- Speech by
Janet Woodcock, M.D.
It is a pleasure to join you for this year’s AAM conference, and I look forward to being together in person soon.
We’ve made important strides in our efforts to combat COVID-19, although we still have a way to go.
I’m extremely proud of the work that the FDA has done in response to the pandemic, and I’m also very grateful for the continuing efforts of AAM and the many individual companies in the U.S. generics and biosimilars industry who have worked to find solutions to the continuing public health challenges.
As we begin to transition to the next stage of our recovery, and a gradual return to normalcy, it is important that we continue to maintain responsible behaviors that keep us safe, and work to ensure that everyone gets vaccinated and has access to vaccines and other products to respond to COVID.
The Importance of Access
Let me just repeat those last words – “has access to…” They underscore a key principle of any strong public health program-- one captured by the very name of this conference – Access 2021. Increasing access is not just a focus of AAM’s work, but also a centerpiece of the FDA’s mission.
Many Americans understand that the FDA’s responsibilities for protecting the public health include review of medical drugs and devices for safety and effectiveness. But they may be less aware that we strive to make those products as accessible to as many people and patients as possible through our efforts in regulatory science and help with development.
That’s part of the reason we conduct, support, and encourage scientific research to promote innovation that will lead to the development of new and groundbreaking treatments.
It’s why we develop and implement efficient, predictable, and transparent policies that will help speed drug development.
And it’s why we balance this work with a focus on increasing competition, especially generic versions of drugs that can be more affordable.
Indeed, affordability is an important part of accessibility.
Thanks to advances in medical science and hard work by the pharmaceutical industry we’ve witnessed the development of an extraordinary array of treatments in recent years. Not too long ago, some of these might even have been called medical miracles.
Quite simply, a groundbreaking treatment doesn’t mean as much for the patient who can’t afford or access it. That’s why generics are so important.
Today, patients in this country fill nine out of 10 prescriptions with generic drugs. One reason that number is so high is because so many of these prescriptions involve critically needed drugs.
But the impact on health is just one benefit. 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.
Moreover, because medical science is continually developing new products, there is a constant opportunity to produce new generics. At the FDA, we’re working to support and speed this development.
As you know, a few years ago we introduced the Drug Competition Action Plan (or DCAP), designed to facilitate generic competition and access across all our regulatory work, add flexibility, and expand our regulatory toolbox.
The goal is to improve the efficiency of the generic drug development, assessment, and approval process by reducing barriers for generics to enter the marketplace. These actions include streamlining the application process to reduce the cycles of application review – all without sacrificing clinical and scientific rigor.
We’ve made some important progress.
For example, we opened public dockets and issued guidance to seek user feedback on how we could enhance the Orange Book to make it as useful as possible for stakeholders.
We now update DCAP regularly with actions we’ve taken to improve the efficiency of generic drug development, assessment, and approval.
We’ve also worked to close some of the loopholes that allow some brand-name drug companies to “game” FDA rules in ways that delay the generic competition Congress intended.
And we are maximizing scientific and regulatory clarity with respect to complex generic drugs.
Sometimes, however, even the best laid plans are disrupted. That’s what happened when the SARS-COVID-19 virus arrived last year and enveloped the nation in a catastrophic public health emergency.
COVID-19 challenged everything we do: assessment, inspection, research, surveillance, and policy. Both new and long-standing issues were raised, including supply chains, changing demand, and decision-making based on evolving science and risk.
The good news is the FDA is built to respond to public emergencies. Our staff quickly applied its experience, preparedness, and expertise to the immediate public health demands of our nation, while continuing to meet our many regular and critical responsibilities.
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.
We 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.
And we prioritized the assessment of generic drug submissions involving potential treatments and supportive therapies for patients with COVID-19, even as we continued to approve regular generic drug applications.
The FDA has also maintained our focus on advancing complex drugs, providing guidance to manufacturers on how to more efficiently and effectively develop generic copies for any currently marketed, branded complex medicine.
This is important for the patients who need those treatments-- but also is valuable for developers, since complex generics can often help underwrite the costs of other generic applications, and thereby overcome some of the economic pressures that developers face.
We approved or tentatively approved hundreds of ANDAs, including many first generics. Despite the public health emergency, we did this at approximately the same level of recent years.
In addition, since the start of the pandemic, we’ve prioritized review of ANDAs that address the public health emergency. The FDA has already approved more than 900 original and supplemental ANDAs for these critical drugs.
