate’s powerful Health, Education, Labor, and Pensions Committee includes a provision that would drastically change how the U.S. develops standards for the strength, quality, and purity of medicines, particularly cutting-edge biologics and biosimilars.

Unlike traditional small-molecule chemical drugs, like aspirin, manufactured using biochemical processes, biologics are large, complex molecules produced in living organisms. Thanks to breakthroughs in biotechnology, a diverse and growing list of biologics have been approved for sale in the U.S., broadening patients’ treatment options and opening new fronts against disease.

FDA-approved biologics range from therapeutic proteins (such as filgrastim), monoclonal antibodies (such as adalimumab), and vaccines (such as those for influenza and tetanus). Biosimilars are essentially generic versions of originator biologics, producing the same medical effect through a highly similar chemical structure.

Currently, biologics are required to adhere to public quality standards developed by the U.S. Pharmacopeia (USP), an independent non-profit that collaborates with hundreds of health and science experts. Its standards, which are set after a drug has been approved by the FDA, dictate the strength, purity, potency, and other characteristics of drug ingredients. The FDA and other federal agencies are responsible for enforcing the USP’s standards.

The proposal being floated in the Senate would remove the requirement that biologics and biosimilars sold in the U.S. conform to the USP’s public standards. The responsibility of developing quality standards for biologics and biosimilars would be transferred to the FDA, and important information about these products would no longer be available to health care providers and patients.

The USP’s standards are available to anyone, bolstering the public trust in the medicines we take. Public standards establish the parameters by which drugs can be evaluated regardless of the manufacturer or the source of ingredients. Unlike the private standards developed by drug makers, public standards allow anyone to test the quality of a drug anywhere along its supply chain. As manufacturing processes grow more complex and foreign suppliers play a larger role in providing medicines consumed by American patients, having a transparent quality standard has never been more important.

The proposal’s backers claim it would reduce drug costs and accelerate biologic and biosimilar innovation, but its real-world outcome would likely be the opposite. Public quality standards actually promote competition by creating a level playing field and facilitating the entry of products from multiple manufacturers.

In Europe, where biologic and biosimilar manufacturers are also required to comply with public quality standards, 51 biosimilars have been approved to date, compared to only 19 in the U.S. Public quality standards can hardly be blamed for America’s lagging position in biotech innovation.

Transferring standard-setting authority to the FDA — an agency already struggling to fulfill its core missions despite understaffing and budget cuts — would grow the federal bureaucracy without delivering any tangible benefits to Americans. The FDA is notoriously slow to develop guidelines and approve new therapies, and there is little reason to think its oversight of biologics’ quality standards would not suffer from similar delays.

Besides, while the USP fulfills its mission without taxpayer funding, expanding the FDA’s role would add to government expenditures and deepen the federal fiscal imbalance.

For nearly a century, through its transparent and scientifically-informed standards, the USP has helped ensure medicines sold in the U.S. are safe and effective. Its standards for biologic and biosimilar products are continuously revised and expanded to accommodate new breakthroughs and adapt to technological advances.

Ignoring this track record and disrupting the well-functioning system of which the USP is an integral part threatens to undermine the quality of medicines available to Americans. And for what?

Liam Sigaud works on economic policy and research for the American Consumer Institute, a nonprofit educational and research organization. 

Tags biopharmaceutical Biosimilar Biotechnology Food and Drug Administration Pharmaceutical industry

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