A THREAT TO THE USE OF ON-SITE DRUG TESTS

WHAT IS HAPPENING AND WHAT YOU CAN DO ABOUT IT

New efforts by the Food and Drug Administrations (FDA) to impose unnecessary and unauthorized regulatory burdens for on-site drug tests threatens to severely disrupt their use 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.

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. The FDA actions are counterproductive for the following reasons:

1. 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 (US Administrative Office of the Courts, U.S. Navy Recruiters, U.S. Marine Corps, Army Nat'l Guard, Ford Motor Co., Pinkerton's, Coca-Cola, Walmart, K-Mart, Union Carbide Corp, Raytheon, Toys R Us).

2. Making employers pay up-front for confirmation tests they may not need does not make sense. FDA claims paying up-front will encourage employers to get positive tests confirmed, but employers do not need such encouragement. They do it now because confirmation is practical. Requiring that consumers prepay for a service they may not use is a disservice to the consumer. If the FDA is concerned about test accuracy, why not make employers pay for confirmation tests in advance when they contract with a laboratory?

3. Other federal agencies and the states already regulate this area. The Substance Abuse and Mental Health Services Administration (SAMHSA) within the federal Department of Health and Human Services (HHS) is issuing new rules incorporating on-site tests into the entire federal drug testing program (over 12,000,000 employees). SAMHSA did major studies of the tests and found them to be accurate and effective as did the federal Administrative Office of the Courts. SAMHSA will not require the cost of confirmation up-front or OTC approval. Employers will only pay for confirmations they need. In addition, most states have laws regulating workplace drug testing and they permit on-site testing without these onerous requirements.

FDA's current regulatory efforts run counter to Congress' long-standing and increasing interest in on-site drug testing as an integral part of cost-effective drug-free workplace programs. And given the importance of workplace testing in assuring the trustworthiness of employees in security-sensitive jobs, such as airline security personnel, police, fire and rescue workers, food and pharmaceutical manufacturing employees, water and other utility workers, and members of the armed forces, FDA's regulatory efforts will clash with the Administration's goal of protecting our homeland.

The FDA action is flawed on jurisdictional and procedural grounds. First and foremost, the FDA has no authority to regulate drug test devices in the workplace - this regulation is outside the scope of FDA's jurisdiction which is to only regulate medical devices intended "for the diagnosis, treatment, mitigation or prevention of disease," 21 U.S.C. §§ 321(h); 21 C.F.R. §§ 809.3. On-site drug and alcohol tests do not diagnose disease - they detect illegal drug use. Congress has been very explicit in its view on this matter in the language of the Americans With Disabilities Act of 1990 where it states that "a test to determine the illegal use of drugs shall not be considered a medical examination." 42 U.S.C. 12114(d)(1). Therefore, test kits intended for such use do not fall within FDA's statutory medical device jurisdiction. There are many non-medical reasons for employers to drug test employees to include: promoting workplace efficiency and safety, promoting public confidence in products, prevention of theft and discouraging illegal conduct by employees.

In addition to a lack of jurisdiction, the FDA has not adopted a clear policy through "notice-and-comment" rulemaking. This would permit a public review of their actions.

WHAT ARE WE ASKING FOR?

We request that FDA announce a moratorium that will allow workplace DOA tests to continue to be marketed without FDA intervention until such time as FDA has properly reviewed this matter and has received guidance from other federal agencies and Congress. We are confident FDA will find, after a thorough review of the facts, that regulation of these simple, non-medical drug use indicators is unnecessary and counterproductive.

THE FDA CONCERNS CAN BE MET

Any FDA concerns can be met if the manufacturers place a statement in their package insert that recommends confirmation of all positives or the FDA can recommend that on-site tests be administered according to the SAMHSA Mandatory Guidelines for Federal Workplace Drug Testing Programs. SAMHSA requires confirmation of positive results and the use of trained test operators. Because of the nature of on-site tests, we need only insure that the test operators are properly trained in the use of the tests in order for them to be accurate and the results properly interpreted.

The US Postal Service is considered to be the largest, decentralized on-site drug-testing program in the world. Each year since 1998 an estimated 250,000 perspective Postal Service job applicants are tested with on-site drug tests. The program is very successful.

WHO DO YOU WRITE TO?

