Step by Step guidelines for participating in the mailout to the FDA 2003D

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Step by Step guidelines for participating in the GG protest to the FDA
2003D-0478; Draft Guidance on Marketed Unapproved Drugs Compliance Policy Guide; Availability 10/20/03 12/22/03)

Click here to download the 8-page Guai-Support Response to the FDA to your computer.

SAVING AS A TEXT FILE
1. Click here to download the letter (this window will remain open for reference);
2. Go to ‘File’ on the browser menu;
3. Select ‘save as’ off the menu list;
4. In the ‘SAVE IN’ section, at the top of the save dialogue box, select the folder where you want to save the file;
5. In the FILE NAME section, type an easy to remember name (e.g., GG FDA Letter);
6. In the SAVE AS TYPE section, select Text File (*txt);
7. Choose ‘save’.
SAVING AS A WORD FILE
1. Click here to download the letter (this window will remain open for reference);
2. Go to ‘Edit’ in the browser menu;
3. Select ‘select all’ off the menu list;
4. Select ‘copy’ from the edit menu;
5. Open ‘WORD’ at a ‘blank’ page;
6. Select ‘Edit’ on the Word menu;
7. Select ‘Paste’ on the ‘Edit’ menu:
8. Go to the WORD ‘file’ menu and select ‘Save As’
9. Choose the folder where you want to save the file;
10. Type an easy to remember name (e.g., GG FDA Letter);
11. Choose ‘save’.
If you have difficulty with any of this, click here to contact the GG PROTEST HELP DESK, who will be very happy to guide you through the process.
Print out the letter
Insert your signature (UNDER Kathy's signature) thus:

The signatory/signatories agree/s with the content of this letter and requests FDA action.
Your name
City, State
Country
insert 'current' date here
CC:
If you are a member of Guai-Support you may elect to sign it thus:
The signatory/signatories agree/s with the content of this letter and requests FDA action.

Your name
International Guai-Support Group member
City, State
Country
insert 'current' date here
CC: Names of Governors, senators, and their representatives in the house, to whom you wish to copy this letter.

USA Citizens Click here to find your senators and their representatives. Insert your zip code in search box at top pf page & hit 'enter' button. When pictures of your elected officials appear, click on info below each picture to get mailing addresses.

Citizens of other countries might consider writing to their own reps, or sending copies of the GG letter to them, along with their own questions about what THEIR governments are doing about the Guaifenesin situation. Ask them to weigh in government to government. We are not sure if this will have any impact however, nothing ventured, nothing gained.

Another option for citizens of other countries is to click here to ATTACH our letter to President Bush via e-mail. You can copy/paste this cover page statement into the e-mail window if it suits, or write one of your own:

"Dear Mr President, I am a citizen of COUNTRY and I am affected by the FDA action in relation to guaifenesin. I have many friends in the USA who support my right of access to affordable drugs. This is a human issue not an American issue. The USA, like my own Government, promotes the notions that globalization and free trade will enhance our lives and that we should support them. If the FDA action is an example of the effects of those inter-governmental agreements (over which citizens will have no control) I certainly see no reason why I should give them my support. The attachment is a letter, sent to the FDA, representing the views and protests of the members of a support list for people using guaifenesin to reverse the effects of Fibromyalgia, a disease that affects millions."

Many e-mail programs have an attachment icon on a tool bar but if your's doesn't it may be in the MESSAGE menu, under ATTACH FILE or in the INSERT menu. If neither of these are an option here are some generic attachment instructions:
1.      Open EXPLORER (or whatever file management program you use);
2.      Find the FDA letter you saved;
3.      Right mouse click on the file;
4.      Select ‘copy’;
5.      Return to the email;
6.      Right mouse click where you want to insert the file;
7.      Select ‘paste’;
The letter is now ‘attached’ to the email

If you need help with your email attachment please click here to access the GG PROTEST HELP DESK

If you wish to join Guai-Support in order to sign our letter, please click here.
If you have problems with the process, click here.
To access help from a GG protest team member click here.
Insert the letter into a large envelope and address it to:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
Place an .83 stamp on the envelope (or just add 3 letter stamps if you do not have smaller denominations). [We've sent our's via “Registered Mail + Return Receipt Requested” which costs $4.65). It isn't essential so please do what is suitable for you.]
Write a simple cover letter in email to the congressional representative you CC'd above in the FDA letter explaining that:
'The attached is a copy of a letter I just mailed to the FDA addressing an issue of great concern to me. It is sent as background and to indicate my wider concerns.' (Your cover letter may include a brief outline of your personal FMS history if you wish. What you write is up to you but keep in mind that brevity is important to official bodies and more credence is given if the content is calm, to the point and with respect.)

(Also, remember that they will not understand all the abbreviations we use on the list and between those who are in our 'community', so spell out the full terms (e.g., salicylate, Fibromyalgia, extended-release Guaifenesin, immediate-release Guaifenesin, etc.) at least the first time they're used in the letter. Put any abbreviation of a term, that you intend to use from then on, in brackets after the full term, e.g., Fibromyalgia (FMS), to allow them to understand when they encounter the abbreviation further down your letter. )
Sign your full name, address & date where appropriate.
Use your email 'attachment' option to attach the copy of the FDA letter (which you already downloaded to your computer) If you need help with this please click here.
'Send' to the representatives you CC'd in your letter to the FDA
If you wish to go public, let us know via the mailing list (subject line: Guai: Protest Strategies, I protested!) or if you prefer, click here to send it to the GG Protest Team privately.

If you wish to send via snail mail to your representatives this is the alternative method:

Print out your cover letter.
Sign your full name, address & date where appropriate.
Put on top of another signed copy of the FDA letter (as per above).
Put both letters into a large envelope.
Address the envelope to the representatives you've listed in the CC at the bottom of your FDA letter.
Add .60 postage stamp (or send via “Registered Mail + Return Receipt Requested” which costs $4.65).
Mail both your letters A. S. A. P. The deadline for the FDA response is December 22, 2003
If you wish to go public, let us know via the mailing list (subject line: Guai: Protest Strategies, I protested!) or if you prefer, click here to send it to the GG Protest Team privately.