[Congressional Record (Bound Edition), Volume 162 (2016), Part 3]
[House]
[Pages 4047-4051]
[From the U.S. Government Publishing Office, www.gpo.gov]




    ADDING ZIKA VIRUS TO THE FDA PRIORITY REVIEW VOUCHER PROGRAM ACT

  Mrs. BROOKS of Indiana. Mr. Speaker, I move to suspend the rules and 
pass the bill (S. 2512) to expand the tropical disease product priority 
review voucher program to encourage treatments for Zika virus.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                                S. 2512

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Adding Zika Virus to the FDA 
     Priority Review Voucher Program Act''.

     SEC. 2. EXPANDING TROPICAL DISEASE PRODUCT PRIORITY REVIEW 
                   VOUCHER PROGRAM TO ENCOURAGE TREATMENTS FOR 
                   ZIKA VIRUS DISEASE.

       Section 524(a)(3) of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 360n(a)(3)) is amended--
       (1) by redesignating subparagraph (R) as subparagraph (S);
       (2) in subparagraph (Q), by striking ``Filoviruses'' and 
     inserting ``Filovirus Diseases''; and
       (3) by inserting after subparagraph (Q) the following:
       ``(R) Zika Virus Disease.''.

  The SPEAKER pro tempore. Pursuant to the rule, the gentlewoman from 
Indiana (Mrs. Brooks) and the gentleman from Texas (Mr. Gene Green) 
each will control 20 minutes.
  The Chair recognizes the gentlewoman from Indiana.


                             General Leave

  Mrs. BROOKS of Indiana. 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.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentlewoman from Indiana?
  There was no objection.
  Mrs. BROOKS of Indiana. Mr. Speaker, I yield myself such time as I 
may consume.
  Mr. Speaker, I rise today in support of S. 2512, which would add the 
Zika virus to the FDA Priority Review Voucher program.
  S. 2512 is companion legislation to H.R. 4400, authored by 
Representative Butterfield and myself.
  Under the FDA Priority Review Voucher program, once a vaccine or 
therapy for a disease on the FDA Priority Review Voucher program has 
been developed, the manufacturer of that product receives a voucher 
that can be used to fast-track review by the FDA of another product in 
the development pipeline. At zero cost to the taxpayer, this is a 
significant incentive for private industry to invest the hundreds of 
millions of dollars and the many man-hours it takes to produce a 
vaccine or treatment.
  In a world where we can travel across oceans in a matter of hours, an 
outbreak that begins on a different continent can arrive in the United 
States in a very short period of time. As Americans travel to and from 
Central and South America, we are beginning to see more Zika cases here 
at home.
  This doesn't just affect citizens in tropical areas, but in places as 
far north as Indiana as well. In my district, a nurse educator at 
Indiana Wesleyan University contracted the disease in January when she 
traveled to Haiti to teach a seminar in transcultural nursing.

[[Page 4048]]

