July 10, 2019
“One of the top priorities of the FDA is taking steps under our Drug Competition Action Plan to foster generic drug development and market entry, and to address potential impediments to drug competition to help support the Administration’s efforts to lower drug prices for Americans,” said Acting FDA Commissioner Ned Sharpless, M.D. “One area we’ve been working on involves working with the U.S. Pharmacopeial Convention (USP) to modernize small molecule compendial standards that have long been used by generic firms as a way to guide their drug development processes. Based on this collaboration, the USP and the FDA have developed a time-saving process that cuts out the waiting period for pending monograph decisions by allowing companies to propose revisions to a USP monograph while their application is still pending. This process is described in a guidance we’re announcing today. This effort will expedite USP small molecule monograph updates, immediately following FDA approval, potentially allowing generic medicines to come to market faster. We’re also advancing a guidance that explains how industry can use our inactive ingredient database to identify inactive drug ingredients that have previously been used in FDA-approved drug products. This may help facilitate a less extensive toxicology evaluation by the applicant and less extensive review by the agency the next time the inactive ingredient is included in a new drug application, again reducing unnecessary waiting time to bring generic drugs to market.”
Today, the U.S. Food and Drug Administration announced a draft guidance, Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process (USP-PMP), which explains the FDA-related aspects of a process where drug applicants and drug master file holders can propose the development of a new monograph or suggest revisions to an existing USP monograph during the FDA’s evaluation of a product application or drug master file. Under the Federal Food, Drug, and Cosmetic Act, drugs must comply with applicable compendial standards, including USP and National Formulary standards, or be labeled to show all respects in which the drug differs from compendial standards. Prior to the USP-PMP, if a monograph needed to be revised to include the applicant’s proposed specifications, there could be delays of six months or more before the revised USP monograph became official. The USP-PMP was developed to address the issue which will help prevent potential approval delays due to USP monograph noncompliance. The process is described further in the USP Pending Monograph Guideline.
When the Generic Drug User Fee Amendments (GDUFA II) were reauthorized, the FDA committed to enhancing the Inactive Ingredient Database by October 1, 2020. The draft guidance, Using the Inactive Ingredient Database, provides information on how industry can use the database and how it relates to application filing and scientific review decisions. The FDA has also created a docket so the public has an opportunity to comment before the database enhancements are completed.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.