Community Services Block Grant Enhancement Act of 2020

Mr. Speaker, I yield myself such time as I may consume.

We often hear it said that life is a multiple of threes, and here we are, the third time, passing this important legislation.

One hundred years ago, this country was in the midst of the worst pandemic in its history, claiming the lives of almost 700,000 Americans and killing more than 50 million people worldwide.

As we discuss the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, it is paramount that we remember the significance of the centennial anniversary of the 1918 influenza pandemic.

I must also note, again, the third time the House has passed this legislation. We have clearly done our work, and it is time for the other body to do their work and send this bill to the President's desk.

The creation of the Assistant Secretary for Preparedness and Response under the original legislation in 2006 has helped us to make monumental strides in preparedness, coordination, and response.

Close collaboration and efforts between the Centers for Disease Control and Prevention, the Food and Drug Administration, and our State, local, Tribal, and territorial public health partners have been vital in making this progress.

Like politics, much of public health is local and executed on the ground by our hospitals, by our health departments and our emergency responders, who are our front lines in addressing infectious diseases, disasters, and threats.

We hear each and every year of the dangers of the influenza as flu season wreaks havoc on communities across the country. Last year, in north Texas, some schools had to close in order to contain the spread of the flu. This bill includes an important provisio dedicated to preparing for pandemic influenza to protect our Nation against the terror of a pandemic.

Mr. Speaker, I would just parenthetically add that if anyone has not yet had their influenza immunization this year, it is still a good idea to avail yourself of that protective measure. The flu vaccine not only can prevent the flu, but if someone gets the flu after having had the flu vaccine, their clinical course is likely to be more benign.

This reauthorization includes an important provision, the MISSION ZERO Act. The MISSION ZERO Act seeks to connect American patients with battle-tested trauma care through the craft of military trauma care providers.

The bill provides grants to integrate military trauma care providers and teams into the Nation's leading trauma centers and systems. This will also ensure that our military can maintain battlefield-ready trauma care providers in between periods of active engagement. The need for top-notch trauma care extends across our Nation, far removed from the battlefield.

We must also remember that infectious diseases are a much more serious threat in the global community, and we must continue to ensure that we are prepared and ready to respond. Frontline facilities and responders in Dallas, Texas, experienced this firsthand in 2014 when a patient presented with Ebola in a DFW emergency department.

Today, currently, right now, there is an Ebola outbreak in the Democratic Republic of the Congo that has been deemed the second worst on record, with more than 600 cases. This legislation equips our Nation with the tools to respond in a timely and effective manner when the public health and safety are at risk, such as if Ebola were to hit the United States again.

Additionally, this bill will also help to bring domestic biologic surveillance systems up to date so that they are operating with the most efficient capabilities and technologies.

We must also look for innovative ways to continue to advance medical countermeasures, ensuring that Americans can access medications that will provide critical protection in the future.

Another portion of this legislation would modernize the regulation of over-the-counter medicines. To date, consumers have access to more than 300,000 nonprescription items, from cough to cold medicines to antiperspirants, antacids, and sunscreens. Pharmacy aisles and medicine cabinets are filled with over-the-counter products, and American consumers rely on these each and every day.

This bill would make the over-the-counter regulatory framework more science-based and responsive to public health concerns, and it would encourage the development of more innovative products and provide resources to the Food and Drug Administration to bolster the agency's ability to review over-the-counter applications and to regulate this sector in a consistent manner.

This Pandemic and All-Hazards Preparedness reauthorization is critical to protecting the lives of all Americans and providing the necessary tools and infrastructure are in place when disaster strikes.

I want to thank Representatives Susan Brooks and Anna Eshoo for their work and Representatives Bob Latta and Diana DeGette for their work on the over-the-counter monograph reform.

I strongly support this legislation, urge Members to do the same, and I reserve the balance of my time.

Mr. Speaker, I yield 3 minutes to the gentleman from Ohio (Mr. Latta).

Mr. Speaker, I yield 4 minutes to the gentlewoman from Indiana (Mrs. Brooks), the principal author of the bill.

