New Guidance May Speed Generic Approvals

The US Food and Drug Administration (Rockville, MD) released a new draft guidance thisweek that may speed generic approvals. The guidance, ANDAs:Impuritiesin Drug Products, describes the degradation-product informationthatgeneric drug manufacturers should include in their abbreviated new drugapplications (ANDAs). This clarification, FDA officials say, will helpcompanies submit the correct information, thus increasing thelikelihood that their generic drugs will be approved, and approved morequickly.

"Deficiencies related to impurity specifications probably occur moreoften than any other deficiency in applications we see," says GaryBuehler, director of FDA's Office of Generic Drugs (OGD). Thosedeficiencies result in a lot of "back-and-forth" discussions, Buehlersays, between the agency and the sponsor company. Such dialogue means alonger review-often months longer-and delayed approval.

Buehler says that the new guidance will help reduce those discussions."Our intention in putting out this guidance is to provide morepredictability to the generic industry as to how they should preparetheir applications," he says.

The draft guidance helps manufacturers understand which degradationproducts they should list in their ANDAs, how to set acceptancecriteria, and what thresholds and procedures to apply when qualifyingdegradation products. The new guidance applies to generic drugs theguidelines established in the International Conference onHarmonization's November 2003 guidance, Q3B(R) Impurities in DrugProducts. "We want to make sure the policy for generic drugs is thesame as [the policy for] innovator drugs," says Lawrence Yu, directorfor science at OGD.

Buehler says the guidance will also help ensure consistency among the11 teams in OGD. "Because we hadn't clearly spelled out our policieswith respect to impurities, we had difficulty sometimes with theinterpretation of [those impurities] from division to division," heexplains. "This gives [manufacturers] a clearer idea of what we wouldexpect and also gives our own reviewers a clearer idea of what theoffice expects with respect to evaluating applications."

In some areas, the new guidance sets stricter standards for genericmanufacturers, because some Q3B(R) thresholds are lower than thestandards set in United States Pharmacopeia monographs,particularlyfor unspecified and unknown impurities. Nonetheless, Buehler and Yudon't expect a lot of industry comments on the draft. "The Office ofGeneric Drugs has been communicating with stakeholders and industry, soI think the industry will understand the approach and welcome a clearpolicy for impurities in generic drugs," says Yu.

Link to the guidance

–Laura Bush