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house Bill H.R. 4400

Should the FDA Incentivize Companies to Find a Treatment for the Zika Virus?

Argument in favor

Zika virus is a global public health emergency that has already reached Texas and Florida. Congress should use the voucher program to speed up research into a treatment and protect the U.S. from an outbreak.

DonaldTrump's Opinion
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02/08/2016
"You gotta do everything you can... What you have to do is test off...which is basically spraying... but I don't think that will be very effective." [Hugh Hewitt Show]
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Steven's Opinion
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02/05/2016
Incentivize???? What a nice word for bribe, should we have to bribe medical companies into finding a cure for a disease? This is a classic illustration of why the free market economy and medicine don't mix. Finding cures for diseases and treating the sick and injured should not be profit driven. Because now medical companies need to be bribed to do what they should be setting out to do with or without monetary gain. The free market economy needs to be removed from medicine, period! But for now since thats just my wishful thinking , go ahead and bribe them!
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beesandbooks's Opinion
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02/03/2016
Viruses do not respect borders. We need to work together in an international coalition to find treatments and vaccines for this global health threat.
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Argument opposed

The voucher system may be flawed, and can slow down the FDA’s review of other drugs. The program is not yet proven to be effective: Only three tropical disease vouchers have been awarded since 2007.

Mythoughts's Opinion
···
02/03/2016
Before spending more money we should look at the cure proclaimed by the UK
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operaman's Opinion
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02/05/2016
Most private companies seeks public money to finance their "for profit" product. If there is a market for a new effective vaccine then there will be a big pharma company looking for a profit. When the Government throws tax payers cash into private enterprise you get problems like Solyndra. So Mr. Federal Government, keep my money at the IRS and I will purchase Big Pharmaceutical Stocks myself.
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Buddy brett's Opinion
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02/03/2016
Let the free market be free. Plus the FDA can't be trusted and this sounds like the first step toward mandatory vaccination. The link between Zika and both defects is still being investigated.
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What is House Bill H.R. 4400?

This bill seeks to add Zika virus to a list of diseases included in the Tropical Disease Priority Review Voucher Program, operated by the Food and Drug Administration (FDA). This program offers incentives and speeds up the review process for medications that treat "neglected diseases" prevalent in the developing world.

Zika has affected more than one million people in Brazil and spread to at least 30 countries and territories. The virus is passed to humans by mosquitoes, although the Centers for Disease Control and Prevention (CDC) confirmed the first known sexually transmitted case in Dallas, TX on February 2, 2016. Florida has also confirmed 9 cases of Zika and consequently issued a state of emergency. 

Zika can cause fever, rash, joint pain, and red eyes, although most infected people display no symptoms.

There are currently no vaccines or treatments to prevent or cure Zika. Rep. Butterfield’s bill would make it easier for the FDA to reward companies that develop vaccines or treatments for the virus, using the Priority Review Voucher Program, which was created by Congress as part of the 2007 FDA Amendments Act.

Under the voucher program, a company that develops an FDA-approved treatment for a neglected tropical disease is eligible to receive a special voucher that can be redeemed for a fast-tracked FDA review of another product in the future. The company may use the voucher itself, or sell it to another development company for up to hundreds of millions of dollars. Products undergoing this fast-tracked review are usually approved or denied within six months (as opposed to the standard review process, which averages more than a year).

The neglected disease voucher program currently lists 21 qualifying diseases like tuberculosis, malaria, cholera, dengue fever, and leprosy. Congress added Ebola to the qualifying list in December 2014. Vouchers may also be awarded for the development of a medication for any other infectious disease that primarily affects poor and marginalized populations.

Impact

People who have contracted Zika virus, people living in affected or at-risk areas, fertile women in affected areas who could get pregnant, companies that develop pharmaceuticals, and the FDA.

Cost of House Bill H.R. 4400

A CBO cost estimate is unavailable.

More Information

In Depth: The neglected diseases voucher program has its critics. Companies can be awarded vouchers for simply licensing drugs in the U.S. that were already approved and in use elsewhere, which doesn't foster new development. Additionally, a company does not have to make a newly approved neglected disease drug affordable in order to earn a voucher from it.  

Organizations like the Drugs for Neglected Diseases Initiative and Doctors Without Borders have lobbied the Senate Committee on Health, Education, Labor and Pensions to amend the program.


