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USP’s Generics Access Plan to Aid FDA Efforts

Posted 04 February 2019 | By Zachary Brennan 

USP’s Generics Access Plan to Aid FDA Efforts

USP last week unveiled a new Generic Access Plan as part of its collaboration with the US Food and Drug Administration (FDA) to better facilitate generic drug competition.
As part of the plan, USP has pledged to develop and update quality standards supporting FDA’s Drug Competition Action Plan (DCAP), which includes a list of off-patent drugs for which there are no generic alternatives.

“Manufacturers can rely on USP quality standards, helping accelerate availability of generic versions of off-patent medicines,” said USP CEO Ronald Piervincenzi. “This helps provide patients more access to affordable alternatives of the medicines they need.”
USP standards can help to protect the quality of medicines, such as by assessing their identity, strength, purity and dissolution.
Most recently, quality standards have been updated for the antiparasitic/antiviral nitazoxanide, desvenlafaxine and the antibiotic vancomycin, which according to a USP spokesperson was revised to accommodate a new formulation that does not require the drug to be frozen, making it more useful for public health uses. Two other cancer medicines were also included in the updates.
“The reasons for revisions vary and include everything from simply adding a new dissolution test, accommodating a new formulation, working concurrently with the manufacturer’s application to FDA to prevent a compliance gap, to revisions to accommodate new methods or techniques – that make our standards more flexible for people to use,” USP spokesperson Anne Bell told Focus.
USP and FDA also work collaboratively on training and education sessions, occasionally to help ensure adequate training is in place to support FDA guidance. USP also holds international training sessions. For instance, on Tuesday, there is a workshop on Biologics and Peptides in Hyderabad, India. And in March, USP and the European Directorate for the Quality of Medicines will host an International Reference Standards Symposium in Strasbourg, France.
As far as FDA and USP work on DCAP, Bell told Focus: “We have had ongoing conversations with the agency on the role of USP and compendial standards in support of DCAP since the FDA first announced the program.
“We are working to advance FDA’s DCAP initiative in two main ways: as a scientific standard-setting body and as a convener of conversations with stakeholders. We are identifying monographs that would need to be revised or developed to support the FDA’s off-patent, off-exclusivity list. And, as part of determining priorities, we are meeting with stakeholders (patient advocacy groups, health policy leaders, industry, and more) to get further input to identify challenges and to prioritize based on public health need,” she added.


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