Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 6378) to reauthorize certain programs under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act with respect to…
Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 6378) to reauthorize certain programs under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act with respect to public health security and all-hazards preparedness and response, and for other purposes, as amended.
Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days in which to revise and extend their remarks and insert extraneous materials in the Record on the bill.
Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise today to speak in support of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018, known as PAHPA. I am proud to have introduced this important bill with Energy and Commerce Chairman Greg Walden, Ranking Member Frank Pallone, and my good friend Representative Eshoo, who is one of the original authors of the 2006 PAHPA bill and lead author of the last reauthorization in 2013.
This bipartisan public health and national security effort will ensure our Nation is better prepared to respond to natural disasters like hurricanes; emerging infectious diseases like Zika and Ebola; and chemical, biological, radiological, or nuclear attacks, whether from terrorist groups or from nation-states.
Seventeen years ago, Congress was the target of a biological attack when letters laced with anthrax arrived in Member offices just days or soon after the 9/11 terrorist attacks. In the aftermath of 9/11, the Blue Ribbon Study Panel on Biodefense was formed. It was led by bipartisan leaders: former Senator Joe Lieberman, former Governor Tom Ridge, and many others.
In October 2015, after extensive discussions around the country where they learned from experts, they created their ``National Blueprint for Biodefense,'' which provided us with a roadmap in drafting this important legislation.
I was the United States Attorney for the Southern District of Indiana during those 2001 anthrax attacks, and my own office dealt with an anthrax hoax when we received a letter with white powder inside. Of course, at the time, we didn't know it was a hoax. It was incredibly stressful for that staff member, who had to worry about their very own health. But that personal experience illustrated to me the importance of preparedness and sparked my interest in biodefense.
In the years since then, we know that the threat of a chemical, biological, radiological, or nuclear incident continues to grow. Every day, our adversaries are looking for more effective and faster ways to reduce the threat. It is not really a question of if we face the threat. It is a question of when.
Thanks to PAHPA and the 21st Century Cures Act, we are more prepared than ever for biological threats and attacks.
In July of just this last year, the FDA approved the first drug to treat smallpox. It is called TPOXX. But TPOXX isn't the only recent approval at the FDA. In July, the FDA also approved an autoinjector that provides a one-time dose of an antidote to block effects of a nerve agent. This new antidote and TPOXX will help protect Americans from biological attacks.
But PAHPA is much more than just a biodefense bill. It also ensures a coordinated healthcare response, whether to hurricanes or other natural disasters.
Florence has just hit the East Coast and residents in both North and South Carolina are still recovering and dealing with ongoing flooding. During the 2017 hurricane season, whether it was Hurricane Harvey, Irma, Jose, or Maria, far too many Americans were killed. It showed us that we need to do better to prioritize the needs of every person in our communities.
The PAHPA bill we are considering today does just that. It prioritizes our Nation's most vulnerable populations: our children, senior citizens, and those with disabilities. It reauthorizes the advisory committee focused on the specific needs of children and creates new advisory committees to ensure the needs of the elderly and those with disabilities are considered.
The bill provides liability protections for healthcare professionals who volunteer after medical disasters. In addition to these types of Good Samaritan provisions, the bill ensures more healthcare professionals like nurses, doctors, and others can be hired and trained when facing a public health crisis by strengthening our National Disaster Medical System, which provides grants to our regional healthcare network.
It also ensures we have a robust supply of vaccines and basic equipment like gloves, hazmat suits, masks, personal protective gear, and more in our strategic national stockpiles located all across the country, so that our healthcare professionals and first responders have what they need.
PAHPA ensures our preparedness and response capabilities will include a robust pipeline of medical countermeasures by reauthorizing and increasing funding for the BioShield Special Reserve Fund and BARDA, the Biomedical Advanced Research and Development Authority.
BARDA's work over the last decade has resulted in FDA approvals for more than 42 different medical countermeasures. The development of medical countermeasures is a lengthy and often risky endeavor, which is why sending a clear signal that BARDA remains a strong and committed partner with academic institutions and the private sector in these efforts is so very important.
Last week, we saw even another example of a success of research funded by BARDA when FDA approved a product called ReCell, the first spray-on skin product ever approved for use in the United States. This new treatment will help treat burn victims so they can heal faster and with less risk of infection from painful skin grafts. By using a piece of a patient's skin about the size of a credit card, a doctor can turn it into a single cell-based solution that can be sprayed over the patient's burns so that new skin can grow and replace the damaged skin.