  Most people don't experience symptoms if they contract the Zika 
virus, but women who become pregnant or trying to become pregnant and 
their babies are at risk. For babies, that can include serious birth 
defects that may lead to mental and physical disabilities. The threat 
is multi-generational, and we still don't know a lot about this 
disease. We can't treat it right now and we can't prevent it right now. 
That is a huge problem.
  The Zika virus is not the only biological threat we face to our 
public health and national security. Right now, despite the steps taken 
during and after the Ebola epidemic, we remain largely reactionary in 
our response to pandemics and biological threats. We need to be more 
proactive in our response to all pathogens, like the Zika virus, that 
are a threat to our national security and the health of our citizens.
  A more proactive approach would be to incentivize the development of 
vaccines and treatments through the FDA Priority Review Voucher 
program, known as PRV, before they reach the advanced stage of 
contagion.
  This past October, a bipartisan Blue Ribbon Panel on Biodefense 
released a report on America's vulnerabilities to a biological event. 
The panel found that the underlying problem isn't a specific disease, 
but our country's inability to mobilize quickly and effectively to 
identify, contain, treat, and eliminate any kind of biological threat 
to people in the United States.
  Incentivizing the research into a neglected tropical disease like 
Zika is a necessary, but not final, step. Our work is not done. As we 
move forward, we need to expand the PRV program to other items on the 
Department of Homeland Security's Material Threat list. Doing so will 
put us on offense and better prepare us for the next outbreak, whatever 
it might be.
  Today we have an opportunity to take meaningful action in a fight 
against this deadly disease. I applaud Speaker Ryan and Leader McCarthy 
for recognizing the severity of the threat and allowing for this bill's 
timely consideration.
  I have welcomed the opportunity to have worked with Representative 
Butterfield on this important issue, and Chairman Green and others on 
the Energy and Commerce Committee who recognize that the Zika virus is 
of significant threat not only to people in other parts of the world, 
but actually the people in the United States.
  Mr. Speaker, I reserve the balance of my time.
  Mr. GENE GREEN of Texas. Mr. Speaker, I yield myself such time as I 
may consume.
  Mr. Speaker, I rise to speak on S. 2512, the Adding Zika Virus to the 
FDA Priority Review Voucher Program Act.
  Representatives G. K. Butterfield and Susan Brooks led this 
legislation in the House and members of our Energy and Commerce 
Committee. I want to thank them for their commitment to mitigating the 
Zika virus outbreak.
  S. 2512 will add Zika virus to the list of qualified tropical 
diseases under the Tropical Disease Priority Review Voucher program, 
PRV.
  Zika virus is among several recent and emerging global health threats 
that remind us of the need for effective incentives for research and 
development of neglected tropical diseases, and for infectious diseases 
at large. Neglected tropical diseases, or NTDs, represent more than 10 
percent of the global disease burden. However, only 4 percent of all 
new drugs and vaccines approved across the globe in the next decade 
were for NTDs.
  The NTD Priority Review Voucher program was created by Congress in 
2007 to be a much-needed incentive for products that diagnose and treat 
such diseases for which market forces fall short.
  The Adding Ebola to the FDA Priority Review Voucher Program, which 
was signed into law in 2014 and was led by myself and Representative 
Marsha Blackburn, gave the FDA the authority to add diseases to the 
program by issuing an order. The agency has already used this authority 
to add Chagas to the program. While the program is successful, it could 
be more so.
  Currently, there is no requirement for a product to be novel or that 
it be made available and affordable for the patients whom awarded 
products are designed to help. It should be amended to strengthen its 
effectiveness. This can be done by adding a novelty requirement and an 
access strategy requirement, like what is mandated under the Rare 
Pediatric Disease Priority Review Voucher program.
  This legislation did not go through the House Energy and Commerce 
Committee, so the opportunity to discuss the NTD PRV program was not 
taken. I hope to work with my colleagues to incorporate amendments on 
future legislation that will improve the functioning of the program. 
Doing so will allow it to incentivize novel programs and ensure they 
are widely accessible to patients in need.
  Improvements to the PRV program would be one important step toward 
ensuring we have effective strategies to incentivize both research and 
development for NTDs. Broader changes are urgently needed to ensure the 
R&D system delivers new vaccines, diagnostics, and treatments to 
patients presenting and exposed to NTDs and resistant infections.
  I look forward to working with my colleagues on additional mechanisms 
to ensure R&D for these emerging threats is successfully and properly 
incentivized. Doing so is necessary for the flourishment of biomedical 
innovation in this space.
  I fully agree with the bill sponsors that we need to do all we can to 
respond to the Zika virus by facilitating the development of and access 
to medical products as quickly as possible.
  The administration has asked Congress for $1.9 billion in emergency 
funding to enhance our efforts to prepare and respond to the outbreak, 
both around the world and here at home.
  This legislation is arguably a step in the right direction, and I 
again thank the sponsors for their commitment and leadership. However, 
this bill far from renders the emergency supplemental funding request 
unnecessary. Dedicated funds, some of which will go towards medical 
product development to respond to the Zika virus, are essential to 
sustaining Health and Human Services' response efforts.
  I urge my colleagues to ask swiftly to approve emergency funding for 
a robust Zika virus outbreak response.
  Mr. Speaker, I reserve the balance of my time.
  Mrs. BROOKS of Indiana. Mr. Speaker, I reserve the balance of my 
time.
  Mr. GENE GREEN of Texas. Mr. Speaker, I yield such time as he may 
consume to the gentleman from North Carolina (Mr. Butterfield), the 
cosponsor of the legislation, but also a member of our Energy and 
Commerce Committee.
  Mr. BUTTERFIELD. Mr. Speaker, I thank Congressman Green for yielding 
time, and thank him for his extraordinary leadership not only on this 
bill, but on our committee as well. To my colleague Susan Brooks from 
Indiana, I thank the Congresswoman for all of her work.
  Mr. Speaker, I rise today in support of adding the Zika virus to the 
FDA Tropical Disease Product Priority Review Voucher program. The bill 
we are considering today is the Senate companion to my bill, H.R. 4400, 
which I introduced on February 1 of this year.
  Yesterday the White House and the CDC announced the dangers of the 
Zika virus are ``scarier than we initially thought.'' The CDC estimates 
that there are already hundreds of thousands of cases in the United 
States and that the number is expected to grow as the summer nears.
  The health consequences of the Zika virus infection are staggering. 
Zika infections in pregnant women can result in serious birth defects, 
including microcephaly and neurological disorders in newborns. The 
virus also has serious impacts on adults. This is a global public 
health emergency. We must act now to combat the spread of this deadly 
virus.
  My bipartisan legislation, cosponsored by 31 of our House colleagues, 
and the Senate companion cosponsored by 11 Senators, provides a pathway 
for expediting treatments for Zika.
  Supporting research and development in the U.S. to fight this will 
not only

