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Congressman Portman, Co-Chair Of The Speaker's Task Force For A Drug-Free America, Questions FDA Jurisdiction and Calls Upon the FDA to Not Regulate On-Site Tests
The Co-Chair of the House of Representatives Speaker's Task Force for a Drug-Free America sent letters to HHS Secretary Tommy Thompson and Dr. Bernard A. Schwetz, the acting Principal Deputy Commissioner of the Food and Drug Administration (FDA), questioning the FDA jurisdiction to regulate on-site drug testing and calling upon them to "consider the impact of drastic cost increases on employers before beginning regulation of on-site workplace tests."
David G. Evans, the Executive Director of the National On-site Testing Association (NOTA) provided background on the reason for the letter. "The FDA has recently notified the on-site manufacturers that it intends to require that each on-site test be priced to include up-front the cost of obtaining laboratory confirmation of the results of the test, even though confirmation is only needed for a small percentage of the tests (less than 5%). The FDA also seeks to require the tests to meet over the counter approval (OTC) so that someone with an 8th grade education can use them. These requirements would dramatically and unnecessarily increase the cost of testing. The OTC requirement alone will add manufacturing costs of between $50,000 to $200,000 for each test. Over the counter approval is not needed. The tests are easy to use and interpret and are performed by personnel trained by the test manufacturers. The U.S. Postal Service does hundreds of thousands of these tests per year. Law enforcement, military, and business use them without problems."
Evans also noted that: "Congressman Portman, as a co-chairman of Speaker Hastert's Task Force for a Drug-Free America and a recognized leader of drug prevention efforts in Congress, credibly makes the point that, as a matter of policy, workplace drug testing is a crucial workplace safety and prevention tool. His letter argues that if the FDA moves forward with enforcement, on-site workplace testing to ensure safe work environments will be threatened, disproportionately affecting small businesses. The Speaker's Task Force advocates a balanced, effective, and unified approach to U.S. drug policy, including proven effective drug-free workplace programs which increasingly rely on on-site workplace drug testing."
Laura Shelton, Executive Director of the Drug and Alcohol Testing Industry Association (DATIA) noted that: "Congressman Portman is a very influential member of Congress. He is the Co-Chair of the Speaker’s Task Force on a Drug-Free America and he is the Assistant Majority Whip. To have his support sends a powerful message to the FDA that their actions would severely disrupt the use of urgently needed on-site tests in employment and is counter to the national security interests of the United States."
For information contact David G. Evans at NOTA. Phone: 908-806-0008 or Laura Shelton at DATIA at: 703-548-0901.
THE LETTER FOLLOWS (the same letter was sent to Tommy Thompson):
November 14, 2001
Bernard A. Schwetz, D.V.M., Ph.D.
Acting Principal Deputy Commissioner
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857-0001
Dear Dr. Schwetz:
As a co-chair of the Speaker's Task Force for a Drug-Free America, I am writing to urge the FDA to reconsider its planned regulation of on-site workplace drug testing devices.
As you know, on-site workplace drug testing is the cornerstone of effective drug-free workplace programs used by tens of thousands of employers nationwide. Millions of on-site tests are performed every year with great success and prevent workplace accidents and drug use in general. I am concerned that enforcement of the draft guidance would cause unnecessary cost increases and undermine the ability of employers to ensure workplace safety through on-site testing.
The proposed "cost-bundling" regulation would significantly drive up the costs to employers administering the tests. It is not sensible to mandate the cost of confirmatory lab tests be included in the original cost of all on-site tests when less than five percent of the tests require confirmation. Building in this requirement would more than triple the cost of on-site tests and undercut the ability of employers, especially small businesses, to test their employees and ensure safe and drug-free workplaces.
In addition, I am told the FDA has no lawful jurisdiction over workplace drug testing devices unless the devices are intended for use in the diagnosis or treatment of disease. I am advised in vitro diagnostic devices regulated by the FDA are defined as "those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease." However, on-site workplace drug tests are not designed to cure, mitigate, treat, prevent, or diagnose any disease. Rather, they simply indicate recent use of illegal drugs by that person.
Therefore, in accordance with all applicable laws and regulations, I request the FDA reconsider its legal jurisdiction and consider the impact of drastic cost increases on employers before beginning regulation of on-site workplace tests. Please feel free to contact me if you have questions.
Sincerely,
Rob Portman
Representative
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