Your letters to Secretary Thompson and other staff at HHS and the FDA are having an effect. They have heard the industry's concerns. The FDA has now met with SAMHSA to find out how they have successfully dealt with on-site testing.
We must now focus our efforts on Congress. They have oversight over the FDA and they can engage the FDA's attention in powerful ways. NOTA and DATIA are in Washington meeting with and/or contacting congressional staff and federal agencies. Our meetings have been very successful. We will have more meetings this week. The congressional staff tell us to generate letters.
Below are the names and addresses of the key congressional players on this issue. They need to hear from you now!!!! Send your letters via fax and mail (Fed Ex if you can). the congressional mail is still not working well.
Two sample letters (below) are included, however, we ask that you also provide the facts in your own words. If you have any questions on this issue, you may contact or David Evans (NOTA) at 908-788-7077 or Laura E. Shelton (DATIA) at 800-355-1257.
You can address your letter to all of them. if you already sent a letter to Secretary Thompson, just attach a cover letter and send it the members of Congress.
If you are from the member's district, please mention that in your letter in the first sentence. their districts are:
Congressman Rob Portman (R 2nd OH)
Congressman Mark Souder (R 4th IN)
Congressman John Mica (R 7th FL)
Congressman Elijah Cummings (D 7th MD)
Congressman Jim Greenwood (R 8th PA)
Congressman Peter Duetsch (D 20th FL)
Senator Charles Grassley (R IA)
Senator Joseph Biden (D DE)
SEND YOUR LETTERS TO:
Congressman Rob Portman
Co-Chairman Speaker's Task Force for a Drug-Free America
238 Cannon HOB
Washington, DC 20515
fax 202-225-1992
Congressman Mark Souder
Chairman Subcommittee on Criminal Justice and Drug Policy
B-373 Rayburn HOB
Washington, DC 20515
fax 202-225-1154
Congressman John Mica
Co-Chairman Speaker's Task Force for a Drug-Free America
2445 Rayburn HOB
Washington, DC 20515
fax 202-226-0821
Congressman Elijah Cummings
Ranking Member Subcommittee on Criminal Justice and Drug Policy
1632 Longworth HOB
Washington, DC 20515
fax 410-367-5331
Congressman Jim Greenwood
Chairman Commerce and Energy Subcommittee on Oversight and Investigations
2436 Rayburn House Office Bldg.
Washington, DC 20510
fax 202-225-9511
Congressman Peter Duetsch
Ranking Member Commerce and Energy Subcommittee on Oversight and Investigations
2421 Rayburn House Office Bldg.
Washington, DC 20510
fax 202-225-8456
Senator Charles Grassley
Co-Chairman Senate Caucus on International Narcotics Control
135 Hart Senate Office Building
Washington, DC 20510
fax 202-224-6020
Senator Joseph Biden
Co-Chairman Senate Caucus on International Narcotics Control
221 Russell Senate Office Building
Washington, DC 20510
fax 202-224-0139
MODEL LETTER # 1
Dear Congressmen and Senators
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 IN 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 over the counter 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 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 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,
MODEL LETTER # 2
I am writing to you to urge that you ask the FDA to consider the full impact of imposing new regulations for on-site drug testing that will adversely affect the health and safety of our nation.
The FDA is considering imposing unnecessary and costly regulations for on-site drug tests. This will greatly affect the cost of these tests and thus substantially decrease the use of on-site drug testing just at the time when on-site drug testing has been proven to substantially reduce drug use and just at the time when we need drug testing to be a tool in keeping our homeland safe.
This FDA action will assure that small businesses cannot afford the costs of using drug tests. Small businesses will not be able to afford tests that are urgently needed to keep illegal drug use out of the workplace, including security related jobs. The proposed costly increase in regulation of this industry, when the industry has a good reputation is irresponsible. Further, the resultant decrease in drug use testing will send the wrong message to children who are about to enter the work place. Implementation of the FDA proposed regulations would decrease the effectiveness of our war against the terrorist drug kings and pushers. It will increase the health risks of this nation.
Use of drug testing in the military has been the principal component in reducing drug use by the military to less than 1%. On-site drug testing is one of the most effective components of our war on drugs. Certainly, we should be supporting not hindering this industry, which has been a cost effective component in our fight against drug use.
Sincerely yours,