[[Page 4049]]

benefit us here at home, but will also help hundreds of millions of 
people around the world.
  Mr. Speaker, I urge my colleagues today to support this legislation 
and other efforts, including authorizing additional emergency funding 
to combat this virus.
  Mrs. BROOKS of Indiana. Mr. Speaker, I would also like to thank the 
gentleman from North Carolina (Mr. Butterfield) for his leadership on 
this issue and for certainly bringing this to our attention as soon as 
it was brought to his attention that this needed to be resolved.
  I yield 2 minutes to the gentleman from Georgia (Mr. Carter).
  Mr. CARTER of Georgia. Mr. Speaker, I thank the gentlewoman for 
yielding.
  Mr. Speaker, I rise today in support of S. 2512 to add the Zika virus 
to the list of tropical diseases under the FDA Priority Review Voucher 
program for tropical diseases.
  While evidence of human infection by the Zika virus has been reported 
for over 60 years, there has been little progress in the development of 
treatment or vaccines. Existing incentives have been insufficient to 
encourage development of new and innovative treatments for the virus.
  However, with the recent spread of the virus from South America to 
the Caribbean and North America, the level of infection has reached 
pandemic levels. Although the Zika virus may be rare in the United 
States, the increase of airline transportation, immigration, and 
tourism only creates an environment for the Zika virus to be easily 
transmitted.
  S. 2512 would allow the FDA Priority Review Voucher program to work 
exactly as intended. It would add the Zika virus to the list of 
tropical diseases that are available under the voucher program.
  This bill would ultimately accomplish two goals. First, it would 
provide an incentive for drug developers in the form of fast-track 
approval of therapies to treat the Zika virus.
  Second, it would create an avenue where treatments for the virus 
would get to patients quicker and ultimately end this pandemic 
outbreak.
  This legislation is vital to ensuring the health and safety of our 
Nation. I encourage my colleagues to support this legislation.
  Mr. GENE GREEN of Texas. Mr. Speaker, we have no other speakers.
  I yield back the balance of my time.
  Mrs. BROOKS of Indiana. Mr. Speaker, I yield myself such time as I 
may consume.
  I would just like to point out that as recently as yesterday, Federal 
officials have indicated that the mosquito that carries the Zika virus 
is actually anticipated to be in over 30 States at this point. 
Originally, it was in 12 States, and now it is believed to be found in 
30 States in the United States.
  This is an extremely serious problem, one in which I am pleased that 
this House and this Chamber is paying attention to. I appreciate the 
gentleman from Georgia and his remarks.
  I yield back the balance of my time.
  Ms. JACKSON LEE. 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 life-threatening 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 nation's most at-risk.
  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 carrying-mosquitoes.
  In early March of this year, the Centers for Disease Control and 
Prevention (CDC) reported 153 laboratory-confirmed cases of the Zika 
virus infection, among U.S. travelers between December 2015 and March 
9, 2016--today, 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, on 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 mosquito-transmitted 
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 Maternal-Fetal 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 Zika's spread by sexual transmission.
  The Zika virus is primarily transmitted via three types of 
mosquitoes--two 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 today's legislation.
  My foremost priority is to protect the health and safety of 
Americans, especially those in Houston.
  My city's people and their surrounding neighbors are living daily in 
extreme poverty--and now have to contend with this devastating disease.
  We saw in Brazil that the poorest communities of their nation 
experienced the worse Zika-plagued outcomes.
  Environmental issues, such as discarded tires, furniture, and debris 
are part of the landscape of the Americans' lives we ought to be 
safeguarding--and 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 late-
term-30-week

