Remarks by Dr. Woodcock at the FDA FY 2021 Generic Drug Science and Research Initiatives Public Workshop June 23, 2021

Speech | Virtual

• Speech by: Janet Woodcock, M.D.

(Remarks as prepared for delivery)

 
I am pleased to have this opportunity to address the 2021 Generic Drug Science and Research Initiatives Public Workshop.  I’m sorry we can’t be together in person, and I look forward to that day soon.

For well over a year now, the COVID-19 pandemic has dominated our personal and professional lives.

Across the FDA, I’ve seen the strength and resilience of FDA staff who quickly applied their experience, preparedness, and expertise to implement new systems and processes to respond to the COVID-19 public health emergency, while continuing to meet our many regular and critical responsibilities.

The generic drug program was no exception. For example:

• Our Office of Generic Drugs addressed the potential impact that the public health emergency may have on Abbreviated New Drug Application (ANDA) applicants’ bioequivalence studies, and the submission of ANDAs to FDA for assessment.

• Our Office of Pharmaceutical Quality worked with manufacturers of approved generics who needed to make changes to manufacturing processes of facilities that experienced disruptions from the pandemic.  

• And FDA prioritized the assessment of generic drug submissions involving potential treatments and supportive therapies for patients with COVID-19, even as we continued to assess other generic drug applications. FDA has already approved more than 900 original and supplemental ANDAs for these critical drugs.

All the while, FDA’s Science and Research Program, established under the Generic Drug User Fee Amendments, or GDUFA, has continued its important work.

Good science and rigorous research are the lodestar of the FDA.  And they are a critical piece of our work to support and modernize the generic drug program and the generic drug industry and help ensure the continued supply of safe and effective generic drugs to the American public.

We know the importance of generic drugs to the public.  Patients today in our country fill 90 percent of prescriptions with generics.  And many of these are critically needed, often life-saving drugs. 

Generics also mean enormous economic savings.  In the past decade, generic forms of drugs have saved more than $2.2 trillion dollars in public health costs. 

The Generic Drug User Fee Amendments, GDUFA I and GDUFA II, have provided direct and essential support for generic-related science and research at the FDA and helped ensure that we continue to improve the efficiency of the generic drug development, assessment, and approval process.

During previous authorizations and reauthorizations of this law, we have worked productively with industry to strengthen it.  We continue that tradition now, as we work toward the law’s latest iteration.  

GDUFA-funded research was intended to accelerate scientific and technical advances for generics, to modernize evidence-based bioequivalence standards, and to ensure that regulatory concepts are compatible with the innovations in drug development that have occurred across the last several decades.

Quite simply, the scientific research funded by GDUFA helps build an essential bridge from the scientific knowledge of the 20th Century to our work as an effective health and consumer protection agency for the 21st Century.

To do this, however, we need to continue expand our scientific and data capabilities.

That’s why, for instance, the FDA recently began an important effort to become even better informed, more efficient, and better prepared, by launching the Technology Modernization Action Plan (TMAP) and Data Modernization Action Plan (DMAP). 

It is essential that the FDA’s regulatory decision-making is based upon the most current scientific evidence, that bioequivalence standards are as efficient as possible, and that the approaches to develop generic drugs and to assess ANDAs incorporate 21st Century technologies.

Nowhere is this need more obvious than in the development of complex generic drug products. The generic drug science and research program has delivered new approaches in many categories of complex products and has allowed FDA to build a scientific and evidence-based foundation for the feasible and efficient development of these products.

Generics of complex brand name drugs or reference listed drugs can be more difficult to develop, such as those for peptide drug products, dry powder inhalers or topical medicines.

The historical difficulty to develop complex generics, compounded by the inefficiencies that have limited generic competition, mean that a complex drug product is less likely to have an available generic.

Insights gained from GDUFA-funded scientific research have enabled the agency to articulate viable and scientifically sound alternative approaches for industry to demonstrate bioequivalence for complex generics. 

Consider a few recent examples:

• In December 2020, the FDA approved the first complex generic of glucagon to treat severe hypoglycemia (very low blood sugar) in patients with diabetes. The brand name product was approved over 20 years ago, and this approval of a synthetic peptide generic product was finally made possible because of the FDA’s research on analytical methods for peptides and immunogenicity testing for peptides.

• In January 2021, the FDA approved the first complex generic for a parenteral (non-oral) iron product that treats iron deficiency anemia. The FDA’s scientific investment in characterization and advanced bioequivalence study designs was essential to this approval.

• And in February 2021, the FDA approved a complex generic for loteprednol etabonate ophthalmic (eye-related) suspension to treat eye inflammation using a new in vitro bioequivalence approach. Without the new approach, applicants would have had to recruit hundreds of cataract surgery patients to demonstrate bioequivalence. Investments in particle size characterization and eye models supported this more efficient bioequivalence method.   

As you hear about some of the research projects described in today’s workshop, I urge you to contemplate what it takes for them to be translated into tangible and practical answers that support generic drug development.

One important activity is early and productive communication between FDA staff and drug developers, including providing responses to controlled correspondence, issuing product-specific guidances, and conducting pre-ANDA meetings. 

These kind of interactions with prospective generic drug developers during product development help clarify regulatory expectations and help reduce industry’s uncertainty about adopting new bioequivalence approaches.

And our staff is able to efficiently carry out these essential activities in part because of the work done in the GDUFA science and research program.

During the ANDA assessment process, for example, FDA staff utilize the insights gained from GDUFA-funded scientific research to support regulatory decision making.

A central purpose of today’s workshop is to facilitate the critical collaboration between the FDA and generic industry stakeholders.  We can then appropriately prioritize specific scientific challenges and knowledge gaps that, when addressed by research, can support numerous activities that facilitate generic drug development. 

Both industry and the FDA benefit from the GDUFA science and research programs. Ultimately, however, it’s the American patient that profits most, since these activities contribute to timely approvals of critical and cost-saving generic drug products.

Continued robust investment in generic drug science and research will help modernize and maximize the use of the generic pathway to provide safe and effective generic drugs to the American Public.

GDUFA-funded scientific research allows FDA to adapt and optimize our approaches and regulatory decision making to ensure the availability of effective generic drug approval pathways , particularly for complex products. When drug developers use this pathway, patients are able to benefit from a proven system of high-quality and more affordable substitution of generics at the pharmacy.

Several presentations today focus on modernized approaches that use computational models, machine learning and other state-of-the-art simulations that minimize the need for testing of generic drug products in humans.

Numerous additional scientific challenges are on the horizon. But I’m confident that FDA’s generic drug program will rise to the challenge. Today’s workshop represents an important opportunity for engagement and collaboration, to identify and prioritize how and where we invest our resources to prepare for a thriving and sustainable generic drug program in the 21st Century.

Thank you again for your participation, and I hope you have a productive day.