The Chairman and Ranking Member of the House Government Reform Subcommittee on Drug Policy and Criminal Justice sent a letter today to Dr. Bernard A. Schwetz, the acting head of the FDA, informing him that the FDA's recent attempt to regulated non-medical use of on-site drug tests is out of the FDA's jurisdiction. The subcommittee has oversight over the FDA.
"This letter is unprecedented." states David G. Evans, Esq., the Executive Director of the National On-site Testing Association, "To have a bipartisan letter from a Congressional oversight committee be sent so quickly shows the depth of the objection to the FDA's attempt to impose unnecessary and unauthorized regulatory burdens for on-site drug tests. The FDA actions would severely disrupt the use of on-site tests when they are urgently needed to keep illegal drug users out of the workplace and the military. Unnecessary regulation is irresponsible and counter to the national security interests of the United States."
Evans stated that "Recently, the FDA notified the on-site manufacturers that it intends enforce its draft "guidance" requiring that each device 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 went on to note: "Our industry and the many businesses and security agencies that use on-site testing are very alarmed. They have been writing to the FDA and to Congress. They are being heard. We are especially grateful to the members of the Drug and Alcohol Testing Industry Association (DATIA). DATIA has been with us 100% and their Executive Director Laura Shelton has been working the Hill with us. They have done an outstanding job."
"We told the FDA they have no jurisdiction," said Evans "and we are very gratified that Congress agrees with us. The FDA will be hearing from others on the Hill and from other federal agencies. This is just the beginning. We will keep the pressure on!"
The National On-site Testing Association is an advocacy and resource center for on-site drug and alcohol testing. NOTA members are the consumers, manufacturers, and distributors of on-site drug and alcohol tests.
For information contact David G. Evans at NOTA. Phone: 908-806-0008
THE LETTER FOLLOWS
November 9, 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 Chairman and Ranking Member of the House Government Reform Subcommittee on Criminal Justice, Drug Policy and Human Resources, we are writing to strongly encourage the FDA to consider a moratorium on the planned enforcement of regulations on on-site workplace drug testing devices. We are very concerned that the proposed regulations would have a devastating impact on the ability of private and governmental employers throughout the United States to ensure that employees work in a secure, drug-free environment.
On-site workplace drug testing is a cornerstone of effective drug-free workplace programs used by tens of thousands of employers nationwide. Millions of on-site workplace drug tests are performed every year with great success in terms of test accuracy, preventing workplace accidents, and preventing drug use in general. On-site workplace drug testing is extremely important in today's environment of heightened security at vulnerable workplaces like post offices, water treatment facilities, food processing plants, and transportation facilities. Unnecessary regulation of easy-to-use, non-diagnostic onsite drug use indicators would inhibit the ability of security-sensitive employers to quickly and cost effectively test employees.
We are concerned that the FDA plans to regulate on-site workplace drug testing without the legal jurisdiction to do so. The FDA has no lawful jurisdiction over workplace drug testing unless the testing is intended to be used for the diagnosis or treatment of disease. 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 or its sequelae"
. 21 C.F.R. § 809.3. On-site workplace drug tests do not cure, mitigate, treat, prevent, or diagnose any disease, nor do they determine the state of health of the person being tested. Rather, they simply indicate recent use of illegal drugs by that person.
Further, in the 1990 Americans with Disabilities Act, Congress stated that "a test to determine the illegal use of drugs shall not be considered a medical examination." 42 U.S.C. 12114(d)(1).
Besides a lack of jurisdiction, the FDA's proposed "cost bundling" regulation for on-site drug tests would significantly and unnecessarily drive up the costs to employers of administering the tests. It does not make sense to mandate that the cost of confirmatory lab tests be included in the original cost of on-site tests when less than five percent of all workplace drug tests require confirmatory follow-up. 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.
We again urge FDA to look at the facts, consider its statutory authority and legal jurisdiction, and reconsider regulation of on-site workplace tests used to indicate illegal drug use. Thank you for your consideration of this important workplace safety issue. We will be happy to discuss this matter further if you have questions.
Mark Souder Elijah Cummings
Chairman Ranking Member
cc: Honorable Tommy Thompson
Department of Health and Human Services