Date: 2016-04-12
Speaker: JACKSON LEE (democrat)
Chamber: H

Mr. Speaker. I rise to speak in support of S. 2512. the Adding Zika Virus to the FDA Priority Review Voucher Program Act. This bill amends the Federal Food. Drug. and Cosmetic Act to add the Zika virus to the list of tropical diseases under the priority review voucher program. which awards a voucher to the sponsor of a new drug or biological product that is approved to prevent or treat a tropical disease. A voucher entitles the holder to have a future new drug or biological product application acted upon by the Food and Drug Administration within six months. My support has been steadfast. since I signed a letter at the virus onset. urging the FDA to quickly exercise the authority provided by Congress to add the Zika virus to the Neglected Tropical Disease list. I thank local. state and national health care professionals. public servants and others who have instituted preventative measures to combat the public health and safety threat that the Zika virus poses to our nation and our Western Hemisphere neighbors. The Zika virus. spread primarily through mosquitos and first detected decades ago in Uganda. has now begun to spread rapidly in South America. The recent outbreak has been linked with serious neurological disorders and lifethreatening birth defects. As the Member of Congress representing the Eighteenth Congressional District of Texas. centered in Houston. along the mainland United States Gulf Coast. I know first hand that Texans in particular are among the nations most atrisk. On March 10. 2015. I held a summit in Houston for the leading state and local experts in health. environmental control. and mosquito eradicating fields who are challenged with protecting communities from the Zika Virus to strategize and develop an action plan for the City and Harris County. Texas to reduce and control virus transmissions. Houston and other cities in the Gulf Coast region. during the late spring and summer months. have tropical climates that support the breeding habitats of Zika Virus carryingmosquitoes. In early March of this year. the Center for Disease Control and Prevention (CDC) reported 153 laboratoryconfirmed cases of the Zika virus infection. among U.S. travelers between December 2015 and March 9. 2016today. the number of reported cases has grown to 346. many of which are in areas further north than the 12 originally expected vulnerable states. The first confirmed cases of the Zika virus hit Houston in November of 2015. after the Harris County Public Health & Environmental Services (HCPHES) received confirmation from the CDC that the Zika virus was confirmed in a traveler recently returning from Latin America. Not long after. in January 15. 2016. the Centers for Disease Control issued a health advisory. On January 26. 2016. President Obama called for the rapid development of tests. vaccines and treatments to fight the mosquitotransmitted virus and insisted upon the need to develop vaccines and therapeutics. We have known of the potential enormity of the Zika threat since January 28. 2016. when the World Health Organization (WHO) reported that it was "spreading explosively" throughout the Americas and was likely to reach North America soon. As of January 28. 2016. the American Congress of Obstetricians and Gynecologists (ACOG) and the Society for MaternalFetal Medicine (SMFM) promulgated Practice Advisory guidance regarding the Zika virus and pregnant women. On February 1. 2016. the WHO announced an international public health emergency due to the recent cluster of neurological disorders and neonatal malformations reported throughout the Americas. On February 3. 2016. the first local transmission of a Zika virus infection was reported in the Caribbean. meaning that mosquitoes in the area were infected and began spreading the disease to people. Additionally. the Pan American Health Organization reported 26 countries and territories in the Americas exhibiting local transmission. On February 4. 2016. the CDC reported a case in Texas. my home state. of Zikas spread by sexual transmission. The Zika virus is primarily transmitted via three types of mosquitoestwo of which are rampant in the Houston area. The poor are an especially vulnerable population. living in a hot environment. The Gulf Coast presents unique vulnerabilities impacting the spread of the Zika virus in Houston that are of the utmost concern. and a key motivation for supporting todays legislation. My foremost priority is to protect the health and safety of Americans. especially those in Houston. My citys people and their surrounding neighbors are living daily in extreme povertyand now have to contend with this devastating disease. We saw in Brazil that the poorest communities of their nation experienced the worse Zikaplagued outcomes. Environmental issues. such as discarded tires. furniture. and debris are part of the landscape of the Americans lives we ought to be safeguardingand are creating the perfect breeding conditions for Zika mosquitoes. Amplifying the impact. the CDC reports that the virus is spread through sexual contact and advises special precautions for pregnant women. The Zika virus can be spread from a pregnant woman to her fetus and has been linked to a serious birth defect of the brain called microcephaly in the babies of mothers who were exposed to the Zika virus while pregnant. Exacerbating measures. expectant mothers may not know that Zika virus mosquitoes inhabit the areas in which they live. until they see the terrible birth defects associated with the disease. plaguing the lateterm30week ultrasound images of their unborn childs sonogram. Other problems have been detected among fetuses and infants infected with Zika virus before birth. such as absent or poorly developed brain structures. eye defects. hearing deficits. and impaired growth. About one in five people infected with the Zika virus become symptomatic. Characteristic clinical findings include acute onset of fever. maculopapular rash. arthralgia. or conjunctivitis. Today we are witnessing the spread of yet another tropical disease. threatening the health of U.S. citizens. much like Ebola did during the past few years. The WHO confirmed that as many as four million people could be infected by the end of the year. There is no treatment or cure for those infected by the Zika virus. The WHO is concerned about this rapidly spreading disease due to the lack of immunity in newly affected areas. the wide geographical distribution of infected mosquitos. and the absence of any vaccines. treatments. or rapid diagnostic tests. Given the lack of treatment available for the Zika virus. many supported the critical need for the FDA to use its Congressionally granted authority to add Zika to the list of Neglected Tropical Diseases eligible for the Priority Review Voucher program. On February 22. 2016. President Obama asked Congress to consider an FY 2016 emergency supplemental appropriations request of approximately $1.9 billion to respond to the Zika virus. both domestically and internationally. In conjunction with todays bills efforts. this funding would build upon ongoing preparation efforts and provide resources for the Departments of Health and Human Services and State. as well as the U.S. Agency for International Development (USAID). The collective goal of these efforts. as I see them. is to provide immediate responsiveness to prepare for and prevent the spread of Zika virus transmission. Speed research. development. and procurement of vaccines. therapeutics. and diagnostics. and Enhance the ability of Zikaaffected countries to better combat mosquitoes. control transmission. and support affected populations. The necessity presents itself to fortify our domestic health system. detect and respond to any potential Zika outbreaks at home. and to limit the spread in other countries. S. 2512 encourages the Federal Government to take a needed step. addressing the changing circumstances and emerging needs of populations exposed to the Zika virus. The CDC and NIH said that the previously endemic Ebola Virus created a template for Federal and State agencies that are currently attempting to address the Zika virus threat. If nothing else. the Ebola crisis demonstrated the critical need to develop effective vaccines and treatments before an endemic outbreak begins. This simple action by the FDA. I hope. will spur the development of an effective vaccine or treatment combating the Zika virus. and as a result save countless American lives. This bill is a step toward providing the protections that should be guaranteed to every American. I urge my colleagues to join me in supporting S.2512. the Adding Zika Virus to the FDA Priority Review Voucher Program Act.