Mr. Speaker, I yield 2 minutes to the gentleman from Kentucky (Mr. Guthrie).

Mr. Speaker, I urge all Members to support the bill before us today, and I yield back the balance of my time.

Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 269) 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, to clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes.

Mr. Speaker, I ask unanimous consent that all Members have 5 legislative days to revise and extend their remarks and include extraneous materials on H.R. 269.

Mr. Speaker, I yield myself such time as I may consume.

I rise to voice my support for the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019. This legislation will help strengthen our Nation's emergency preparedness and response efforts. It will also modernize the regulatory

framework for over-the-counter drugs and provide FDA with stable and consistent funding to oversee the over-the-counter market.

This bill would ensure our Nation is prepared and can respond to emerging infectious disease threats, including Zika and Ebola. It will also prepare us so we can better respond to health security events, like bioterrorism and natural disasters such as hurricanes and wildfires.

The importance of this law cannot be overstated, Mr. Speaker. That is why our committee committed to working together in the last Congress on a bipartisan basis to ensure that the important authorities granted to the FDA in this law did not lapse.

I want to especially thank Representatives Eshoo and Brooks for their work on this legislation and their leadership in promoting the importance of strengthening our Nation's emergency preparedness and response infrastructure.

While the House passed legislation that would have prevented this authorization from expiring, the Senate then refused to act and, instead, allowed these important authorities to expire on September 30.

While we were disappointed that we were unable to reauthorize PAHPA before that occurred, we continued to work with our Senate colleagues on moving this important legislation forward before the end of the 115th Congress. That effort led to the passage of H.R. 7328 on December 20, legislation developed as a result of bipartisan, bicameral negotiations to reach agreement on a PAHPA reauthorization bill that we could all support.

Unfortunately, just like before, the Senate did not act; and, thus, we are on the floor again today, Mr. Speaker, moving legislation to reauthorize the Pandemic All-Hazards Preparedness Act and pass historic legislation to streamline and fund the regulation of over-the-counter drugs. I hope that the third time will be the charm and that our Senate colleagues will act quickly to pass this legislation.

In addition to reauthorizing our public health preparedness and response programs, this legislation also contains a bipartisan and bicameral agreement reforming our over-the-counter drug program.

The Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 has also twice previously passed the House with overwhelming bipartisan support. It modernizes the way the FDA reviews over-the- counter products for colds, allergies, and other common health issues.

The bill streamlines the review process for future monograph changes, allows for expedited safety label changes, and establishes a user fee program to provide reasonable or sustainable resources to implement these reforms.

These are all critical changes that I am very proud to support.

While this is not a perfect bill and still contains unnecessary and unwarranted exclusivity for over-the-counter drugs and sunscreens, reform of our over-the-counter drug program is long overdue. This reform will pave the way for innovation in the over-the-counter market, allow the agency to respond to safety events, and finally provide the agency with the resources needed to properly oversee this growing market.

This legislation has the broad support of industry, public health groups, and the FDA, and it deserves the support of both the House and the Senate.

I want to thank the bill's authors, Representatives Eshoo, Brooks, DeGette, Latta, Dingell, Guthrie, and Burgess, for their hard work on this legislation.

It is my hope that the Senate will now take swift action and move this legislation to the President's desk. I urge my colleagues to vote in support of this legislation.

Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, I yield 3 minutes to the gentlewoman from Michigan (Mrs. Dingell).

Mr. Speaker, I have no additional speakers, and I reserve the balance my time.

Mr. Speaker, I have no additional speakers and am prepared to close. I reserve the balance of my time.

Mr. Speaker, again, I would ask support for this bipartisan bill. It is very important legislation, and I hope that we can send it to the Senate and have the President quickly sign it.

Mr. Speaker, I yield back the balance of my time.

Mr. Speaker, on that I demand the yeas and nays.

Mr. Speaker, I rise today in support of H.R. 269, the ``Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019.''

