Dr. Hahn's Remarks to the GRx+Biosims 2020 Virtual Conference November 9, 2020

Speech | Virtual

• Speech by: Stephen M. Hahn, M.D. ; Commissioner of Food and Drugs - Food and Drug Administration ( December 2019 - January 2021 )

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It is a pleasure to be with you for this year’s GRx and Biosims meeting.  I’m sorry we can’t be together in person.

We’ve been immersed in the public health emergency triggered by the SARS-CoV-2 virus for more than eight months now.   

During that time, we have become more aware of its dangers, altering our behaviors, and advancing in our scientific and medical research.

But our work is nowhere near done.  We need to continue our collaborative efforts to contain the spread and to find new treatments and vaccines.  

I want to thank the AAM for your response to this public health emergency.  I know that many companies in the U.S. generics and biosimilars industry have played an important role as partners in these efforts.  And we appreciate your Blueprint outlining incentives for ways to diversify the supply chain and enhance manufacturing of pharmaceuticals in the US.  These are essential aspects of the collaboration necessary to defeat this virus.

At the FDA we’ve also been working non-stop.  Our 17,000+ employees have demonstrated extraordinary diligence, knowledge, and commitment, literally working around-the-clock to find answers to some of the most challenging public health questions we’ve faced in over a century.

Even as we have been working full steam on the response to COVID-19, our centers and offices have continued to fulfill the Agency’s regular mission-critical responsibilities, including our essential role to help ensure access to safe and effective, high-quality generic medicines.

We take this responsibility very seriously, especially during a time of crisis.

We have prioritized the assessment of generic drug submissions involving potential treatments and supportive therapies for patients with COVID-19.  We’ve done this while evaluating products based on quality data and sound science and maintaining the FDA’s gold standard for drug approvals.

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

We’ve supported manufacturers of approved generic drug products who need to change a manufacturing process or facility to address resulting disruptions, such as quarantines, infection outbreaks among employees, site closures, travel limitations, as well as supported applicants who have experienced interruptions to the supply chain for the proposed generic product or the reference-listed drug product.

And our Office of Generic Drugs has continued to work at full capacity to complete our regular responsibilities to help ensure that safe and effective, high-quality generic drugs are available to the public.

In FY 2020, FDA approved or tentatively approved more than 900 generic drugs, including 74 first generics. In addition, we approved more than 30 original ANDAs including many drugs with increased demand related to this public health emergency, as well as products used to treat secondary conditions associated with COVID-19, such as albuterol sulfate inhalation aerosol, azithromycin and heparin sodium.

We’ve also maintained our pace of recent years to meet our goals on reviewing applications for medical products during the pandemic. 

For instance, in FY20 we met most of our user fee goals for drugs by reviewing and taking timely action on at least 90% of brand, generic, and biosimilar drug applications even during the pandemic.  Congressionally-authorized user fees provide resources to enhance the efficiency of the review process, and we take our responsibility to fulfill these commitments very seriously.

One point I want to mention, because I know there has been particular interest among your membership, is possible changes to the 30-month window for obtaining tentative approval.

As you are aware, in certain situations, Congress has extended or modified the 30-month forfeiture period.  We can’t speculate on whether Congress will make such changes to the existing statutory 30-month timeframe due to the COVID-19 pandemic.

If an ANDA fails to obtain tentative approval within the statutory timeframe, we consider whether this failure was caused by a change in or a review of the requirements for approval imposed after the application was filed.  If so, the application may qualify for an exception to the forfeiture provision.

The agency continues to act on all generic drug program application assessment activities that can be conducted remotely in as timely a manner as possible, including taking action before the 30-month forfeiture date.  We’ve also recently restarted pre-approval inspections in a limited capacity and continue to use other tools and approaches to avoid delays as much as possible.

As you know, in March, the FDA postponed on-site domestic and foreign routine surveillance inspections due to concerns around the pandemic, although FDA investigators have continued to conduct mission-critical inspections both domestically and abroad, along with other activities to ensure FDA-regulated industries are meeting applicable FDA requirements.

In July, we resumed prioritized domestic surveillance inspections, and we are using all available tools and sources of information to support regulatory decisions on applications that include sites impacted by FDA’s ability to inspect due to COVID-19.

The FDA is also expanding the use of other tools and approaches that have proven effective to help ensure the quality of drug products imported into the United States during this interim period, when possible.

