USA – 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