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Building on Successes of the Generic Drug Program, FDA Sets the Stage for the Next Generic Drug User Fee Amendments (GDUFA) Reauthorization Process

In this CDER Conversation, Sally Choe, director of the Center for Drug Evaluation and Research’s (CDER) Office of Generic Drugs and Mike Kopcha director of CDER’s Office of Pharmaceutical Quality discuss reauthorization of GDUFA.

Starting tomorrow, FDA begins the important process of considering public input, meeting with stakeholders, and engaging in negotiations with the generic drug industry as part of the process for Congress to reauthorize the Generic Drug User Fee Amendments (GDUFA) for another five years. Reauthorization of GDUFA will allow for critical funding of FDA’s generic drug program so the agency can continue to ensure Americans have access to safe, effective and high-quality generic drugs.

What is GDUFA, and how does the reauthorization process work?

Mike Kopcha
Mike Kopcha

KOPCHA: Congress enacted GDUFA in 2012. GDUFA ratified an agreement negotiated by the generic drug industry and the agency to provide industry user fees to FDA. These fees enable improved predictability and timeliness to the regulatory review of generic drug applications. FDA transformed the generic drug program in the first GDUFA authorization (GDUFA I) by hiring more than 500 additional staff for the generic drug review program, including assessments and inspections. Importantly, GDUFA enabled FDA to approve more generic drugs more quickly than ever before, resulting in increased marketplace competition as well as improved access to medicines for patients.

Building on the success of GDUFA I, the first GDUFA reauthorization (GDUFA II) included increased focus on the development and review of “hard-to-genericize” complex products, reduced timeframes for approvals with increased communication and collaboration with industry, provided additional support to applicants preparing their generic drug applications, and streamlined business processes to increase “first cycle” approvals.  

CHOE: Congress must reauthorize GDUFA every five years, and the current GDUFA II authorization expires at the end of September 2022.  Although we are still two years away from the end of GDUFA II, we are gearing up for GDUFA’s third iteration now. We enter this reauthorization process building on the successes of GDUFA I and GDUFA II, which enabled the most robust generic drug review program to date.  The continued work by FDA and the generic drug industry through a GDUFA III program will ensure that Americans will have access to safe, high-quality, more affordable generic drugs.

How does GDUFA benefit public health?

Sally Choe
Sally Choe

CHOE: Access to affordable medicines is a significant public health priority, and competition from generic drugs can help lower drug prices and improve access for American patients and consumers. GDUFA user fees bring greater predictability and timeliness to our assessment of generic drug applications for approval, ultimately increasing access while maintaining our rigorous approval standards.

KOPCHA: GDUFA impacts more than just application assessment and doesn’t just focus on approvals to promote drug competition and patient access. Rather, the GDUFA program is strategically designed to support the development of generic drugs long before the submission of applications. This helps make certain that generic medicines can be available to patients as soon as intellectual property protections – like patents or exclusivities – permit application approval. In other words, we work years before receiving submissions to create the most efficient assessment process once applications come in the door.  

One reason we are able to do this is because our robust GDUFA Science and Research Program helps proactively ensure that the development, assessment, and manufacture of high-quality generic drugs is based on rigorous scientific standards that reflect cutting-edge science. The agency’s scientific experts conduct their own research, and we also provide grants to the leading scientists and researchers in the field, the results of which we make publicly available. Leveraging this work, we develop recommendations that support science-based methodologies for the development and evaluation of generic drugs. This type of work is particularly important for complex generic drug products, which are harder to “genericize” and often have less market competition.  

CHOE: An example of how we leverage science and research is through recommendations in general and in "product-specific” guidances to help applicants develop generic medicines that can meet our high standards for approval. Recommendations in product-specific guidances help make industry’s research and development decisions more efficient and cost-effective by identifying the most appropriate methodology and evidence needed to support a specific generic drug’s comparison with the brand name drug during FDA’s assessment process, which can streamline product approvals. As of June 2020, FDA has published more than 1,900 product-specific guidances for industry since it first began doing so in 2007.

Established under GDUFA II, the pre-Abbreviated New Drug Application (pre-ANDA) program provides product development assistance to generic developers through written communications and meetings with industry to help clarify regulatory expectations early in the generic product development process and during FDA application assessment. This program provides a special focus on complex generic drug products, such as some inhaled or injectable products, which are usually harder for generic drug developers to copy, often leading to a lack of generic competition even after patents and exclusivities no longer block generic approval.

This strategic, proactive approach to supporting generic drug development and assessment with GDUFA research funding has a real impact on American patients. GDUFA-funded research supported the generic drug industry through science-based recommendations for generic product development and directly facilitated the assessment and approval of a number of complex generic products in GDUFA II. For the first time, patients with asthma now have a generic albuterol sulfate inhalation aerosol (ProAir HFA) product, patients with chronic obstructive pulmonary disease now have a generic fluticasone propionate/salmeterol inhalation powder (Advair Diskus) product, and patients with herpes simplex virus now have a generic acyclovir cream (Zovirax) product.

How has GDUFA II set the stage for GDUFA III?

KOPCHA: With GDUFA I and II, FDA has demonstrated its leadership in helping to ensure that more safe, effective, high-quality generics are available to the patients who need them most. We have established a generic drug program that is strategic in its structure and activities, and communications with industry. With each authorization of GDUFA, the program continues to improve predictability and transparency, driving an efficient and effective application assessment process. As a result, the U.S. has a very strong pipeline of generic drug applications and a robust development pathway.

We directly support developers of complex generic drug products to ensure that patients and consumers have access to generics of the drugs they need, at prices they can better afford. Notably, GDUFA II coincided with the implementation of FDA’s Drug Competition Action Plan, which focuses on developing and delivering general policies to further the availability of generic medicines to the public.  We will never rest on past successes, and we know there are additional ways to strengthen the program. We look forward to GDUFA III as an opportunity to work with generic developers to strengthen the program in ways that will further enhance public health. 

What do you have planned for the GDUFA III process?

CHOE: Many people don’t know that the GDUFA reauthorization process involves not only the direct negotiation with representatives from the generic drug industry, but also important input from other stakeholders during an open process that starts on July 21, 2020 with FDA’s virtual public meeting.  At this meeting, FDA, industry, and other interested stakeholders will provide their views on the reauthorization of GDUFA for fiscal years 2023 through 2027. The agenda will include presentations by FDA staff and stakeholder groups, as well as time allotted for public comment and discussion. 

KOPCHA: Public input does not stop at the upcoming public meeting. FDA will hold regular stakeholder meetings with publicly posted meeting minutes over the course of negotiations. After negotiations with the generic drug industry, FDA will send the agreed-upon recommendations to Congress, and Congress will hold hearings that include testimony from FDA experts, the generic drug industry, and other interested parties. At each step, FDA looks forward to maximizing and building on the successes of GDUFA I and II to meet our deeply important public health commitment to assure safe and effective, high-quality generic drugs are available to patients. Don’t forget that we at the FDA are patients too. We rely on generic drugs for our health and the health of our families. 

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