FDA Promoting Generic Competition

[The following post has been excerpted from comments by FDA Commissioner Scott Gottlieb as published by the FDA on its website on January 03, 2018.]

The FDA has announced additional steps to encourage generic competition as part of our continued implementation of the Drug Competition Action Plan. This plan has three main components:

• 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; and
• improving the efficiency and predictability of the FDA’s generic review process to reduce the time it takes to get a new generic drug approved…

The new steps we’re announcing…go toward achievement of this third goal. We expect to take additional steps this year to promote competition; to help reduce drug prices and improve access to medicine for Americans.

Specifically, the FDA is releasing two documents…that together will streamline and improve aspects of the submission and review of generic drug applications (known as Abbreviated New Drug Applications, or ANDAs). The first is a draft guidance for industry – “Good ANDA Submission Practices” – which highlights common, recurring deficiencies we see in generic drug applications that may lead to a delay in their approval.

One key reason why generic approvals are delayed is that many applications need to undergo multiple cycles of review. While often this is because the application lacks sufficient scientific evidence to support approval, there are also many times when the FDA must ask applicants for additional information in order to determine that the requirements for approval have been met, even if an application meets the threshold requirements for filing. In fact, it currently takes on average about four cycles for an ANDA to reach approval…

These multiple cycles of review are costly and inefficient. They require a great deal of additional, avoidable work by both agency staff and the applicant and can delay the entry of generic competition. 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.

While industry does its part to improve the quality and completeness of applications, the FDA also is taking new steps to enhance the efficiency of our review process. Today, we’re publishing a companion to the guidance in the form of a Manual of Policies and Procedures (MAPP) – “Good ANDA Assessment Practices” – which outlines ANDA assessment practices for FDA staff. The document formalizes a more streamlined generic review process, including the introduction of new templates that will make each cycle of the review process more efficient and complete…

The FDA’s generic drug team already has made substantial investment in process improvements that are yielding faster assessment and approval times, translating to direct benefits for consumers through more approvals of lower-cost drug options. In 2017, we had several record-breaking months for the number of generic medicines approved in a single month, most recently in November, when we approved the highest number of generic medicines in the FDA’s history…

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. For example, we’ll be building on our initiatives to accelerate generic entry of complex generics, which include medicines like…costly injectable drugs, which are sometimes hard to copy.