FDA Plans Guidance to Speed Approvals of Generic Drug-Device Combos

New FDA guidance will make it easier for generic companies to get drug-device combination products approved.

The final guidance, which the FDA is working on, will explain the issues generic applicants should consider when design differences between a generic version of a branded drug-device combination product could affect the clinical effect or safety profile of the generic product, Food and Drug Administration Commissioner Scott Gottlieb said recently.

Gottlieb, who spoke Nov. 28 at the FDA’s Generic Drug Science Day, said as long as the generic applicant can demonstrate that the differences don’t affect the clinical effect or safety profile when the generic is substituted for the branded product, the generic can receive approval.

Drug-device combination products include Mylan Inc.'s allergy treatment EpiPen. Mylan came under attack for increasing the cost of EpiPen by 400 percent in nine years. The company was able to increase the price due to a lack of competing products, and the final guidance will make it easier for generic competition to come to market to help lower prices.

Gottlieb is trying to “take some initiative to foster the availability of generic drugs in this country” and address issues that have blocked generic entry, David Rosen, a partner and public policy lawyer with Foley & Lardner LLP in Washington, who previously held supervisory positions with the FDA, told me.

Among other things, the final guidance will allow a generic product to have certain labeling differences from the branded product if the labeling changes come from permitted design differences, Gottlieb said. Usually, the labeling for a branded product and a generic product have to be the same.

Rosen told me that allowing labeling differences could cause safety issues. For instance, the EpiPen has very specific instructions on how to use it. If differences in labeling are permitted, a company making a generic product that’s interchangeable with the EpiPen could have slightly different directions for use.

“We have to make sure that there’s no potential for patient confusion, as well as caregiver confusion” if there are differences in the labeling, Rosen said. “What we don’t want, is something that is less safe or less effective than what is currently out there.”

The draft version of the guidance was issued in January. It is unclear when the final guidance will be issued.

Sandy Walsh, an FDA press officer, told me the agency is reviewing the comments it received on the draft guidance and it will publish the final guidance as soon as possible.

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