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The New Reality of Generics under GDUFA

From recent news, we know that the FDA has been under increasing pressure to reduce the timing of its reviews while maintaining the highest possible standards for safety and efficacy of the products it approves. This is the reason for the PDUFA and now the GDUFA goals. (link) noted that the Agency received more ANDAs within the first two-thirds of 2017 (877 applications) than it did during all of 2016 (852 applications), which was significantly more than 2015.

While many drug manufacturers have applauded the efforts to reduce time to market for their products, they often don’t realize the trade-offs that come with that progress. The need to accelerate the review process has apparently reduced the Agency’s tolerance, or ability to tolerate, incomplete applications. For example, along with the increasing numbers of applications submitted, the FDA’s Office of Generic Drugs is now handing out an increasing number of Refuse to Receive (RTR) and Complete Response Letter (CRLs) decisions due to the submission of incomplete or flawed applications.

The Numbers Speak

FDANews notes that “for fiscal 2017, the agency has totaled 477 approvals so far, 119 of them tentatively, while issuing 1,124 complete response letters;” though, it is not clear if this refers to new and backlogged ANDAs only or if this also includes NDAs. Given the pressure among generics companies to be first to file, potentially providing a market advantage through brief market exclusivity, the game is changing to ensure that, in addition to being the first application submitted, the original ANDA submitted has to be complete enough to support FDA review and approval. This means that the days of getting the submission in early and filling in the details later are over.

New Opportunities

The Agency is also offering new opportunities for Sponsors to work with the Agency to define the path to approval for sponsors developing more complicated products. Obtaining and leveraging this feedback from the Agency is critical to defining the most efficient path (both time-wise and dollar-wise) to approval. While it appears the path to such meetings is still being worked out by the Agency, it is important to remember that the same approach that Premier Consulting applies to its 505(b)(2) products can also be applied to generic products. That is, it is always best to work with the Agency to present a scientifically credible yet aggressive approach to support approval, and to ensure that the proposed strategy is backed up with data. Premier Consulting has had success with this approach in the 505(b)(2) space and is working to create similar success in the generics space.

First-to-File Strategy and Differentiation

While getting the coveted 180-day Hatch-Waxman exclusivity is one strategy to gain significant market share for a generic, it is worth noting that the 505(b)(2) pathway provides alternate methods of improving market penetration through product differentiation.

Through relatively simple modifications of a product development program, a Sponsor could significantly differentiate its product from an innovator product. With the appropriately integrated development and marketing strategies, Sponsors can significantly improve their market share while minimizing the overall development program requirements.

Premier Consulting has a proven track record in developing products, both highly complex and less so, and knows how to work with the FDA to improve the chances that a sponsor will be successful both in gaining approval and in earning and protecting market share. For more on how Premier Consulting can support your development program, contact us.