H.R. 269 reauthorizes and strengthens emergency preparedness and response programs and efforts Health and Human Services (HHS) and modernizes the regulatory framework at the Federal Drug Administration (FDA) for over-the-counter (OTC) drugs and provide the FDA with stable funding to do so through a new user fee program.

H.R. 269 strengthens HHS's emergency preparedness and response by improving benchmarks and standards, addressing military and civilian partnerships for trauma readiness, and clarifying state liability law for volunteer health care professionals.

Additionally, H.R. 269 calls for reporting on the national blood supply and public health preparedness and response capabilities and capacities of hospitals, long-term care facilities, and other health care facilities.

H.R. 269 also allows for the regulation of certain nonprescription drugs that are marketed without an approved drug application, addresses the misbranding of OTC drugs, and calls for an annual update to Congress on the conditions under which certain OTC cough and cold drugs are generally recognized as safe and effective for children.

H.R. 269 grants authority to assess and use OTC monograph fees as a source of stable funding to the FDA for its use to modernize the regulatory framework.

This legislation will benefit all communities by strengthening and assessing the emergency response workforce, improving the preparedness and response of health system infrastructure, taking into consideration at-risk individuals and children, providing guidance for participation in exercises and drills, and create national advisory committees on disasters.

In 2014, Dallas, Texas was faced with an Ebola virus outbreak, one of the world's most deadly viruses.

Howard Duncan was visiting family in Dallas when he became the first person diagnosed with Ebola in the United States.

In addition to Duncan, two nurses who provided care to him also became infected.

Zika made its first appearance in Texas in 2015.

In 2016 Texas had 315 cases of Zika, and in 2017, 55 cases were confirmed.

2017 brought a high severity flu season along with Hurricane Harvey.

80,000 people died of the flu during the 2017 through 2018 season and over 30,000 people, or 9 percent of the population, were hospitalized.

The severity of the 2017-2018 flu season was in part due to the flu vaccine, unfortunately, only being effective against only 30 percent of the viruses circulating.

Also in 2017, the 18th District of Texas and the Gulf Coast saw the devastation of Hurricane Harvey.

The economic cost of Hurricane Harvey was $125 billion, tying it with Hurricane Katrina as the most costly storm in U.S. history.

More importantly, 107 people lost their lives due to Hurricane Harvey.

Then there is the ongoing shortage of medical supplies, specifically saline solution.

Since 2014 there has been an ongoing shortage of saline, and when Hurricane Maria hit Puerto Rico in 2017, the country's largest supplier was damaged causing an even larger shortage.

The saline shortage coupled with a severe flu season in 2017-2018 has some worried that the demand will quickly outpace the supply.

H.R. 269 will help address these and other local, state, and national emergencies.

Not only does H.R. 269 address HHS emergency preparedness, but it also allows the FDA to better do its job to keep Americans safe.

In 2018, the FDA issued at least 1,412 warning letters regarding the misbranding of products under its jurisdiction.

An alarming number of these letters regard OTC drugs and supplements.

H.R. 269 provides the FDA a stable funding source so that it may continue its regulation of

certain nonprescription drugs that are marketed without an approved drug application and address the misbranding of OTC drugs.

For these reasons, I ask my colleagues to join me in supporting H.R. 269.

Mr. Speaker, I rise today in support of H.R. 269, the Pandemic and All-Hazards Preparedness and Advancing Innovation Act, or PAHPA.

I am proud to have introduced this important bill with my very good friend, Representative Anna Eshoo, who is one of the original authors of the 2006 PAHPA bill and the lead author of the last reauthorization in 2013.

Mr. Speaker, I want to thank Energy and Commerce Committee Chair Representative Pallone and Ranking Member Representative Walden, as well as Representative Burgess for his work on the Health Subcommittee, and the committee staff for working to get this bill back on the House floor so quickly as we begin the 116th Congress.

PAHPA is a bipartisan public health national security effort which works to ensure our Nation is better prepared to respond, whether it is to natural disasters like hurricanes, emerging infectious diseases like Zika or Ebola, or chemical, biological, radiological, or nuclear attacks, whether they might come from a terrorist group or from a nation-state.

