Bills
| 3.23.22

Does the FDA Need to Incentivize Companies to Research a Zika Virus Treatment? (S. 2512)

Do you support or oppose this bill?

What is S. 2512?

(Updated March 15, 2018)

This bill was enacted on April 19, 2016

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. Sen. Franken’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.

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.

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.

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 S. 2512

A CBO cost estimate is unavailable.

Additional Info

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: Flickr user Agencia Brasilia)