Study: USP quality standards support U.S. generics market

A new study released in the journal PLOS One found that on average, drugs with a public quality standard developed by the U.S. Pharmacopeia had approximately 50% more generic manufacturers compared with medicines without such a standard.

Researchers from Johns Hopkins University, who developed the study, "Association Between USP Monograph Standards, Generic Entry and Prescription Drug Costs," concluded that quality standards helped facilitate pharmaceutical competition and reduce prescription drug costs in the United States.

Public quality standards for medicines, also known as monographs, which are developed by USP, set specifications for purity, potency and other quality attributes, which assist generic manufacturers in more efficiently gaining regulatory approval for drug products. Researchers estimated these standards increased competition in the generic medicines market and reduced overall prescription drug costs by $11 billion in 2015 and 2016.

"Mandatory, public quality standards have played a critical role in building the public's trust and confidence in medicines and have helped make America's drug supply among the safest in the world," said USP CEO Ronald Piervincenzi. "While we have long had anecdotal evidence about how our work positively impacts access to medicines, the Johns Hopkins study is the first to provide data on the economic benefits of mandatory public quality standards and links USP monographs to increased market competition and lower drug prices."

The Johns Hopkins study provides evidence in support of USP's Generics Access Plan, which launched in January to help increase access to medicines by facilitating generic competition through new and revised quality standards and related activities. USP's Generics Access Plan supports the FDA in its efforts to encourage the development of new generic medicines to promote competition, help reduce drug prices and improve access to medicines for Americans.

USP develops science-based quality standards, and adherence to them is required for all corresponding drug products marketed in the United States regardless of where in the world they are manufactured. A network of over 800 scientists and other experts from around the world volunteer their time and expertise to develop the standards through a collaborative, transparent process. Once developed, the standards are available publicly and relied upon by healthcare professionals, regulatory and enforcement agencies, manufacturers and others. The starting point for the development of a drug monograph is often a donation of scientific methods for materials from a pharmaceutical manufacturer.

"As this and future studies corroborate the savings achieved through the availability of USP monographs, we also want the manufacturing industry to recognize the important role they play in donating their scientific methods to create standards that improve access to quality medicines," said Piervincenzi. "We want to build on the collaborative process of public standards development to bring critical therapies to patients by ensuring a robust generic market."