FDA Goals for 2018: Speed Up Generic Drug Approvals, Enhance Competition

As part of their Drug Competition Action Plan, officials with the FDA have 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 development and review of generic drugs, the FDA has released 2 new documents aimed at streamlining and improving aspects of the submission and reviewing generic drug applications.

According to the statement, it currently takes the agency 4 review cycles on average for a new drug to reach approval, sometimes because the application is missing information needed to demonstrate that it meets approval standards. The new guidance will provide developers with key information about what is needed to avoid delays in the review process.

“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,” Dr. Gottlieb said in the statement.¹

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 ANDA 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 to work more efficiently in improving review times, according to the statement.

According to the FDA’s Activities Report of the Generic Drugs Program, the number of generic drugs approved by the agency has soared in recent months, with 87 approved in October 2017 and 84 approved in November 2017.² For the full 2017 year, the FDA approved a record number with 763 approvals.³

“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,” Dr. 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.”¹

In recent months, the FDA has enhanced several policies to improve generic development, including a published guidance on generic abuse-deterrent opioid development and a policy aimed at expediting the review of generic drug applications for certain products.

References

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 [FDA statement]. FDA’s website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm591184.htm. Accessed January 3, 2018.

2. Activities Report of the Generic Drug Program (FY 2017). FDA’s website. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm584749.htm. Accessed January 3, 2018.

3. Activities Report of the Generic Drug Program (FY 2018). FDA’s website. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm375079.htm. Accessed January 3, 2018.