The FDA is taking new steps to promote generic drug competition as part of its ongoing implementation of the Drug Competition Action Plan, according to a statement released by FDA Commissioner Scott Gottlieb, MD, on January 3, 2018. The Drug Competition Action Plan comprises 3 main components for encouraging the development of generic drugs: reducing the gaming that branded companies use to delay the entry of generic drugs to the marketplace; resolving scientific and regulatory hurdles that make it challenging for generic versions of certain complex drugs to receive approval; and improving the efficiency of the FDA’s review process to reduce the time it takes for new generic drugs to get approved.
According to Dr Gottlieb, the new steps being taken will specifically help the FDA achieve the plan’s third goal. These steps to streamline and improve aspects of the submission and review of generic drug applications, known as Abbreviated New Drug Applications (ANDAs), include 2 new documents released by the agency—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,” said Dr Gottlieb.
Good ANDA Submission Practices
This draft guidance for industry highlights common, recurring deficiencies the agency sees in ANDAs that could hold up their approval. Of note, 1 key reason behind delays for generic approvals is that many applications require multiple review cycles. Dr Gottlieb pointed out that it currently takes an average of 4 cycles before an ANDA is approved, citing that it is not necessarily because the drug will not meet FDA standards, but because the application is at times missing information that demonstrates the drug’s compliance with those standards.
These multiple review cycles are expensive and inefficient, and require additional work by FDA staff as well as the applicant.
Good ANDA Assessment Practices
While the industry does its part to improve the quality and completeness of applications, the FDA is taking action to enhance the efficiency of its review process. The agency published a companion to the Good ANDA Assessment Practices guidance, the Manual of Policies and Procedures (MAPP). This manual outlines ANDA assessment practices for FDA staff, and reinforces a streamlined generic review process that includes new templates that will make each review cycle more efficient and complete.
For example, the new MAPP asserts that when the FDA determines that an ANDA cannot be approved in its current form, reviewers should explain the deficiencies of the application to the applicant. This manual also outlines how this information should be provided, and, when available, provides more information about what the generic applicant needs to deliver to support an approval decision during the next application cycle.
The MAPP addresses all offices charged with ANDA review, including the Office of Generic Drugs and the Office of Pharmaceutical Quality. The goal of the MAPP is to ensure that manufacturers of generic drugs understand the issues delaying approval of their application, as well as how to correct them. It also aims to reduce inconsistencies and unnecessary work by clarifying the roles and responsibilities of different review disciplines. The FDA anticipates that these steps will significantly increase the effectiveness of its generic drug review teams.
Dr Gottlieb noted that the new MAPP does not modify the review goals or program enhancements of the Generic Drug User Fee Amendments II, and does not alter the regulatory requirements for ANDA approval.
“It’s part of our public health mission to ensure safe, effective, quality medicines are available to the patients that need them. 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,” he said.