As part of continuing efforts to increase access to generic medications, the FDA took several steps over the past year to promote competition in the market and reduce costs for patients. In 2017, the FDA reached new milestones with its highest number of generic drug approvals in a single month and a historic number of annual approvals, signaling promise for 2018.

Initiatives in the past year that focused on enhancing generic drug policies included published guidance on generic abuse-deterrent opioid development and a policy aimed at expediting the review of generic drug applications for certain products. Moving into 2018, the FDA is continuing to work toward speedier generic drug development and approvals. As part of its Drug Competition Action Plan, the agency has announced additional steps to encourage competition in the generic drug market, according to a statement from FDA Commissioner Scott Gottlieb, MD.1

To help speed up the development and review of generic drugs, the FDA released 2 new documents in January 2018 aimed at streamlining and improving aspects of the submission and review process for generic drug applications. It takes the FDA 4 review cycles on average to approve a new drug, sometimes because the application is missing information needed to demonstrate that it meets approval standards, according to the statement. The new guidance will provide developers with key information about what is needed to avoid delays.

“Through today’s guidance, as well as others from the agency, we can achieve one of the FDA’s key goals in 2018, to reduce the number of review cycles, by helping applicants avoid these common deficiencies that lead to review delays and application cycling,” Gottlieb said in the statement.

In one of the published documents, the FDA is formalizing a more streamlined review process, including new templates to make each cycle more efficient. The document establishes practices designed to help guide applicants. For example, if the FDA determines that an Abbreviated New Drug Application cannot be approved in its current form, reviewers must provide more detail to applicants to explain why and outline how this information can be provided.

The goal of this is to guide the FDA’s staff members to work more efficiently in improving review times, according to the statement. “The policies we’ve announced today and those that we’re anticipating in early 2018 represent our ongoing work on the Drug Competition Action Plan, one of the FDA’s highest priorities in 2018,” Gottlieb said in the statement. “In the coming year, we’ll be taking additional steps to improve our own practices and to help guide industry to make sure their generic drug applications can be acted upon as efficiently as possible.”

The number of generic drugs approved by the agency has soared in recent months, with 87 approved in October 2017 compared with 54 approved a year earlier, according to the FDA’s Activities Report of the Generic Drug Program.2,3 For full-year 2017, the FDA approved a record number, with 1027 approvals.4

Gottlieb touted the agency’s progress in a recent “FDA Voice” blog post and expressed similar goals for this year: “We believe that, if current trends continue, we’ll exceed this record number of generic drug approvals in 2018.”4

  1. Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to facilitate efficient generic drug review to enhance competition, promote access and lower drug prices [news release]. January 3, 2018. PressAnnouncements/ucm591184.htm. Accessed January 3, 2018.
  2. Activities report of the Generic Drug Program (FY 2017). FDA. ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm584749. htm. Updated November 13, 2017. Accessed January 3, 2018.
  3. Activities report of the Generic Drug Program (FY 2018) monthly performance. FDA. ucm375079.htm. Updated January 3, 2018. Accessed February 1, 2018.
  4. Gottlieb S. Reflections on a landmark year for medical product innovation and public health advances and looking ahead to policy in 2018. FDA Voice. ical-product-innovation-and-public-health-advances-and-looking-ahead-to-policy- in-2018/. Published January 9, 2018. Accessed January 30, 2018.