To date, our Center for Drug Evaluation and Research (CDER) has, issued 49 enforcement regulatory discretion decisions to increase supplies of heparin, albuterol, etomidate, midazolam, propofol and many other essential medications. Where necessary, these decisions included additional manufacturing controls to mitigate the risk to drug quality.
I’ll turn now to biosimilars. I’m pleased to say interest in this sector continues to be vigorous. We are working to build an even more robust, competitive market, and strengthen the efficiency of biosimilar development. We are also working on new education initiatives to develop curriculum for use in medical, nursing, and pharmacy schools and to expand the availability of continuing education for health care providers.
As of May 1, 94 programs are enrolled in the Biosimilar Product Development (BPD) Program. We’ve approved 29 biosimilars, 20 of which are currently marketed. And CDER has received meeting requests to discuss the development of biosimilars for 43 different reference products. This is a significant bump compared to 12 approved and 4 marketed biosimilars when the Biosimilars Action Plan (BAP) was released in July 2018, and the future looks even brighter.
When we released the BAP, we described a number of actions the Agency was taking to help create a more competitive market and to encourage innovation. The BAP focused on four key objectives and outlined priority deliverables to help achieve those objectives. Since then, most of the key deliverables of the BAP have been completed and progress is actively being made on the remaining deliverables.
Some highlights include the release of the modernized Purple Book of Licensed Biological Products, which is now a dynamic, easy-to-use online search engine with timely information about all FDA-licensed biological products currently regulated by the FDA. Improving access to information about biological products options can lead to increased access to life-saving medications and lower health care costs.
We have continued to issue, revise, and finalize guidances on a range of foundational issues in biosimilar development and have also deployed application review templates specific for 351(k) BLAs to facilitate review and improve accessibility of information in the reviews when they become public.
We also continue work on important efforts such as education and outreach, collaboration and communication with international regulatory authorities, and the Federal Trade Commission.
In addition, CDER has been conducting research on the use of pharmacodynamic biomarkers to reduce the need for comparative clinical efficacy studies, helpful for increasing efficiency and providing more treatment options to patients sooner.
BsUFA and GDUFA Reauthorization
Our work to strengthen the biosimilar product development and review process gets important support from the Biosimilars User Fee Act.
As you know, BsUFA III negotiations are underway. We are working with industry on a number of key areas intended to strengthen the program, maximize scientific and regulatory clarity, and facilitate communication, predictability and efficiency in biosimilar and interchangeable product development.
While I’m on the topic of user fees, let me briefly mention the GDUFA reauthorization.
GDUFA provides essential support to our generic drug program, enabling us to bring greater predictability and timeliness to the assessment of generic drug applications and help accelerate innovation and competition.
For instance, the GDUFA program is strategically designed to make certain that generic medicines can be available to patients as soon as intellectual property protections – like patents or exclusivities – permit application approval.
GDUFA has also helped us strengthen and diversify the pipeline of generic drug applications, including complex generic drug products. In other words, our work to support the development of generic drugs begins long before the submission of applications.
And OGD’s GDUFA research programs support the investigation of generic development challenges and help us establish and clarify the scientific framework for ANDA development, submission, and assessments.
GDUFA I and II were each transformative for the generic drug program, and I’m confident that this latest iteration will be as well. We look forward to continuing to engage with industry representatives and other stakeholders as we move along in these reauthorization processes.
Building for the Future
The current pandemic challenged all of us, personally, as well as in our work. As we move into the next phase of our response, we have the opportunity to more closely examine what was successful and to prepare for future challenges.
Part of this will involve expanding our scientific and data capabilities through technology, data, and infrastructure modernization.
This will support every aspect of our work, from strengthening clinical trials, to conducting inspections, to preventing drug shortages.
In today’s global environment, with individual products sourced in many different countries, we often lack the necessary information, data, or visibility to ensure smooth production. Building new systems that provide better data and greater communication is one solution.
Another is to modernize production systems. Our Office of Pharmaceutical Quality’s Emerging Technologies Program offers enormous benefits to the generic drug industry in this area. It can address some of the underlying causes of drug shortages, improve manufacturing efficiency, and facilitate new complex generic products through the use of novel analytical tools.
We need to remain ahead of the technological curve to ensure that we can build on strong foundation we’ve established. Doing so will allow us to continue our work to do what is necessary to ensure that all patients who need essential medicines are able to gain access to them.
I look forward to working with you to achieve these goals.