Throughout 2017, the FDA focused its attention on the regulation of generic drug products. In 2015, the Agency issued only two generic-related guidance documents. In 2016, there were seven. In 2017, there were 15 guidance documents (including final, draft, and revised guidance documents) issued regarding ANDAs and/or generic drug products. Even more noteworthy is the fact that 11 of these 15 documents were issued after October 1st. Furthermore, the FDA published it’s first generic-related guidance document of 2018 in the first week of the year.
What is the story behind the FDA’s recent focus on generic products? Why has there been so much activity surrounding generics lately? There are a few likely reasons for this, and here’s what we think they are:
On August 18, 2017, the FDA Reauthorization Act (FDARA) was signed into law, officially reauthorizing GDUFA through September 30, 2022. The reauthorization, known as GDUFA II, took effect on October 1, 2017, and is intended to supplement congressional funding for the Agency’s review of generic drug applications.
There were three key changes introduced with the reauthorization of GDUFA, which are a large reason for the abundance of generic-related final and draft guidance documents that have been published since GDUFA II took effect. These changes include:
A majority of the fees are the same in both GDUFA I and II; however, it is important to note a few major differences, which include:
Under GDUFA II, ANDA submissions and amendments, as well as PAS submissions and amendments are categorized as either standard or priority. The reauthorization brakes down the different submissions into more refined categories, allowing the Agency to set appropriate review times for each subset of submissions depending on what it is, how important it is for public health, and how lengthy the submission is.
GDUFA II also provides detailed overview of the timeframes in which the FDA will review these submissions, which have been shortened in an attempt to improve patient access to generic products. This is important, as it will help hold the Agency more accountable, and it will help to eliminate the FDA’s backlog of ANDAs and prevent such a backlog from occurring in the future.
The Pre-ANDA program was created to clarify regulatory expectations for potential applicants early in the development process. For complex generic products, sponsors can now request a Pre-ANDA meeting. During this meeting, the sponsor will meet with the Agency to discuss and review its product’s development and receive advice from the FDA regarding ANDA development programs. Meetings can be held prior to submission of the ANDA to discuss the content and format of the application, or mid-review to discuss any deficiencies, concerns, or next steps that have been identified by the Agency.
In addition to the Pre-ANDA program, an ANDA review program was also established. This program was developed with the goal of expanding the frequency and scope of reviewer-sponsor communication. Under this program, FDA will allow sponsors to have an opportunity to correct deficiencies by communicating any issues in the middle of the review process rather than at the end in the Complete Response Letter (CRL).
Although there were only three major changes implemented within GDUFA II, there are a lot that goes along with each of these changes. As such, a great number of 2017’s guidance documents, specifically those issued after October 1st, are a direct result of the reauthorization of GDUFA.
It is widely known that the FDA has had a backlog of ANDA submissions for quite some time now. The size of the backlog has varied over time, reaching nearly 2,900 pending applications at the height of the issue back in 2012. Since then, the Agency has taken extreme measures to reduce the overflowing queue of pending applications. Although these efforts have been successful, there are still more applications awaiting review than the Agency would like to have on its desk at any given time. As such, reducing, and ultimately eliminating, this backlog is still a primary goal of the FDA. With this still on the Agency’s to do list, it is to be expected that there would be some extra attention being paid to generic drugs, resulting in an above average amount of relevant guidance documents being released.
Last but certainly not least, the final cause of the increased generic regulation is the FDA’s recent acknowledgement that there is an issue concerning drug competition and patient access to certain drugs.
High Drug Prices are Limiting Patient Access
In a blog post published by the FDA Voice on June 21, 2017, FDA commissioner Scott Gottlieb, MD stated that “too many patients are being priced out of the medicines they need.” Furthermore, he went on to note that, although the Agency is not directly involved in drug pricing, it can address the issue by “facilitating increased competition in the market for prescription drugs through the approval of lower-cost, generic medicines.” He noted that, “innovation in pharmaceutical development is essential because it creates new and sometimes life-saving therapies. But access to lower-cost alternatives, once patent and exclusivity periods lapse, also is critical to the nation’s health.”
In his blog post, Dr. Gottlieb stated that there are a number of scientific and regulatory obstacles inhibiting generic competition. As such, these barriers are delaying and, in some cases, denying patient access to more affordable drugs. This is an issue that requires immediate attention.
On June 27, 2017, a press release was issued from the FDA, announcing a number of steps the Agency is taking under its new Drug Competition Action Plan to “increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives.”
The Drug Competition Action Plan is just one part of the FDA’s solution to this problem. In addition, the FDA is also taking the following actions to solve the issue at hand:
As the Agency works to improve patient access to generic drugs and provide patients with more cost-effective options, the amount of information being released has increased. In the form of both draft and final guidance documents, as well as the proposal of new legislation and FDA rules, and so much more, the Agency’s dedication to facilitating competition in the market is the one of the main reasons behind the increase in generic-related activity in 2017.
It is clear that there a number of factors causing the significant spike in generic-related activity that occurred in 2017. However, we have yet to talk about the actual topics being addressed. As such, the following list includes the topic of each guidance document that was issued last year:
In addition, there has also been one generic-related guidance document published so far this year. On January 3, 2018, the FDA published a draft guidance entitled “Good ANDA Submission Practices,” and if 2017 was any indication of what is to come, it is likely just the first of many more to come throughout the year.
Are you in the process of developing a generic drug product? Do you need help preparing and submitting your ANDA to the FDA? We can help. Contact us today to learn more about our services and how we can help you obtain approval from the Agency.
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