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Remarks by Dr. Hahn to the “Advancing Innovative Science in Generic Drug Development” Workshop – 09/29/2020

Speech by
Stephen M. Hahn, M.D.

Leadership Role

Commissioner of Food and Drugs – Food and Drug Administration

It is a pleasure to join you for this important meeting today.  I’m sorry we can’t be together in person, but I am delighted to see such a full and diverse group registered for this virtual meeting.

I am extraordinarily impressed by the robustness of your agenda, which addresses some very exciting developments in generic drugs.

The work you are doing plays a vital role in our continuing efforts to support the development of affordable medicines.

Ensuring that patients who need safe and effective medicines and have greater access to them is a public health priority.  It is central to the work of the FDA, and it has also been a key element of my work throughout my career.

We know that competition from generic drugs can help lower drug prices and improve access for American patients and consumers.

These efforts are even more critical today as we are immersed in the consuming effort to find treatments and cures in response to the COVID-19 pandemic.

I am so proud of the dedication and expertise demonstrated by the FDA workforce during this crisis. 

They have tirelessly supported the development of safe and effective medical countermeasures to address the pandemic, and providing essential regulatory advice, guidance, and technical assistance that is needed to advance the development of tests, therapies, and vaccines.

What is more, even as they have been so thoroughly engaged on our COVID-19 response, our centers and offices have continued to fulfill the Agency’s regular mission-critical responsibilities, including our focus on ensuring access to lower cost, safe and effective, high quality generic medicines.

Even during this pandemic, we are currently on target to meet our user fee goals for drugs this year by reviewing and taking timely action on at least 90% of applications for brand-name and generic drugs.

The current pandemic has highlighted how important this aspect of our work is for Americans now, more than ever.

I’ve been heartened not only by the unprecedented level of collaboration across FDA but also by and with the generic drug industry in response to the pandemic.

During this public health emergency, the FDA has prioritized the assessment of generic drug submissions involving potential treatments and supportive therapies for patients with COVID-19.

We’ve been working with generic drug applicants whose development work has been affected by the COVID-19 pandemic.

And we’ve also worked diligently to support manufacturers of approved generic drug products who need to make changes to a manufacturing process or facility to address disruptions from the COVID-19 pandemic.

We’ve significantly expedited the assessment of these types of changes (known as supplements) to approved generic drug applications.

Since February, our generic drug program has worked with companies to approve over 500 of these ANDA changes, which have helped maintain the supply of medications for our most critically ill patients with COVID-19, including antibiotics, sedatives used in ventilated patients, anticoagulants, and pulmonary medicines. 

And I want to emphasize that throughout this crisis, we’ve maintained FDA’s commitment to the gold standard of evaluating drug product approvals based on safety and effectiveness.

Every one of the decisions we have reached – both related to COVID-19 and others – have been made by FDA scientists based on science and data.

Indeed, a focus on decisions based on data and science has always been the guiding principle of FDA’s work generally and of our generic drug program specifically.

Today’s workshop puts that principle into greater focus with its goal of helping pave a clear scientific pathway for generic drug development.

One important way we’re supporting that is through our Drug Competition Action Plan developed three years ago with a top priority of improving the efficiency of the development and assessment of generic drugs.

We’ve made enormous strides with this plan, which builds on the commitments and goals reflected in the Generic Drug User Fee Amendment agreement.

GDUFA is helping make the development of generic drugs easier and the review of generic drug applications more efficient by proactively addressing emerging scientific and regulatory challenges.

GDUFA I and II provided direct support for regulatory science, which allowed FDA to build a scientific and evidence-based foundation for the feasible and efficient development of generic drug products.

We are now beginning the process of reauthorizing what will be GDUFA III, and we look forward to working closely with the generic drug industry (as we did during the first two GDUFAs), with particular focus on reducing the number of review cycles to approval and increasing the number of approvals of safe, high-quality, and competitive generic drugs. 

One of the key features of GDUFA II is the pre-abbreviated new drug application (pre-ANDA) program, which was designed to support development of complex generic drug products.

This includes products with complex active ingredients, for example peptides, certain drug-device combination products such as auto injectors, and other products where complexity or uncertainty concerning the approval pathway or possible alternative approaches would benefit from early scientific engagement.

Complex generic drug products are, in general, harder to develop with traditional bioequivalence methods and fewer have secured FDA approval, resulting in less market competition for these drug products.

The GDUFA Science and Research Program enables FDA to address complex scientific issues for product-specific guidance development and to communicate with applicants through pre-ANDA meetings to help clarify regulatory expectations for prospective applicants early in the generic product development cycle. 

These early communications can help reduce a generic drug product’s time in the pipeline from concept to development to market by assisting generic drug applicants in developing more complete application submissions. 

To continue building on the program’s historic success, we must do our part to enable the same level of generic competition for complex products; products that were not foreseen in 1984 at the time of the Hatch-Waxman Amendments.

We need to keep pace with current science, and constantly improve our methodologies and approaches to establish bioequivalence.

Which brings us back the importance of today’s workshop, with its purpose of advancing innovative science in generic drug development.

For the last two years, this meeting has been known as the Complex Product Development workshop. 

This year we expanded its focus beyond just complex products to include complicated scientific issues that affect development of other products, such as oral products.  

During the workshop you will hear from FDA experts on topics ranging from modeling and simulation that could support alternative bioequivalence approaches to products with complex active ingredients, including peptide products, inhalation and nasal products.

You will also hear some timely updates and announcements from us on various topics, like the Inactive Ingredient Database.

Throughout the workshop, FDA staff will convey information about our most recent scientific advances and regulatory advice, which are an integral part of the solution to addressing complicated scientific issues in generic drug development.

This workshop, and your involvement in it, is a critical part of paving a clear pathway for industry that starts with advances in science leading to new understandings of methods for determining equivalence.  This, in turn, feeds into tangible generic drug product development and ANDA submissions, with an ultimate goal of approval of generic drug products.

This pathway work allows us, FDA and industry working together – to deliver affordable, high quality, safe, and effective generic products in a timely fashion and meet the needs of the American public.

I want to thank you for your participation today, and for everything you do to advance the development of accessible and affordable medicines.