US Senate Unveils Major Changes to FDA Program in Hopes of Fighting Ebola

Regulatory NewsRegulatory News | 12 November 2014 |  By 

Legislators in the US Senate have unveiled a new piece of legislation meant to incentivize companies to go after the Ebola virus by making critical and long-sought changes to a US Food and Drug Administration (FDA) regulatory program.


As Focus explained in October 2014, a recent outbreak of Ebola has led to a scramble for new drugs and vaccines to help treat and prevent the virus. At present, there are no recognized treatments for the disease.

Some public health officials, including the World Health Organization's Margaret Chan, have criticized the pharmaceutical industry's lack of investment in investigational treatments for the disease, saying many companies had likely determined the return on any investment for an Ebola treatment was not worth the development cost.

In the US, a 2007 law known as the Food and Drug Administration Amendments Act (FDAAA) was meant to provide incentives for companies to invest in disease areas without a lucrative market. The so-called "Tropical Disease Priority Review Voucher" system is meant to give companies who successfully develop a drug for an otherwise neglected tropical disease a special "priority review voucher" capable of shaving four months off of FDA's standard 10-month review time.

For some drugs, such as potential blockbuster drugs, the potential to reach consumers four months faster could be worth tens—even hundreds—of millions of dollars. The vouchers can also be sold to other companies, and a similar voucher obtained under FDA's pediatric voucher program recently sold for more than $67 million.

Priority Voucher Requirements

But there's a problem: To date, FDA has designated just 16 diseases as eligible under the tropical disease priority review voucher system.

Eligible Diseases Under the Tropical Disease Priority Review Voucher System
MalariaBlinding trachoma
Buruli UlcerCholera
Dengue/Dengue haemorrhagic feverDracunculiasis (guinea-worm disease)
FascioliasisHuman African trypanosomiasis
Lymphatic filariasisOnchocerciasis
SchistosomiasisSoil transmitted helminthiasis

The Ebola virus, however, is not on FDA's list, meaning drugs developed to treat the virus would not be eligible for the priority review voucher.

At least some legislators now want to change that.

Add Ebola to the List?

As Focus reported last month, after one of the intellectual fathers of the priority review voucher program called for Ebola to be added to the list of eligible diseases, two of the Senate's most prominent healthcare legislators said they agreed and would soon introduce legislation to that effect.

In a statement, Sens. Tom Harkin (D-IA) and Lamar Alexander (R-TN) said they planned to introduce legislation that would "speed the development of treatments and vaccines for Ebola by adding Ebola to FDA's priority review 'voucher' program."

"When enacted, as I hope it will be, this legislation will strengthen our response to Ebola and help innovators to continue their work to develop Ebola treatments and vaccines. I urge my colleagues to join me in passing this bill and continuing to invest in the public health agencies on the frontlines of the U.S. response to Ebola," Harkin explained. Alexander noted that the world is in "desperate need of a vaccine" to treat the disease.

The plan, Focus noted, is not without its potential pitfalls. For example, the voucher program has not been particularly successful since it has several provisions which limit its usefulness. In addition, FDA technically already has the authority to add Ebola to its list of eligible diseases, but for whatever reason has not yet done so.

Legislation Unveiled and Moving Forward

Now the Senate has indicated it is moving forward with Harkin and Alexander's Ebola legislation. In a notice on the Health, Education, Labor and Pension Committee's website on 12 November 2014, the committee said it would consider the bill, "Adding Ebola to the FDA Priority Review Voucher Program Act," during a 19 November 2014 executive session of the committee.

The text of the legislation, provided to Regulatory Focus, makes several noteworthy changes to the priority review voucher system.

In a major development, the bill would allow companies to give FDA just 90 days advance notice prior to using a tropical priority review voucher. At present, the program requires companies to notify FDA of their plan to use a voucher a full year prior to filing an application under the program. In contrast, a related pediatric voucher program requires just 90 days' advance notice—a change that makes it much easier to use the vouchers.

Another hurdle for the program has been that the vouchers cannot be sold more than once. That has meant some companies are hesitant to purchase a voucher since they would then be required to use it.

Under the Senate bill, however, the statute would be altered to allow tropical vouchers to be sold and re-sold an unlimited number of times.

"There is no limit on the number of times a priority review voucher may be transferred before such voucher is used," the legislation states. At present, the voucher may only be transferred only one time.

Finally, the bill would also add a 17th category of eligible diseases to the tropical priority review voucher system: Filoviruses, which includes the family of Ebola viruses as well as the Marburg virus family and the Lloviu virus.

FDA would also be allowed to amend the list of eligible diseases under the program though orders—not regulation—in the future, making it substantially easier to respond to future crises.


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