FDA Bolsters Generics Push with Updated List, USP Partnership


The administration has given its first update to a recently drafted off-patented, off-exclusivity list of drugs without approved generics.

fda, generics, guides, list, off-patent, USP

The US Food and Drug Administration (FDA) has published an update to its list of off-patent, off-exclusivity drugs without any approved generics to better clarify its presented information to aid potential generic developers researching products.

The FDA has maintained the list to promote transparency, development for, and submission of generic drug applications in markets and for conditions with limited options.

The list (originally published June 2017) was categorized by drug product instead of active ingredients. It also now displays dosage forms for all the list drug products, and has added products not initially identified in the previous version, as well as products that have lost exclusivity since the list’s first version.

As part of the update, the FDA will now work with the US Pharmacopeial Convention (USP) to maximize the utility of the potential generics list, by allowing the nonprofit organization to use the list as a reference to determine drugs to advance the development of generic medicines for.

The FDA noted in a statement that the USP, of which they have had a working partnership with since 2010, has standards that have “long been used by generic firms as a way to guide their drug development.”

In recent months, the FDA has expressly pushed efforts to broaden its generics market and application process. Commissioner Scott Gottlieb, MD, said it’s important for the administration to provide tools and resources that increase competition in the prescription drug market. The updated list is just one of such tools.

“Today we’ve made key changes to that list, including presenting the information more clearly by drug product instead of by active ingredient so companies can more easily identify products for potential development where competition is needed,” Gottlieb said.

Gottlieb added that the USP partnership could assist in proving useful and clear information for the generic drug industry, “to help encourage development of important generic medicines and increase access for patients.”

The updated list and partnership are just the most recent in a running series of FDA campaigns to improve the generics market. Coupled with the original version of the off-patent, off-exclusivity list, the administration implemented a first-time policy that expedites limited-competition generics’ application reviews in June.

The FDA then introduced new draft guidance for pre-abbreviated new drug application (ANDA) meeting requests in October. The guidance allows the FDA to provide more useful advisory to manufacturer developing complex generics.

It’s been a booming market for FDA-approved generics. From May through September of this year, the administration approved nearly 73 new generic products every month.

The administration intends to continue to refine and periodically update the off-patent, off-exclusivity list to identify drug products where increased competition has the potential to provide significant benefit to patients.

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