USP launches its Generics Access Plan

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USP launches its Generics Access Plan

By Sandra Levy - 02/01/2019
USP, a scientific non-profit that develops public quality standards for drugs, is looking to use standards to facilitate generic drug competition. The organization on Friday unveiled its Generics Access Plan, which is meant to bring more generics to market through new and revised quality standards and related activities, including collaborations with the Food and Drug Administration and others.

USP said its Generics Access Plan supports the FDA in its efforts to encourage the development of new generics to help reduce drug prices and improve access to medicine for Americans through increased competition.

"Millions of Americans have benefitted from generic medicines and in just the last 10 years $1.5 trillion have been saved, yet there are still many off-patent medications that have few or no generic alternatives," USP CEO Ronald Piervincenzi said. "While there has been much progress, there are still many off-patent drugs that have limited or no generic options. We must close this gap, which is why USP is committed to doing our part by developing new public standards and processes, working with the FDA and others to facilitate greater access to important drug therapies."

USP's standards have helped drug manufacturers develop generic versions of off-patent drugs. Many of these standards apply to drugs used to treat chronic health conditions like high blood pressure, high cholesterol, seizure disorders, mental health conditions and other major health concerns. Without public standards in place, it could be more difficult for some manufacturers to bring generics to market.

"Manufacturers can rely on USP quality standards, helping accelerate availability of generic versions of off-patent medicines," said Piervincenzi. "This helps provide patients more access to affordable alternatives of the medicines they need."

USP's Generics Access Plan can help increase patient access to medicines by facilitating competition through new and revised standards, training and education, and collaborations with the FDA, industry representatives and others. The plan includes:

  • Developing and updating quality standards supporting FDA's Drug Competition Action Plan priorities, including FDA's list of off-patent drugs for which generic alternatives are not available on the market. USP is prioritizing development of new public quality standards to help facilitate generic medicines in a number of therapeutic areas, including for medicines used to treat hypertension, seizure disorders, HIV and cancer; and

  • Offering training and education for generics manufacturers worldwide on best practices for applying quality standards to enhance the capabilities for producing quality generics.