[[Page 4050]]

ultrasound images of their unborn child's 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 today's bill's 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 Zika-affected 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.
  Mr. PALLONE. Mr. Speaker, I rise today in opposition to S. 2512, 
which would add Zika to the list of qualified tropical diseases under 
the Food and Drug Administration's Tropical Disease Priority Review 
Voucher Program. While I know that we would all agree that there is 
desperate need for a treatment for Zika, I do not believe that this 
legislation offers the solution that will help us to achieve that goal. 
Further, I am disappointed that this legislation has not had the 
benefit of any legislative action in our Committee where Members could 
discuss in greater detail the need for reforms to the currently flawed 
priority review voucher program.
  In 2007, Congress established the Tropical Disease Priority Review 
Voucher Program at FDA to incentivize treatments for neglected tropical 
diseases for which there was no market incentives to develop. Sponsors 
that develop a treatment for a qualified tropical disease are awarded a 
priority review voucher and have the option of retaining this voucher 
for a shortened review of another product in their development 
pipeline, or can sell the voucher to another company to use. Since 
enactment, three vouchers have been awarded under this program, two of 
which sold for $67 million and $125 million respectively. The value of 
the vouchers to sponsors has led to the development of the priority 
review voucher as a financial incentive in other areas, such as rare 
pediatric diseases.
  However, this program is not without flaws. Use of priority review 
vouchers is not limited to additional tropical disease products, 
meaning that companies can use this voucher for a review in six months 
of any product of its choosing. This can result in new drug 
applications receiving priority review that would not otherwise qualify 
if they do not treat a serious disease or condition, or offer a 
significant improvement in safety or effectiveness. In practice, this 
allows companies to ``purchase'' services from the agency at the 
expense of other important public health work, undermining FDA's 
mission and the morale of the agency's review staff. It also creates 
additional workload for the FDA by requiring a shortened review of 
applications for treatments that will be used in millions of patients 
and diverting review staff from other work. Finally, the additional 
priority review voucher fee associated with use of the voucher has not 
been effective in covering the full cost of the expedited review.
  In addition to effects on FDA, the current tropical disease priority 
review voucher program contains two additional flaws--eligibility for 
this program is not limited to novel therapies, nor are sponsors 
required to make the qualifying therapy available or accessible for 
those who are most in need. Two of the three priority review vouchers 
awarded under this program were awarded to therapies that were already 
in use in other countries prior to the program's establishment. Thus a 
voucher was awarded to sponsors without any new investment in tropical 
disease treatments. Similarly, patients and other organizations still 
struggle to access two of the three therapies awarded a priority review 
voucher either due to affordability or lack of availability. An award 
such as a priority review voucher should only be given to companies who 
are committed to making their therapy available to patients in disease-
endemic countries for which the program is intended to help.
  As we consider the bill before us today, it is important to note that 
FDA has the authority to add Zika to the tropical diseases program 
administratively if there is no significant market in developed nations 
for that disease and the disease disproportionately affects poor and 
marginalized populations. I will submit a letter from FDA noting that 
it is ``extremely unlikely that the Zika virus meets the criteria set 
out in the statute'' as there is a significant market for medical 
products for Zika virus currently. According to the agency, expanding 
the program to include Zika, which would be ineligible, would weaken 
the effectiveness of the priority review program and would create an 
undue burden on FDA.
  Mr. Speaker, it is for all of these reasons that I am opposing S. 
2512 today. It is clear there are significant issues with the tropical 
disease priority review voucher program that should have been discussed 
and considered as a part of the Committee process. Unfortunately, we 
were not afforded that opportunity. If the goal of the House is to 
address the Zika crisis, we should not be expanding a flawed program 
that will provide incentives for which there is no need. Instead 
Congress should be working together, including with the Administration, 
to fully fund a comprehensive response to Zika. I submit the following 
letter:

