Originally Published IVD Technology
June 2004
EDITOR'S PAGE
Working together on biodefense
The Bush administration’s recent attempt to boost the nation’s biodefense efforts demonstrates its myopia about the need for biodefense diagnostics (see News, p. 12).
Effective biodefense diagnostics should be considered a critically important element in the fight against bioterrorism, enabling first responders to determine whether a bioterrorist pathogen has been released and to identify that pathogen. Unfortunately, this simple concept seems to have escaped administration officials.
In their efforts to develop biodefense diagnostics, IVD manufacturers have encountered obstacles on a variety of fronts. On the regulatory front, for example, FDA has classified tests for detecting bioterrorist pathogens such as anthrax as Class III devices, requiring manufacturers to go through the lengthy and rigorous premarket approval (PMA) process instead of the speedier premarket notification (510(k)) process.
According to AdvaMed (Washington, DC), IVD manufacturers have also encountered difficulties in obtaining samples for validating their biodefense tests.
The Centers for Disease Control and Prevention (CDC; Atlanta) have been willing to provide some samples. However, manufacturers have found CDC’s conditions and requirements for providing such samples to be restrictive and burdensome.
In addition, the government maintains such tight control over the market for biodefense diagnostics that many IVD manufacturers have been discouraged from developing such tests.
“Only those tests that are validated by a relevant government agency, such as CDC or the Department of Agriculture, may be used for biodefense diagnostic purposes,” says Rick Naples, vice president for regulatory submissions, reimbursement, and government affairs at Roche Diagnostics (Indianapolis) and chairman of the working group on technology development and regulation for AdvaMed’s Medical Technology Preparedness Council. “However, the government agency often chooses to develop and validate its own in-house tests, rather than evaluating diagnostic products from IVD manufacturers.”
Fostering a strong partnership between the public and private sectors is the surest way to expedite the development and approval of biodefense diagnostics. Toward this end, according to AdvaMed, administration officials should take the following actions:
• Require interagency cooperation to avoid duplicating oversight and to expedite approval of biodefense diagnostics. Ideally, approval should be the responsibility of a single agency.
• Encourage CDC to provide access to validation samples.
• Include IVD manufacturers on key advisory panels, such as the Secretary’s Council on Public Health Preparedness and the National Science Advisory Board for Biosecurity.
• Hold regular workshops with device industry groups.
The IVD industry has already demonstrated its willingness to partner with government agencies in order to meet the challenges related to biodefense. Now it is the administration’s turn to show that it can implement President Bush’s biodefense directive in a fashion that streamlines existing programs and avoids adding layers of complexity or duplicating oversight.
Richard Park
Copyright ©2004 IVD Technology
