- Speech by
Janet Woodcock, M.D.
I’m delighted to have this opportunity to speak to the members of the Regulatory Affairs Professionals Society (RAPS) and to help kick off what I know will be a very informative panel discussion and an impressive conference.
Few professional gatherings can match this one for the participants’ understanding of the regulatory process, not to mention the work and responsibilities of the FDA.
The talented professionals who comprise this organization have a unique grasp of the significance of the FDA’s regulatory regime and the processes necessary to ensure its continued effectiveness, as well as the worldwide regulatory landscape.
You understand that our work involves a careful balancing of scientific innovation and the need to ensure the safety and efficacy of medical products. It is a process that requires the analysis and application of the best available science and most rigorous data.
To this end, I’m sure you appreciate that criticisms of the FDA’s process as either too fast or too slow miss the point. The regulatory environment is a dynamic one, constantly being shaped by ongoing challenges and changes in public health and posing increasingly complex questions for regulators such as the FDA.
This process is even more daunting during public health emergencies. We were challenged to the utmost by the need for new diagnostics, vaccines, and therapeutics while at the same time dealing with all the disruptions to the development processes and regulation caused by the pandemic. For example, the need for more hand sanitizers led to innovation in getting temporary manufacturers such as distilleries into the game. Difficulties with trial conduct resulted in telemedicine innovations and ways to get informed consent on phones. FDA assisted with identifying food facility personnel and migratory farm workers who needed vaccination to keep our food supply chain open. CDRH innovated with umbrella EUAs to response to the large number of diagnostic products for COVID-19 that were needed. They also enabled ways to re-use certain devices safely in response to shortages.
CDER and CBER operated the CTAP to advance therapeutics quickly. We had to adapt our inspectional processes based on where the outbreaks were peaking. We operated remote assessments and made requests for records in cases where we could not reach facilities and these other processes might suffice. Several months ago we published our “resiliency” report on how we will resume a normal inspection pattern, while retaining some of the innovations. Our quality regulators across the Agency responded to shortages and need to open up new manufacturing space by enabling rapid startups of new lines and transfers of products. We issued reams of guidances explaining regulatory flexibilities and guidances. Every part of the Agency was and continues to be affected by the pandemic.
Our response to the SARS-COVID-19 virus offers a good example of how we continue to gather and apply new sources of data to respond quickly and effectively. This includes our efforts to speed the development, authorization and ultimately the approval of a safe and effective vaccine.
For vaccines, the FDA’s review process is one of the most comprehensive in the world. In the normal course of events, it relies on a manufacturer’s submission of a Biologics License Application (BLA). This application provides the FDA with a wealth of data and information, such as information about safety and effectiveness in the population who will receive the vaccine.
Manufacturers spend several months analyzing the data that they have obtained, and then submit it to FDA. As you regulatory professionals know, since you are often involved in the preparation and back and forth, a BLA can encompass tens of thousands of pages, and usually takes the agency many months to review. During this review period, FDA may present the data at a public advisory committee meeting for input, prior to making its final decision on whether to approve the vaccine.
Of course, public health emergencies, by their nature, demand faster responses. The Emergency Use Authorization (EUA), created by Congress after the 9/11 attacks, is an important regulatory tool. The EUA is designed to enable rapid availability and use of medical countermeasures and lifesaving products, including vaccines, during public health emergencies.
The FDA effectively has used the EUA to strengthen our response to the pandemic and help meet the unprecedented demand by issuing more than 400 EUAs covering nearly 800 medical products, including diagnostic tests, PPE, and, of course, the authorization, development, and distribution of three vaccines, including one that can be used in adolescents.
The process for issuing an EUA for a vaccine is speedier than the formal approval process, but the review of such an EUA is nonetheless supported by rigorous, scientific standards. For each COVID-19 vaccine that received emergency use authorization from the FDA, the agency evaluated data submitted by the manufacturer about the COVID-19 vaccine’s safety and effectiveness, and conducted its own analyses, before making the determination that the vaccine meets the standard for authorization.
The EUA is not the end of the line, however. As you know, we recently approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under EUA for all of the populations for which it is authorized.
The FDA’s extensive review relied not only on the company’s comprehensive submission, but also involved the agency’s independent analyses of the information in the BLA.
In addition to our work on the vaccines, FDA has endeavored to keep up with all its usual work, including premarket review of innovative products. One of the rate-limiting steps for some new products has been our inability to perform facility inspections in some locations. This has not happened to a lot of products, as detailed in our “Resiliency Report” but is a source of ongoing problems. We have resumed conducting domestic inspections and are performing certain ex-US inspections consistent with safety of our staff and various national requirements.
Also, as many of you know, we have been engaged in user free negotiations across a number of programs. Fortunately this essential activity can be carried on in the virtual environment, and we are making good progress.
Finally we have been engaged with implementing the priorities of the administration, which, beyond the COVID response, include topics such as the pharmaceutical supply chain and health equity.
One thing we have seen during this pandemic, at least among some people, is a renewed appreciation for the importance of science, technology, and data. It is reflected in the greater understanding we’ve seen of the essential role played by the FDA and other public health agencies, both in our response to this crisis and in our overall mission to protect and promote the health of the public.
I know that this group has always understood that role. As the name of this conference indicates, your meeting creates an important and valuable “convergence” of talented regulatory professionals, scientists, and innovators with a direct connection to the regulatory process.
I am confident that through your conversations, sharing of knowledge, and creative application of expertise, you will continue to play an important role in informing and strengthening the regulatory process. This will have a positive impact not only on public health, but also our nation as a whole.
I look forward to working with you to achieve these goals.