Issues

User Fees

GPhA Position

The generic industry has stated its willingness to work with the FDA to create an effective and meaningful user fee program to provide more resources and more certainty in getting affordable generics to consumers. To make the user fee program work, FDA must address core fundamental issues that are blocking timely access to generic medicines. These core issues have been around for more than a decade – the citizen petition process, scientific consults, enhanced communication, more inspection resources, and the accountability and structure of the Office of Generic Drugs.

Key Points

To bring safe, effective and affordable generics to consumers faster, FDA must deal with core fundamental issues that have existed for more than a decade, including the citizen petition process, scientific, regulatory and legal consults, enhanced communication and accountability.

For example, in 2007, the brand industry held 2200 meetings with the FDA. Yet, the generic industry had only seven meetings during this year.. If FDA and the generic industry do not communicate more effectively, safe and affordable medicines simply won’t get to consumers faster.
Generic applications that are subject to scientific, regulatory or legal consults can languish for months, if not years outside the Office of Generic Drugs, resulting in protracted generic product reviews.

There is no doubt that FDA needs more resources to review and approve generic medicines. Yet, increased resources alone will not fix the underlying problem of timely consumer access. Simply put, there must be certainty in the review process.

During its negotiations with the brand industry, FDA granted the brand companies specific performance goals in exchange for an investment of resources. The generic industry should receive similar assurances. A significant investment in the generic approval process must ensure that the investment produces a meaningful program with measurable results.