To accelerate generic competition, USP unveils generic access plan

By PharmaCompass

2019-02-07

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USP, short for United States Pharmacopeial Convention, announced its Generics Access Plan last week, as part of its collaboration with the FDA to better facilitate generic drug competition.

The plan will help increase access to medicines by facilitating generics competition through new and revised quality standards and related activities, including collaborations with the FDA and others. “USP standards can help protect the quality of medicines, such as by assessing their identity, strength, purity and dissolution,” a statement said.

USP, a scientific non-profit, develops public quality standards which apply to drug products sold in the US. These standards provide generics manufacturers around the world with publicly available requirements and testing methods, as well as expectations for quality, which can help them develop generic versions of off-patent drugs.

“Millions of Americans have benefitted from generic medicines and in just the last 10 years US$ 1.5 trillion have been saved, yet there are still many off-patent medications that have few or no generic alternatives,” Ronald T. Piervincenzi, CEO of USP said. “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 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 (DCAP) priorities, including FDA’s list of off-patent drugs for which generic alternatives are not available on the market.

FDA to improve utility of Orange Book: For generic drug companies, one of the most fundamental and crucial tools in planning their development efforts is the FDA publication — Approved Drug Products with Therapeutic Equivalence Evaluations Publication (commonly known as the Orange Book). This is a list of drug products approved by the FDA under the Federal Food, Drug, and Cosmetic Act. It includes information about patents and their exclusivity and identifies whether a drug is currently being marketed or has been discontinued.

In order to maintain an up-to-date Orange Book, the FDA announced several new steps to ensure that it provides the highest benefit to patients and providers, and generic drug developers. This includes a new draft guidance that provides approved drug application holders with clarity on the specific categories and descriptions of the information they’re required to share with the FDA on the marketing status for their brand and generic drugs and how to provide it in a timely and consistent manner.

“We want to make sure it provides as much utility as possible to aid manufacturers as they allocate resources towards the development of new generic drug products,” Gottlieb said.

Calling the Orange Book update a “transparency initiative,” FDA expects this undertaking will provide greater certainty around timing of market entry and enable more informed decisions.

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