         Department of Health & Human Services, Food and Drug 
           Administration,
                             Silver Spring, MD, February 29, 2016.
       Dear Member: Thank you for your letter of February 05, 
     2016, urging the Food and Drug Administration (FDA or the 
     Agency) to add Zika virus to the list of qualified tropical 
     diseases under the Tropical Disease Priority Review Voucher 
     (PRV) Program by issuing an order, as authorized by the 
     Adding Ebola to the FDA Priority Review Program Act [PL 113-
     233].
       FDA is actively working on many fronts to help mitigate the 
     Zika virus outbreak. The Agency's primary areas of activity 
     include:
       (1) protecting the safety of the nation's blood supply and 
     ensuring the safety of cell and tissue products;
       (2) facilitating the development and availability of blood 
     donor screening and medical diagnostic tests for 
     identification of the presence of, or prior exposure to, Zika 
     virus;
       (3) supporting the development of investigational vaccines 
     and therapeutics;
       (4) reviewing proposals for the use of innovative 
     strategies to help suppress the population of virus-carrying 
     mosquitoes;
       (5) protecting the public from fraudulent products that 
     claim to prevent, diagnose, treat, or cure Zika virus 
     disease.
       Specific activities include issuing guidance to blood 
     collection centers on safeguards to prevent transfusion 
     transmission of Zika virus in areas of the U.S. and its 
     territories with active mosquito borne transmission 
     (currently Puerto Rico, U.S. Virgin Islands, American Samoa 
     and Marshall Islands), and in unaffected areas where the 
     virus might be introduced by persons returning from affected 
     areas. FDA is also developing guidance that will address 
     appropriate donor

[[Page 4051]]