These types of investments BARDA is making into innovative research are critical, but it is also important that we continue to address threats that have been around for years.
It has been 100 years since the 1918 pandemic influenza killed millions of people around the globe, including 675,000 Americans. Some experts predict that we are actually due for the potential of another global pandemic influenza.
To address that threat, the bill we are considering today authorizes $250 million for the Assistant Secretary for Preparedness and Response, the ASPR, to address threats like pandemic influenza. Specifically, the bill directs the ASPR to work to increase manufacturing capacity and stockpile medical countermeasures.
While the PAHPA bill we are considering today authorizes funding for research into known threats like pandemic influenza, it also maintains the flexibility that is the foundation of our medical countermeasure enterprise to deal with unknown threats for which we may have no defense today.
Even today, the Democratic Republic of the Congo continues to deal with an ongoing Ebola outbreak. In order to ensure we are better prepared when we face an outbreak like Ebola or Zika, the bill we are considering today does three important things.
First, it improves the existing emergency response fund so that the Secretary of Health and Human Services does not have to wait on approval from Congress to immediately fund response measures needed to contain an outbreak and save lives. This emergency response fund will create a bridge so that immediate funding is available, so we can then supplement with an emergency appropriations bill later.
Secondly, the bill requires GAO to conduct a review of the emergency response fund to help appropriators decide what funding levels and resources are needed.
The third thing the bill does to help address threats like Ebola and Zika is to authorize $250 million in funding for an emerging infectious disease program so that BARDA can invest in new research.
The PAHPA bill reauthorization we are considering is the process of months of committee work in both the House and the Senate, and I want to thank all the staff members and all of the organizations, everyone who has been involved, and all the Members who have participated, whether it is subcommittee or committee hearings on this bill, examining our response to threats. I thank everyone involved for their dedication and commitment to
making sure we have the procedures, resources, and support in place to protect our fellow citizens from public health and national security threats.
I can't emphasize enough how critically important it is to reauthorize PAHPA. We have a duty as Members of Congress to keep Americans safe and secure. This bill is an essential component of accomplishing that goal. I urge all Members to support this critical bipartisan piece of legislation.
Mr. Speaker, I include in the Record letters from many organizations that support the bill.
Adult Vaccine Access Coalition,
July 23, 2018.
Hon. Susan W. Brooks,
Member of Congress,
Washington, DC.
Hon. Anna Eshoo,
Member of Congress,
Washington, DC.
Dear Representatives Brooks and Eshoo: On behalf of the
Adult Vaccine Access Coalition (AVAC), we are pleased to
express our support for bipartisan legislation that recently
passed the House Energy and Commerce Committee, ``Pandemic
and All-Hazards Preparedness Reauthorization Act (PAHPA) of
2018''.
AVAC includes more than fifty organizational leaders in
health and public health who are committed to raising
awareness of and engaging in advocacy on the importance of
adult immunization. AVAC priorities and objectives are driven
by a consensus process with the goal of enabling stakeholders
to have a voice in the effort to improve access to and
utilization of adult immunizations.
The bipartisan reauthorization of the PAHPA provides
improvements to key preparedness and response programs,
enhances personnel and hiring authorities, as well as
prioritizes cybersecurity in health care and provides
necessary resources for the development of medical
countermeasures for pandemic influenza and emerging
infectious diseases. We are delighted the Managers' Amendment
included references to immunization programs and immunization
information systems under Section 319D. These additions will
help to strengthen and enhance coordination and integrate
immunization programs and immunization information systems
(IIS) capabilities into public health emergency preparedness,
planning, and response activities.
Immunization Information Systems (IIS), or registries,
confidential, population-based, computerized systems can
record immunization doses administered by participating
providers to persons residing within a given jurisdiction.
They provide state and local public health agencies aggregate
data on immunization coverage rates for disease surveillance
and program operations. IIS' can serve as a vital component
for emergency preparedness and response activities and are an
optimal tool for use during a pandemic or other emerging
infectious disease event by enabling communication with
providers, identifying variations in access and utilization
of immunization, and enabling implementation of targeted
strategies during emergency preparedness and response
activities.
Congratulations on putting together a strong, bipartisan
reauthorization package that reflects many of the important
priorities shared by stakeholders. We look forward to working
with you throughout the process to enact the 2018 Pandemic
and All-Hazards Preparedness Reauthorization Act.
Sincerely,
Lisa Foster,
AVAC Manager.
Abby Bownas,
AVAC Manager.
Mr. Speaker, I reserve the balance of my time.