These may include physical examinations of products arriving at U.S. borders or product sampling and testing before release into commerce, reviewing the compliance histories of facilities, using information shared by trusted foreign regulatory partners through mutual recognition and confidentiality agreements, and requesting records directly from facilities “in advance of or in lieu of” certain drug inspections.

CDER and CBER are continuing to evaluate applications, strategically applying a holistic approach in the decision-making process to determine if an inspection is warranted or if an inspection is no longer needed due to information gained through the use of the additional tools mentioned above.

The FDA also has the ability through its Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (or PREDICT) import screening tool to focus its examinations and sample collections based on heightened concerns of specific products being entered into U.S. commerce. The PREDICT screening has continued to adjust product risk scores as necessary throughout the COVID-19 outbreak.

As this brief discussion of inspections indicates, in this area and many others, we are adapting to the current challenges and applying we have learned to carry out our responsibilities.

This is a unique strength of the FDA – to be prepared to respond through planning and designated resources and to apply what we have learned previously, rather than simply be reactive.

Our experience includes strategies developed in response to urgent public health needs as wide-ranging as the Ebola Virus, outbreaks from foodborne illnesses, and dangerously tainted medical products.  And our response is informed by our research, investigation and enforcement mechanisms, strengthening our rulemaking apparatus, and by the application of hard science and rigorous data.

One way we’ve sought to support these efforts is with the launch of the COVID-19 Pandemic Recovery and Preparedness Plan (or PREPP), which focuses on identifying avenues for improvement by coordinating scientific leadership, agency operations, communications, and programming across the agency for all regulated products. 

Examples of this can be seen across the FDA’s operations. I’ll briefly mention just a few.

For example, we’ve developed new means of coordination to help move new treatments to patients as quickly as possible.  Our Centers for Drug Evaluation and Research (CDER) and our Center for Biologics Evaluation and Research (CBER) initiated the Coronavirus Treatment Acceleration Program (CTAP), a special emergency program that accomplishes this goal while at the same time working to ensure that treatments are helpful, not harmful.  
 
When CTAP was initially launched, 72 clinical trials of potential therapies for COVID-19 were underway with FDA oversight. As of September 30, 2020, more than 550 drug development programs are in planning stages, more than 350 clinical trials have been reviewed to determine that an Investigational New Drug application (IND) is safe to proceed, and five COVID-19 treatments received authorization for emergency use.

We’ve streamlined many of our processes to make it easier for developers and scientists to send inquiries and requests. 

To date, the FDA has issued more than 60 related guidance documents and has revised COVID-19 related guidance documents to provide updated policies , transparency, and regulatory flexibility to address the vital medical products and public health issues facing the American public during this pandemic.  These guidance documents provide clarity on a wide variety of topics, from diagnostics to the conduct of clinical trials. 

We’ve accelerated the need for investing in advanced manufacturing to increase access to critical medical products, including generics and biosimilars.

We’ve taken a fresh look at how clinical trials can be designed and conducted. 

And we’re also looking at additional data sources to aid our evaluation of medical products.  For example, the availability of digital health data holds promise to inform product development for COVID-19. 

Clinical data collected outside of traditional clinical trials — or “real-world data” (RWD) — can help accelerate FDA’s understanding of how COVID-19 is affecting patients and help FDA advise product developers on how to optimize the design of clinical trials.

Evaluation of real-world data also has the potential to provide a wealth of rapid, actionable information to enable us to better understand disease symptoms, describe and measure immunity, and use available medical product supplies to help mitigate potential shortages.

These are just a few of the ways we are working to ensure that we continue to fulfill our critical public health responsibilities and maintain our high standards during the pandemic. 

But we also want to continue to apply this energy, resourcefulness, and innovation to further increase accessibility to medications for the benefits of patients and consumers. 

Thanks to the hard work and collaboration of industry and the FDA, we have built a modern generic drug assessment program, with a very strong pipeline of generic drug applications and a robust development pathway.  We are committed to ensuring continued accessibility of these medical products.

In closing, I want to underscore one other point, and that is that all of our work – whether in response to this pandemic or in fulfilling our regular responsibilities – is based on the application of good science and rigorous data. 
That’s vital because it is essential that the American public have complete confidence in the products we regulate.  Speed in reviewing them is important, but so are safety, accuracy and effectiveness.

We look forward to working with you as we move forward in our search to find answers, develop strategies and solutions, and apply the lessons learned to future actions. 

Thank you.