December 5, 2017
New FDA guidance will make it easier for generic companies to get drug-device combination products approved.
The final guidance will explain the issues generic applicants should consider when design differences between a generic version of a branded drug-device combination product could impact 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, Washington, who previously held supervisory positions with the FDA, told Bloomberg Law Dec. 5.
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an FDA press officer, told Bloomberg Law in a Nov. 29 email the agency is reviewing the comments it received on the draft guidance and it will publish the final guidance as soon as possible.
Overall, the draft guidance “does a good job of clarifying the approval pathway for generic drug-device combination products. However, we hope that the final guidance improves on the draft in certain respects,” Bradley Merrill Thompson, general counsel for the combination Products Coalition, an industry group, told Bloomberg Law in a Dec. 5 email.
For example, Thompson said, the FDA should promote a tiered approach based on a risk assessment to determine the impact of the differences between a proposed generic product and the branded product rather than the binary approach described in the draft guidance. The risk assessment could describe the differences as catastrophic, critical, serious, minor, or negligible, he said. The binary approach in the draft describes the differences only as impact or no impact. Thompson also is a Washington-based attorney with Epstein Becker & Green PC and a Bloomberg BNA advisory board member.
Gottlieb said 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. Usually, the labeling for a branded product and a generic product have to be the same.
Thompson said his coalition agrees that this is an important point and thinks “the final guidance should foster a more holistic, risk-based approach with respect to labeling changes, and overall design differences.”
“We understand the reason for FDA’s emphasis on minimizing differences between a generic and reference product; however, this emphasis should not get in the way of innovation and improvements to the design of products and the applicant’s labeling of same,” Thompson said.
But Rosen told Bloomberg Law 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.”
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The draft guidance is at http://src.bna.com/uFl.
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