     screening for human cells, tissues, and cellular and tissue-
     based products: concerns in this area have been highlighted 
     by reported possible sexual transmission of the Zika virus. 
     FDA is reaching out to potential commercial product 
     manufacturers to encourage them to develop and submit 
     applications for emergency use of diagnostic tests for the 
     Zika virus. In addition, FDA is actively engaged with the 
     Office of the Assistant Secretary for Preparedness and 
     Response (ASPR), the Biomedical Advanced Research and 
     Development Authority (BARDA), the National Institutes of 
     Health (NIH), and the Centers for Disease Control and 
     Prevention (CDC) to advance the development of diagnostic 
     tests, vaccines, therapeutics, and donor screening and 
     pathogen-reduction technologies for blood products to help 
     mitigate this outbreak. These efforts have already realized a 
     major success. On February 26, 2016, under its Emergency Use 
     Authorization (EUA) authority, FDA authorized the use of a 
     Zika virus diagnostic test--developed by CDC--for the 
     qualitative detection of Zika virus-specific immunoglobulin M 
     (IgM) antibodies by qualified laboratories. This diagnostic 
     test can help expand domestic readiness for Zika virus by 
     enabling the identification of patients recently infected 
     with Zika virus in support of response efforts.
       As you are aware, under section 524 of the Federal Food, 
     Drug, and Cosmetic Act, the Secretary of Health and Human 
     Services is authorized to add infectious diseases to the list 
     of tropical diseases that would qualify the developer of a 
     licensed or approved product to prevent or treat an 
     identified tropical disease to receive a PRV under FDA's 
     Tropical Disease PRV Program, if: (1) there is no significant 
     market in developed nations for that disease; and (2) the 
     disease disproportionately affects poor and marginalized 
     populations. This authority is delegated to FDA.
       FDA has provided a process for requesting that additional 
     diseases be added to the PRV list through the submission of a 
     request to a special docket set up to facilitate the 
     consideration of such requests, accompanied by information to 
     document that the disease meets the statutory criteria 
     required to be added to the PRV list. While FDA has not 
     received a request to add the Zika virus to the PRV list via 
     the docket, the Agency does not want to foreclose anyone from 
     following that process and will evaluate any submissions that 
     are made with respect to the Zika virus. FDA wants to make it 
     clear, however, that--based on the information currently 
     available to FDA--it is extremely unlikely that the Zika 
     virus meets the criteria set out in the statute. While it 
     appears likely that the Zika virus disproportionately affects 
     poor and marginalized populations, it also appears that there 
     is a significant market for the Zika virus medical products 
     in developed nations, which would render the Zika virus 
     ineligible for addition to the PRV list under the statute at 
     this time.
       FDA agrees that we need to do all that we can to facilitate 
     the development of and access to medical products as quickly 
     as possible to respond to the Zika virus outbreak. We fully 
     believe that the incentives currently available for the Zika 
     product development--such as funding for research and 
     development, and clinical trial costs from government and 
     non-governmental organizations--as well as extensive HHS 
     technical assistance for product developers, are sufficient 
     to help bring Zika products to market. FDA is fully prepared 
     to use its authorities to the fullest extent appropriate--
     including proven mechanisms to speed the availability of 
     medical products for serious diseases--to help facilitate the 
     development and availability of products with the potential 
     to mitigate this outbreak as quickly as the science will 
     allow. However, expanding the PRV program by adding diseases 
     or conditions that do not meet the criteria for inclusion is 
     unnecessary, weakens the effectiveness of the PRV program, 
     and creates an undue burden on FDA that can ultimately harm 
     public health.
       As you are aware, the Administration has asked Congress for 
     approximately $1.9 billion in emergency funding to enhance 
     our ongoing efforts to prepare for and respond to the Zika 
     virus, both domestically and internationally. Approving this 
     funding request, which includes support for medical product 
     development and procurement, is essential for sustaining 
     HHS's effort to effectively incentivize the development and 
     availability of medical products for the Zika virus.
       Thank you, again, for contacting us concerning this matter. 
     If you have any questions or concerns, please do not hesitate 
     to contact me. The same letter has been sent to your 
     cosigners.
           Sincerely,

                                             Dayle Cristinzio,

                                 Acting Associate Commissioner for
                                                      Legislation.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentlewoman from Indiana (Mrs. Brooks) that the House suspend the rules 
and pass the bill, S. 2512.
  The question was taken; and (two-thirds being in the affirmative) the 
rules were suspended and the bill was passed.
  A motion to reconsider was laid on the table.

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