Of Note: Zika virus was first identified in monkeys in Uganda in 1947, but there were only 14 known cases in humans until 2007. There were then several outbreaks in the Pacific Islands before Zika reached Brazil in May 2015. Within a year, Brazil had more than one million cases.

Zika is particularly dangerous for pregnant women. It is linked to a steep increase in the number of Brazilian babies born with microcephaly, a birth defect causing small heads and underdeveloped brains. Babies whose mothers were infected with Zika during the first trimester may exhibit severe brain damage. On February 2, 2016, Brazil reported that it is investigating 3,670 suspected cases of microcephaly.

On February 1, 2016, the World Health Organization declared Zika a global public health emergency.

One of the scary parts of the virus is how little we know, including even the number of cases and degree to which it has spread. It has been linked to a few cases of a rare paralysis disorder called Guillain-Barre syndrome.  On February 2, 2016, experts were surprised by the first confirmed case of the virus spreading directly from person to person through sexual contact (instead of via mosquito) in Dallas, TX. Some governments are recommending delaying pregnancy until a treatment or vaccine is created.

Brazil, which has been hit the hardest by Zika, is set to host the 2016 Olympics this summer.


Media:

(Photo Credit: France Bleu)

AKA

Adding Zika Virus to the FDA Priority Review Voucher Program Act

Official Title

To expand the tropical disease product priority review voucher program to encourage treatments for Zika virus.

bill Progress


  • Not enacted
    The President has not signed this bill
  • The senate has not voted
  • The house has not voted
      house Committees
      Committee on Energy and Commerce
      Health
    IntroducedFebruary 1st, 2016
    "You gotta do everything you can... What you have to do is test off...which is basically spraying... but I don't think that will be very effective." [Hugh Hewitt Show]
    Like (51)
    Follow
    Share
    Incentivize???? What a nice word for bribe, should we have to bribe medical companies into finding a cure for a disease? This is a classic illustration of why the free market economy and medicine don't mix. Finding cures for diseases and treating the sick and injured should not be profit driven. Because now medical companies need to be bribed to do what they should be setting out to do with or without monetary gain. The free market economy needs to be removed from medicine, period! But for now since thats just my wishful thinking , go ahead and bribe them!
    Like (11)
    Follow
    Share
    Viruses do not respect borders. We need to work together in an international coalition to find treatments and vaccines for this global health threat.
    Like (9)
    Follow
    Share
    Most private companies seeks public money to finance their "for profit" product. If there is a market for a new effective vaccine then there will be a big pharma company looking for a profit. When the Government throws tax payers cash into private enterprise you get problems like Solyndra. So Mr. Federal Government, keep my money at the IRS and I will purchase Big Pharmaceutical Stocks myself.
    Like (4)
    Follow
    Share
    Let the free market be free. Plus the FDA can't be trusted and this sounds like the first step toward mandatory vaccination. The link between Zika and both defects is still being investigated.
    Like (4)
    Follow
    Share
    Before spending more money we should look at the cure proclaimed by the UK
    Like (4)
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    Health is an obvious policy for both sides of the aisle to rally behind
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    No
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    That is what the cdc is for. We definitely don't need anymore
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    If they have a cure they'll use it. This would be a big moneymaker for them; why would we incentivize something already very lucrative at the expensive of the taxpayer.
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    The FDA shouldn't be subsidizing stuff. I could see it easily biasing the approval process.
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    The incentive to create effective drugs for emerging medical problems already exists. It's called profit.
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    YES,THEY SHOULD,WE WILL ALL BENEFIT FROM THAT!!
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    There's no reason to waste our already dwindling budget on finding a cure or treatment for a virus that already has treatment options bidding in many other industrialized nations. Find a cure, but with our own forum rather than ask America's pharmaceutical companies who have already proven a number of times that they are not to be trusted with their financial decisions - especially a drug with such monopolizing power.
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    Preventing a Zika outbreak is an urgent issue
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    "Incentivize" usually means giving subsidies (our tax dollars) to private businesses. Government usually fails to pick the right winners and right losers.
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    we need to spend less money not more
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    The goal of companies is to make their owners a profit. What better way then to find the cure for such a problem as this virus. Let economic greed work to further advancement on this cure.
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    The free market will figure it out without government help.
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    Yes only if a plan speed research , without corruption
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