House of Representatives,
Committee on Homeland Security,
Washington, DC, September 24, 2018.
Hon. Greg Walden,
Chairman, Committee on Energy & Commerce,
Washington, DC.
Dear Chairman Walden: I write concerning H.R. 6378, the
``Pandemic and All-Hazards Preparedness and Advancing
Innovation Act of 2018''. This legislation includes matters
that fall within the Rule X jurisdiction of the Committee on
Homeland Security.
In order to expedite floor consideration of H.R. 6378, the
Committee on Homeland Security will forgo action on this
bill. However, this is conditional on our mutual
understanding that forgoing consideration of the bill would
not prejudice the Committee with respect to the appointment
of conferees or to any future jurisdictional claim over the
subject matters contained in the bill or similar legislation
that fall within the Committee's Rule X jurisdiction. I
request you urge the Speaker to name members of the Committee
to any conference committee names to consider such
provisions.
Please place a copy of this letter and your response
acknowledging our jurisdictional interest in the
Congressional Record during House Floor consideration of the
bill. I look forward to working with the Committee on Energy
and Commerce as the bill moves through the legislative
process.
Sincerely,
Michael T. McCaul,
Chairman.
Mr. Speaker, I yield 5 minutes to the gentleman from Oregon (Mr. Walden), the chairman of the Energy and Commerce Committee.
Mr. Speaker, I yield 5 minutes to the gentleman from Texas (Mr. Burgess), the subcommittee chair for the Subcommittee on Health.
Mr. Speaker, I yield 1 minute to the gentleman from Florida (Mr. Bilirakis), who also serves on the Subcommittee on Health.
Mr. Speaker, I yield myself the balance of my time.
Mr. Speaker, I would like to particularly thank Dr. Burgess and the ranking member of the Subcommittee on Health, Gene Green, for their leadership in working with so many of us who have brought this legislation to the floor at this time.
It is really so very critical that all relevant Federal agencies, particularly the leadership of CDC and the ASPR, work together with our local and State partners that are truly on the ground; and I certainly urge my colleagues to
pass this important piece of legislation not only to ensure that public health is of paramount importance in this country, but, also, because this is an incredibly important piece of national security legislation.
Mr. Speaker, I yield back the balance of my time.
Mr. Speaker, I include the following letters in the Record.
Health Industry
Distributors Association,
July 17, 2018.
Hon. Greg Walden,
Chairman, House Energy and Commerce Committee, House of
Representatives, Washington, DC.
Hon. Susan Brooks,
House of Representatives, Washington, DC.
Hon. Frank Pallone,
Ranking Member, House Energy and Commerce Committee, House of
Representatives, Washington, DC.
Hon. Anna Eshoo,
House of Representatives,
Washington, DC.
Dear Chairman Walden, Ranking Member Pallone, Congresswoman
Brooks and Congresswoman Eshoo: On behalf of the Health
Industry Distributors Association (HIDA), we appreciate the
opportunity to express our support for H.R. 6378, the
Pandemic and All-Hazards Preparedness and Advancing
Innovation Act of 2018 (PAHPAI). HIDA commends you for your
leadership on this issue and appreciates the active
engagement of your staff with industry to incorporate lessons
learned from recent events such as Ebola and the 2017
hurricane season, in H.R. 6378, to continually improve our
nation's preparedness capabilities.
HIDA is the trade association representing medical products
distributors, all of which deliver medical products and
supplies, manage logistics, and offer customer services to
more than 294,000 points of care. HIDA members primarily
distribute items used in every day medical services and
procedures, ranging from gauze and gloves to diagnostic
laboratory tests. Their customers include over 210,000
physician offices, 6,500 hospitals, and 44,000 nursing home
and extended care facilities throughout the country, as well
as numerous federal agencies and their healthcare facilities.
As you know, the medical supply chain plays a critical role
in preparedness, as it supplies key infection prevention
products and protective equipment such as respirators, face
shields, hoods, impermeable gowns and gloves to first
responders and health care providers. Additionally, the
medical supply chain is the primary source for the diagnostic
and point-of-care rapid tests needed to identify infectious
disease, as well as the ancillary products such as gloves,
needles and syringes needed to deliver medical
countermeasures effectively.
HIDA and its members have collaborated with federal
agencies on identifying opportunities to improve coordination
and develop solutions that create more elasticity in the
supply chain for key products. One of the many lessons
learned during the 2017 hurricane season was a considerable
need to improve coordination during an emergency response,
ensuring appropriate infrastructure partners are included in
a prioritization process for access to affected areas after
an event. We appreciate the Committees' acknowledgement of
the importance of this issue in the legislation, as well as
the recognition of the healthcare supply chain in H.R. 6378.
