Quality standards for biologics protects patient safety — don’t make it optional

For over 100 years, the framework to safeguard the quality and safety of medicines in the United States has been based on the principle that transparent expectations for quality must be clearly articulated through public standards and required under the law. This framework leaves no room for a lack of clarity about what constitutes quality — ensuring that manufacturers are meeting expectations consistently and that quality is not optional.

But a controversial provision tucked deep inside the “Lower Health Care Costs Act” currently being considered by the Senate HELP Committee would overturn this system for the biologic medicines our loved ones take every day and present significant risks to patient safety.

Specifically, this provision would make adherence to public quality standards optional for all of lifesaving biologic products, including insulin, jeopardizing medicine uniformity and quality, which threatens patient safety for Americans with conditions as diverse as diabetes, hepatitis and hemophilia.

When it comes to our families’ health, adherence to standards that help protect patient safety should never be optional.

The provision would represent a shift from providing the public with access to the expectations for a quality biologic medicine, to keeping specifications private between only the manufacturer and the regulator that grants market approval.

This is wrong. The public deserves transparency on the quality of biologic medicines.

As an example of the crucial need for public quality standards for biologic medicines, the United States Pharmacopeia (USP) first began developing public standards for insulin in 1955. Today, USP provides purity and potency specifications for most insulins currently marketed in the U.S., allowing for quality insulin and careful titration of each dose to promote good long-term disease management and patient safety. These significant quality measures can mean the difference between life or death for an American living with diabetes.

Adherence to transparent mandatory public quality standards is essential for ensuring the quality of biologics. They facilitate trust in medicines among patients and health-care providers, underpinning the confidence essential for physician prescribing, pharmacist dispensing and patient adoption of new therapies.

That’s one of the reasons prominent groups representing patients and health-care providers, like the American Diabetes Association, the Biosimilars Council at the Association for Accessible Medicines, the American Pharmacists Association, AARP and others, are all urging the Senate to stand up for patients and reject this provision.  

For biologic medicine manufacturers, public standards are frequently used to support product development, manufacturing and distribution. This provision would mean that manufacturers would have less clarity on the regulatory pathway, increasing redundancies and reducing predictability, potentially limiting patient access to needed new therapies and adversely impacting the affordability of crucial medicines.

Health-care providers and patients trust the biologic medications they prescribe and use because they have gone through a proven system where public quality standards are foundational to ensuring their quality. This framework has helped make biologic medicines in the United States among the safest in the world. The Senate should not be undermining it.

In the last Congress, a similar provision generated substantial controversy during consideration

of the 21st Century Cures Act and was rejected once the significance of the provision, in undoing important precedent and patient safety protections, became broadly understood.

At a time when we need to build the public’s trust in medicines, we need more transparency, not less. The Senate should once again reject this provision and stand up for patient safety.

Ronald T. Piervincenzi, Ph.D., is chief executive officer of U.S. Pharmacopeia, an independent, nonprofit, nonpartisan scientific organization that sets quality standards for medicines. USP also advocates for public and transparent quality standards to protect patient safety.