Please write to the following people. A MODEL LETTER FOLLOWS BUT USE YOUR OWN WORDS. YOU DO NOT HAVE TO ADDRESS ALL THE POINTS IN THE LETTER. You can address it to all three people in the same letter but make sure each one is sent their own copy. Send via Fed Ed and fax. Send via fax because the mail to federal agencies may not go through. You can also fed ex it but make sure you have your phone number on it so they can call to confirm you sent it otherwise they may not open it. Their faxes are: Mary Kay Mantho 202-690-7098; Daniel Troy, Esq. 301-827-3054; Tommy Thompson 202-690-7595.

MODEL LETTER - YOU CAN USE ONE OR MORE OF THESE POINTS

The Hon. Tommy G. Thompson
Secretary
Department of Health and Human Services
200 Independence Avenue, SW
Room 603-F
Washington, DC 20201
Fax: 202-690-7595

Ms. Mary Kay Mantho
Senior Policy Advisor to the Secretary
Department of Health and Human Services
200 Independence Avenue, SW
Room 603-F
Washington, DC 20201
Fax: 202-690-7098

Daniel Troy, Esq.
Chief Counsel
Food and Drug Administration
GCF-1
Room 657
5600 Fishers Lane
Rockville, MD 20857
Fax: 301-827-3054

Dear Secretary Thompson, Ms. Mantho and Mr. Troy

We are writing to you because new efforts by the FDA to impose unnecessary and unauthorized regulatory burdens for on-site drug tests threatens to severely disrupt their use when they are now urgently needed to keep illegal drug users out of the workplace, especially in security related jobs and the military. Increased regulation of this industry is irresponsible and counter to the national security interests of the United States.

We use the ....... on-site drug test. DESCRIBE BRIEFLY HOW YOU USE IT. ONE TO TWO SENTENCES.

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 OTC approval. These requirements would dramatically and unnecessarily increase the cost of testing. This is counterproductive for the following reasons:

1. 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. We have used them and have found them to be easy to use and interpret and they are accurate.

2. Making employers pay up-front for confirmation tests they may not need does not make sense. FDA claims paying up-front will encourage employers to get positive tests confirmed, but we do not need such encouragement. We do it because confirmation is practical. If the FDA is concerned about test accuracy, why not make employers pay for confirmation tests in advance when they contract with a laboratory?

3. Other agencies and the states already regulate this area. The proposed FDA policy is contradictory to current practice and policy of these agencies. In addition, most states have laws regulating workplace drug testing and they permit on-site testing.

4. The FDA actions will shut down the availability of on-site tests. This is particularly troublesome given the increased need to assure drug-free employees for important security-related jobs such as security personnel, police, fire and rescue workers, food manufacturing, food service, water and other utility employees and members of the armed forces.

5. FDA's current regulatory efforts would run counter to Congress' long-standing and increasing interest in on-site drug testing as an integral part of cost-effective drug-free workplace programs.

6. The FDA action is flawed on jurisdictional and procedural grounds. The FDA has no authority to regulate drug test devices in the workplace. FDA's jurisdiction is only to regulate medical devices intended "for the diagnosis, treatment, mitigation or prevention of disease," On-site drug and alcohol tests do not diagnose disease - they detect illegal drug use. There are many non-medical reasons for employers to drug test employees to include: promoting workplace efficiency and safety, promoting public confidence in products, prevention of theft and discouraging illegal conduct by employees.

In addition to a lack of jurisdiction the FDA has threatened to begin enforcement even though it has not adopted a clear policy through "notice-and-comment" rulemaking.

SAMHSA and DOT have just spent several years evaluating on-site tests and are about to approve them for all federal workplace drug testing. Why does the FDA desire to repeat work that has been done and engage in unneeded regulation? After several studies and years of testimony and investigation, SAMHSA decided that on-site tests were reliable and can be used when the test operators are trained by the manufacturers or their agents. In addition, 29 states have laws that regulate employment drug testing.

We request that the FDA announce a formal enforcement moratorium that will allow workplace DOA tests to continue to be marketed without FDA intervention until such time as FDA has properly reviewed this matter and has received guidance from other federal agencies and from Congress.

The FDA concerns can be met if the manufacturers place a statement in their package insert that recommends confirmation of all positives or the FDA can recommend that on-site tests be administered according to the SAMHSA Mandatory Guidelines for Federal Workplace Drug Testing Programs. SAMHSA requires confirmation of positive test results and the use of trained test operators.

We thank you for your attention to this matter. We will be happy to provide more information if requested.

Sincerely yours,

If you have any questions on this issue, you may contact Laura E. Shelton (DATIA) at 800-355-1257 or David Evans (NOTA) at 908-788-7077.