Specifically, we support the following:
Section 101 provisions important to the healthcare supply
chain including
The value of public and private sector coordination during
an event to ensure critical supplies are delivered and
information is shared.
The requirement that ancillary products needed to deliver a
medical countermeasure are incorporated into the Public
Health Emergency Medical Countermeasure Enterprise planning
process.
Section 319C-3 provisions that create a regional healthcare
system plan and that it be communicated to supply chain
partners so needed product can be redirected during a
response.
HIDA thanks you for your continued commitment to
preparedness and look forward to working with you on H.R.
6378.
Sincerely,
Linda Rouse O'Neill,
Vice President, Government Affairs,
Health Industry Distributors Association.
Mr. Speaker, I include the following letters in the Record.
American Society
for Microbiology,
Washington, DC, July 23, 2018.
Hon. Paul Ryan,
Speaker of the House, House of Representatives, Washington,
Mr. Speaker, I include the following letters in the Record.
Cerus,
Concord, CA, July 17, 2018.
Hon. Greg Walden,
Chairman, House Energy and Commerce Committee, House of
Representatives, Washington, DC.
Hon. Frank Pallone,
Ranking Member, House Energy & Commerce Committee, House of
Representatives, Washington, DC,
Dear Chairman Walden and Ranking Member Pallone: As you
review and deliberate over H.R. 6378, the Pandemic and All-
Hazards Preparedness and Advancing Innovation Act of 2018, we
wanted to provide our support for the efforts in the
legislation to preserve and protect the nation's blood
supply--especially in a public health emergency.
As you know, the American public expects the nation's blood
supply is safe and available every day, but especially in
situations of natural or man-made disasters. Blood
transfusions can be lifesaving measures, but this depends on
our collective ability to ensure the safety and availability
of the blood supply. Though the danger of transfusion-
transmitted infections has decreased in recent years due to
improved blood testing for specific pathogens such as HIV and
hepatitis, these tests do not detect the presence of all
viruses, bacteria, and parasites known to contaminate blood
donations. In 2015 at the height of the Zika epidemic in
Puerto Rico, the FDA released guidance calling for the use of
blood treatment pathogen reduction technology as an option to
reduce the risk of transfusion-transmission of Zika. This
pathogen reduction technology helped ensure that very ill
patients would have adequate access to safe blood and that
they would not contract Zika virus infection from their
therapeutic blood transfusions.
Section 116 is critical to ensuring the blood collection
community, in concert with the Department of Health and Human
Services, begins to cohesively examine the challenges with
preserving capacity in the nation's blood supply for major
emergency care, addressing issues like recruiting sufficient
donors to ensure the adequacy of the current supply to meet
public health emergencies and implementation of innovative
and best safety practices.
The inclusion of blood banks in Section 203 is also
critical for ensuring the blood banking community has an
opportunity to engage along with hospitals, health care
facilities, public agencies and others to provide input into
our nation's new ``Healthcare Preparedness and it Response
Program.'' The inclusion of blood banks is critical in
providing feedback on the financial implications for the
program as the industry faces many challenges in ensuring a
transfusion-ready blood supply.
I sincerely appreciate the time and effort that both of
you, your fellow Committee members and the staff have placed
in drafting, reviewing, and deliberation over H.R. 6378. I
look forward to continuing to work with all of you in
supporting our nation's ability to respond in public health
emergencies.
Sincerely,
Dr. Laurence Corash, MD
Chief Scientific Officer, Cerus.
Mr. Speaker, I include the following letters in the Record.
July 18, 2018.
Hon. Susan Brooks,
Washington, DC.
Hon. Anna Eshoo,
Washington, DC.
Dear Representatives Brooks and Eshoo: I am writing on
behalf of Roche Diagnostics Corporation in support of H.R.
6378, Pandemic and All-Hazards Preparedness and Advancing
Innovation Act of 2018. Congratulations on advancing this
legislation out of the Energy and Commerce Committee.
We applaud your efforts in improving the nation's overall
preparedness and response capabilities. We especially
appreciate the Committee's recognition that diagnostics can
play a key role in responding to public health and medical
emergencies.
We look forward to continuing to work with you as this
legislation advances in Congress.
Sincerely,
Russell C. Ring,
Vice President, Government Affairs,
Roche Diagnostics Corporation.