The reality is that these threats we face are not just hypothetical. The ongoing Ebola outbreak is now, as you have already heard, the second largest outbreak in history. Since August of 2018, 374 people in the Democratic Republic of the Congo have died from Ebola, bringing the total to 623 cases. Nine new cases have been confirmed in just the last week alone.

Thanks to PAHPA and the 21st Century Cures Act, we are more prepared for biological threats and attacks. Last year, the FDA approved the first drug to treat smallpox and also an auto injector which provides a one-time dose of an antidote to block effects of a nerve agent.

But PAHPA is much more than what we think of as just a biodefense bill. It helps ensure a coordinated healthcare response, whether it is to hurricanes and other natural disasters, by prioritizing our Nation's most vulnerable populations: children, senior citizens, and people with disabilities.

PAHPA provides liability protection for physicians who volunteer after medical disasters. It ensures more healthcare professionals, nurses and doctors and others, can be hired and trained when facing a public health crisis. It ensures we have a robust supply of vaccines and equipment like gloves,

hazmat suits, and masks in our Strategic National Stockpiles so our medical professionals and our first responders have what they need.

The bill ensures our preparedness and response capabilities will include a robust pipeline of medical countermeasures by increasing funding for the BioShield Special Reserve Fund and BARDA, whose work over the last decade has resulted in FDA approvals for more than 42 different medical countermeasures.

While the investments BARDA is making into innovative research and treatments are critical, we have to address the threats that have been around for years.

As Mr. Burgess talked about, the 1918 influenza outbreak killed 675,000 Americans and millions worldwide. Many experts predict that we are due for another global pandemic influenza. The bill today authorizes $250 million to address threats like pan flu.

This bill is the result of months of committee work in both the House and the Senate. I can't emphasize enough how critically important it is that we reauthorize PAHPA.

Mr. Speaker, I encourage the Senate to quickly pass H.R. 269. I urge all Members to support this critical piece of public health and national security legislation.

Mr. Speaker, I thank the chairman for yielding me the time.

I rise in strong support of H.R. 269. This important bill reauthorizes the Pandemic and All-Hazards Preparedness Act and provides FDA with needed revenue and authority to improve oversight of over-the- counter drugs.

The House of Representatives overwhelmingly passed this bipartisan legislation at the end of the 115th Congress, and I am pleased that we are acting on this bill once again at the beginning of the 116th Congress. I am proud to have helped introduce this legislation, and I urge my Senate colleagues to quickly pass this bill into law.

My chairman, Mr. Pallone and Representative Burgess have talked and spoken well of why we must address the Pandemic and All-Hazards Preparedness Act. Headlines in the Detroit paper today talking about a death in an area hospital because of a power outage is why we must prepare these institutions to be ready for crises, but I want to speak about the over-the-counter part of this bill.

Today, 60 percent of all medicines sold in the United States are over the counter. Americans trust that they are safe, yet the FDA has only 18 full-time employees--only 18--to oversee the entire market of drugs sold across this country.

This outdated system has the potential to put patients at risk and does not match the realities of our modern healthcare system.

The bill we are discussing today reforms this system for the better. It creates a new user fee program to give FDA the resources it needs to improve public health. It also improves the efficiency by allowing the agency to update OTC monographs through administrative order rather than the rulemaking process.

These changes are a big win for patients, who will benefit from improved product safety, and for industry, as they will have a reliable pathway to bring new, innovative products to market. It has been years since a new sunscreen product has been brought to market simply because of this outdated system.

I want to thank my colleagues on the Energy and Commerce Committee for all the time and effort they put into this legislation; to Representatives Eshoo and Brooks, who worked so hard on the Pandemic and All-Hazards Preparedness Act; and to my colleague, Representative DeGette, and my Republican colleagues, Representatives Latta, Guthrie, and Burgess, for all the work that they did.

We need to get this important bill passed and into law. I urge my colleagues to support H.R. 269.