FDA Announces Public Meeting on Generic Drugs

On June 21, 2017, FDA Commissioner Scott Gottlieb announced, in an FDA Voice blog post, a public meeting to be held July 18, 2017 to gain insight on standards and procedures regarding development, approval, and access to generic drugs. The meeting is part of the agency’s Drug Competition Action Plan to encourage competitive pricing in the pharmaceutical market.

Gottlieb stated that making lower-cost alternatives available to patients is important to the nation’s health, and the agency plans to review its rules and regulations regarding generic-drug approvals. The agency is aware that branded companies may be using regulatory strategies to try and block generic drug development, the commissioner stated.  “We know that sometimes our regulatory rules might be ‘gamed’ in ways that may delay generic-drug approvals beyond the time frame the law intended, in order to reduce competition. We are actively looking at ways our rules are being used and, in some cases, misused,” Gottlieb stated in the blog post. To combat some of these problems, FDA hopes the upcoming public hearing will shed light on some of these types of circumstances.

During the July meeting, the agency will also be looking for input on its Drug Competition Action Plan and how the agency’s policies may or may not be working to create a balance between innovation and patient access. Gottlieb hopes “to broaden access to safe and effective generic drugs that can improve access to medicines and help consumers lower their healthcare costs. As in all of the things we do, we will steadfastly maintain FDA’s gold standard for rigorous, science-based regulation.”