- For Immediate Release:
- Statement From:
Statement AuthorLeadership RoleDeputy Commissioner for Policy, Legislation, and International Affairs - Food and Drug Administration ( - )
Chairman Burgess, Ranking Member Green, and members of the committee, thank you for the opportunity to appear today to discuss reauthorization of the Pandemic and All-Hazards Preparedness Act or PAHPA. Medical and public health preparedness and response is of critical importance to the health and security of our Nation and I am pleased to be here today to share how FDA is working toward the shared goal of making sure we have the medical products we need to protect Americans from a range of public health threats, whether naturally-occurring, or deliberate.
We are reminded of the urgency and need to remain ever vigilant against identified and emerging public health threats as we carefully monitor the current outbreak of Ebola virus disease, this time in the Democratic Republic of Congo. I can assure you that the FDA is dedicated to helping end this outbreak as quickly as possible, and we are actively engaged with our federal colleagues testifying here with me today, as well as with medical product developers, and international organizations—including the World Health Organization—to support international response efforts.
This most recent Ebola outbreak accentuates the continuing threat posed by emerging infectious diseases—which can and often do emerge with little to no warning—and the need for us to continue to optimize our preparedness and response capabilities.
PAHPA, which was passed in 2006 and reauthorized in 2013, is a key piece of legislation that—along with other significant legislative achievements—has served to significantly strengthen our Nation's preparedness and response capabilities to respond to public health emergencies involving chemical, biological, radiological, and nuclear—or CBRN—threats, as well as emerging infectious disease threats, such as Zika virus, Ebola virus, and pandemic influenza.
Prior to joining FDA, I worked for more than a decade on health care policy with your colleagues in the United States Senate, serving as the Health Policy Director for Senator Richard Burr, from North Carolina, on the Health, Education, Labor, and Pensions Committee for many years. In that capacity, I collaborated with colleagues serving in the United States House of Representatives, including this Committee, [and it’s nice to see some of those colleagues in this room here today]. I was actively involved in working on a range of health care issues and my tenure was very much highlighted by my work on medical and public health preparedness and response issues, including the bipartisan 2013 PAHPA Reauthorization Act—or PAHPRA—and, more recently, the 21st Century Cures Act.
PAHPRA recognized the key role FDA plays in emergency preparedness and response, and codified and built on FDA’s ongoing efforts to augment review processes and advance regulatory science to enable better response to public health emergencies and emerging health threats. The provisions in PAHPRA have been critical to FDA’s efforts to help drive innovation in the medical countermeasure space and have provided FDA with essential tools that continue to support us in our mission to protect and promote public health.
At FDA, we have made it a priority to utilize these authorities to proactively work with our private sector and government partners to help facilitate the translation of discoveries in science and technology into safe and effective medical countermeasures as part of advancing public health and strengthening our national security. We share Congress’ goal to have safe and effective medical countermeasures available in the event they are needed and we have made key progress towards this important goal. As of the end of fiscal year 2017, FDA has approved, licensed, or cleared 121 medical countermeasures, including supplements to approvals, licensed, and cleared medical products. We have issued more than 60 Emergency Use Authorizations since 2005, including about 40 since 2013, including for Zika and Ebola. Medical countermeasures can face unique development challenges that require medical product sponsors to rely on animal models because human efficacy trials would not be ethical. PAHPRA required FDA to issue final guidance regarding the development of animal models to support the approval and clearance of medical countermeasures. FDA finalized this guidance in October 2015, and, to date, 13 medical countermeasures have been approved under the Animal Rule, including the approval of a new indication for a medical countermeasure to increase survival of adult and pediatric patients acutely exposed to myelosuppressive doses of radiation as could occur after a radiological or nuclear event. This is the third FDA-approved medical countermeasure that is indicated to increase survival in patients exposed to myelosuppressive doses of radiation. Other approvals under the Animal Rule include inhalational anthrax therapeutics, a botulism antitoxin, antibiotics for the treatment and prophylaxis of plague, prophylaxis against the lethal effects of soman nerve agent poisoning, and treatment of known or suspected cyanide poisoning.
We have also been actively implementing new authorities within our Medical Countermeasures Initiative specific to our engagements with the Department of Defense. In January 2018, the Agency launched enhanced engagements with the Department of Defense under a joint program to prioritize the efficient development of safe and effective medical products intended for U.S. military personnel. We are fully committed to closely working with our colleagues at the Department of Defense to support the needs of U.S. military personnel and look forward to continuing enhanced collaborations in these important endeavors.
Finally, I’m pleased to share that today we are releasing our Medical Countermeasures Initiative Program Update, which highlights the many notable achievements the Agency has made to advance the development and availability of medical countermeasures in fiscal year 2017. The report provides in-depth insight into the breadth of the activities and the progress FDA has contributed to the Nation’s medical countermeasure assets.
FDA remains deeply committed to working closely with its partners and fully using the authorities Congress provides to help facilitate and accelerate the development and availability of safe and effective medical countermeasures. We greatly appreciate Congress’s support in working with us to continually optimize our authorities—and providing resources—to enable FDA to achieve its mission. While we have made significant progress in our preparedness work, we know that more work remains to be done, and look forward to partnering with Congress and stakeholders as we work together to further enhance this critical work as you consider legislation to reauthorize PAHPA.
Thank you for inviting FDA to testify today. I was proud to have seen PAHPRA through the legislative process during my time in the Senate, and I’m grateful to now have the privilege to work on its implementation at FDA. I look forward to answering any questions you may have.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
- Tara Rabin