In a January 3, 2018, statement from FDA Commissioner Scott Gottlieb, MD, the FDA announced new steps to promote generic drug competition as a way to expand potential access to inexpensive medicines, which would be especially helpful for patients with cancer. These new steps are a part of the FDA’s ongoing implementation of the Drug Competition Action Plan.
The plan includes 3 main components for encouraging the development of generic drugs:
- Reducing gaming by branded companies that can delay generic drug entry
- Resolving scientific and regulatory obstacles that can make it difficult to win approval of generic versions of certain complex drugs
- Improving the efficiency and predictability of the FDA’s generic drug review process to reduce the time it takes to get a new generic agent approved and lessen the number of review cycles for generic drug applications before they can be approved.
The agency released 2 documents to streamline and improve the submission and review of generic drug applications, known as Abbreviated New Drug Applications (ANDAs): Good ANDA Submission Practices and Good ANDA Assessment Practices.
“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. 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,” Dr Gottlieb said.1
This draft guidance highlights common and recurring deficiencies the FDA sees in generic drug applications that could result in approval delays. One key reason why generic drug approvals are delayed is that many applicants require multiple review cycles. Dr Gottlieb pointed out that it currently takes an average of 4 cycles for an ANDA to reach approval, which is not necessarily because the drug will not meet FDA standards, but also because the application is missing information necessary to demonstrate that it does.
“These multiple cycles of review are costly and inefficient,” Dr Gottlieb explained. “They require a great deal of additional, avoidable work by both agency staff and the applicant and can delay the entry of generic competition.”1
While the pharmaceutical industry does its part to improve the quality and completeness of its drug applications, the FDA is also taking action to enhance the efficiency of its review process. The agency published a companion to the guidance that outlines ANDA assessment practices for the FDA’s staff and formalizes a more streamlined generic drug review process, including the introduction of new templates that will make each cycle of the review process more efficient and complete.
This companion document offers more detail, when available, on additional information that the generic drug applicant needs to provide to the FDA to support an approval decision during the next application cycle. This Manual of Policies and Procedures establishes these practices across offices charged with ANDA review, including the Office of Generic Drugs and the Office of Pharmaceutical Quality.
“The goal is to make sure that generic drug makers are made fully aware of the problems that are delaying the approval of their application and understand how to fix them,” Dr Gottlieb stated. It also clarifies the roles and responsibilities of different review disciplines to reduce inconsistencies and prevent duplicative and unnecessary work.
The FDA anticipates that these steps will significantly increase the efficiency and effectiveness of its generic drug review teams. Most important, “collectively, these changes are expected to expand access to generic medicines,” as the new manual indicates.
A Public Mission
“It’s part of our public health mission to ensure safe, effective, quality medicines are available to the patients that need them,” Dr Gottlieb emphasized. “Most importantly, the FDA will continue to be the gold standard for approval of all drug applications, and we will make sure that consumers can continue to trust in that assessment.”1
Dr Gottlieb noted that in 2017, the FDA approved a record number of generic medicines that included high-priority drugs and first-in-class generics, while also reducing the review cycles, all with the goal of expanding access to vital medicines.
- US Food and Drug Administration. 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. January 3, 2018. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm591184.htm. Accessed February 15, 2018.