U.S. Pharmacopeia (USP) is committed to support FDA’s List of Off-Patent, Off-Exclusivity Drug Products without an Approved Generic (OPOE) to expedite greater access for important generic drug therapies and help ensure quality and scientific rigor during drug development and manufacturing. We recognize that the pharmaceutical manufacturing industry, FDA, public health community (patient organizations and healthcare practitioners) and USP all share a collective priority to expand patient access to safe, quality medicines. Through initial discussions with these key stakeholders, USP has prioritized FDA’s OPOE list, and launched a Call for Collaboration to advance our shared priorities.
As an organization committed to patient access to quality medicines, we invite you to participate in the Call for Collaboration. The Call for Collaboration bridges the voice of the patient with the scientific and technical capabilities of FDA, USP and pharmaceutical manufacturers.
Successful implementation includes:
- Active engagement and communication with the patient community and their advocates who identify gaps in access to critical therapies
- Regular dialogue with USP’s scientific staff
- Support for the pharmaceutical manufacturers efforts to develop new generic medicines from the OPOE list
USP has monitored the OPOE list to identify opportunities where public quality standards can help increase access to high impact public health medicines. We mapped our monograph development work, prioritized and identified areas where compendial standards can help increase access to quality medicines. Based on feedback from stakeholders, we developed a tiered approach to prioritize more than 450 drugs on the OPOE list, starting with candidate drugs that would have the greatest immediate impact. Join the collaboration to advance shared priorities and explore how our monograph development efforts can facilitate greater patient access to quality medicines.
Join the Call
The Call for Collaboration brings together USP, FDA, the patient advocacy community and pharmaceutical manufacturers who are committed to create quality generic medicines for legacy drugs without alternatives. Join us in this collective public health effort to increase access to quality medicines for patients who need them.
For more information: CallforCollaboration@usp.org