Generic medicines have benefited millions of Americans and saved $1.5 trillion over the past 10 years. While there has been much progress, there are many off-patent medications that still have few or no generic alternatives. USP’s Generics Access Plan can help increase patient access to medicines by facilitating generics competition through:
- New and revised quality standards
- Training and education
- Collaborations with the U.S. Food and Drug Administration (FDA), industry representatives, and others
USP is committed to helping increase patient access to medicines by facilitating competition. The Generics Access Plan includes:
- Support of FDA’s Drug Competition Action Plan (DCAP) priorities, including FDA’s list of off-patent drugs for which generic alternatives are not available on the market
- Offering training and education for generics manufacturers worldwide on best practices for applying quality standards to enhance the capabilities for producing quality generics
- Convening regulators, industry representatives, patient groups, payers, healthcare practitioners and others to identify additional ways to support generics development through the standard-setting process and educational programming
How are quality standards used?
USP standards help protect the quality of medicines in a number of ways, including helping to assess their identity, strength, purity and dissolution. Written standards (also called documentary standards) provide specifications to confirm:
- Identity: it is what it claims to be
- Strength: it has the right amount of the active ingredient
- Purity: it does not have harmful levels of known impurities
- Dissolution: It disintegrates and dissolves in the body so the active ingredient can be absorbed
Reference standards (also called physical standards) are small vials of highly characterized chemical substances used for comparing test results to assess the quality of drugs and their ingredients.
Public quality standards can help facilitate more generic competition and increase the number of generic medicines available to patients
USP standards apply to drug products sold in the U.S. to help ensure we can trust the quality of medicines. Many of these standards are for drugs used to treat chronic health conditions like high blood pressure, high cholesterol, seizure disorders, mental health conditions, diabetes and other major health concerns.
USP standards provide generics manufacturers around the world with publicly available requirements and testing methods, as well as expectations for quality. Those same standards can help manufacturers develop generic versions of off-patent drugs. And without these public standards in place, it could be more difficult for some manufacturers to bring generics to market.