WASHINGTON, D.C. – Following a request from U.S. Sens. Sherrod Brown (D-OH) and Rob Portman (R-OH) on Friday, the Food and Drug Administration (FDA) has expedited approval of on-site rapid Ebola test technology for use in northeast Ohio hospitals.
“While we seek the best solutions to contain and prevent the spread of Ebola, it’s important that our response is not only rapid and effective but also nimble,” Brown said. “That’s why we asked the FDA to expedite the review process of this diagnostic equipment – to provide northeast Ohio’s world-class hospitals with the best tools to tackle this virus.”
“As northeast Ohio continues its Ebola response, it’s crucial that the federal government allow hospitals to utilize the best equipment possible to contain this disease and keep health care workers safe,” Portman stated. “That’s why we urged the FDA to expedite their review process and allow Ohio’s hospitals to obtain the state-of-the-art equipment they need to do their important work fighting Ebola.”
The U.S. Department of Defense (DOD) is utilizing a “rapid diagnostic” test in West Africa, but the technology had not yet been approved for commercial use by the FDA. In a letter to FDA Commissioner Margaret Hamburg, Brown and Portman asked that the FDA quickly and carefully review technologies such as this and allow for their use in communities potentially exposed to the virus. After receiving the letter, the FDA applied its emergency use authorization power to certify two such tests for emergency commercial use. This rapid diagnostic technology saves time because the blood sample can be read more quickly than a traditional test, and it does not require transport of the sample to an outside lab. One of the new tests is for hospitals and commercial labs and the other is for labs designated by DOD.
In addition, last week Brown called on Administration officials to take a more active role in helping state and local officials prepare for any potential Ebola threat in Ohio. In a letter to the Secretary of the U.S. Department of Health and Human Services (HHS) Sylvia Mathews Burwell, Centers for Disease Control and Prevention (CDC) Director Thomas Frieden, and Ebola Response Coordinator Ron Klain, Brown outlined a five-part plan for managing any emerging cases of Ebola. These include:
- Going above and beyond the CDC’s traditional role of providing guidance to local authorities to becoming an active partner in the local decision-making process;
- Meeting and working directly with state and local public health experts and health care providers on a consistent basis to continually assess, update, and enhance protocols;
- Monitoring closely the individuals who have been quarantined under local authority;
- Partnering with local health care systems and hospitals to develop a clear plan for any potential patients and educating all health care professionals on this plan of action; and
- Sending additional preparedness experts, infection control experts, and additional personnel from the CDC to Ohio.
Brown is working closely with federal, state, and local medical experts and health officials to monitor the situation and ensure potential threats are immediately identified and contained. When the threat first came to Ohio two weeks ago, Brown wrote to Burwell and Frieden asking HHS and the CDC to take action to monitor potential exposure in Northeast Ohio.
Full text of the Friday letter is below.
October 24, 2014
Margaret A. Hamburg, M.D.
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993-0002
Dear Commissioner Hamburg:
We are writing you out of concern about the presence of Ebola in the United States and its impact on communities in Northeast Ohio.
As you know, one of the healthcare workers who treated the deceased patient in Texas, and subsequently contracted Ebola, traveled to Northeast Ohio soon before her diagnosis. As a result, 163 Ohioans came into contact with this person, including three people who remain under quarantine.
Our constituents in northeast Ohio are fortunate to have access to world-class hospitals and medical professionals. However, despite the health care expertise in this region, none of the medical facilities have the capability to test onsite for the Ebola virus. Quick diagnosis is essential to ensure that limited resources are properly applied when a person is suspected of having the virus.
We understand the Department of Defense (DOD) is utilizing a rapid diagnostic test called FilmArray, which is manufactured by BioFire Diagnostics, in its mobile testing units deployed in the West African nations with the highest levels of Ebola transmission. Unfortunately, FDA has only approved FilmArray for “research-use only” in the U.S. and the device is not available for commercial use.
Given the threat of Ebola, and the close connection for many of our constituents, we ask that you carefully and quickly review whether a rapid test such as FilmArray and any other effective diagnostics are ready for an investigational device exemption under Section 520(g) of the Federal Food, Drug, and Cosmetic Act. It is critically important for innovations, such as this simple and cost-effective device, to be put to emergency use domestically in the communities that have been directly impacted by the virus.
I thank you in advance for your consideration of this time-sensitive matter.
Senator Sherrod Brown Senator Rob Portman