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FDA and Antigens
FDA and Antigens

Dear Concerned Health Professional:

Greetings from the Board and thank you for making our society what it is today!  We are here to serve and you are the reason that our society exists.  You care for and about your patients.  That is why you joined PAAS.  You cared enough to take the time and energy to learn more about allergies in order to address their needs.  Their quality of life is better because of what you do.  In this, we stand united.  We all strive to serve.

Like the allergies you have learned to treat so well, another attack has arisen that threatens the health and safety of your patients.  The FDA has decided to attack many of the extracts that you use in your everyday practice.  In its "infinite wisdom", the FDA has expressed concern that many extracts lack the "scientific evidence" required to prove their safety and efficacy.  You know better.  The extracts concerned have been used safely and effectively for decades.  While allergy immunotherapy is not without risks (medical error and patient individuality), decades of experience have proven the value of these extracts.  Their safely record exceeds some over-the-counter drugs.  Now, with a swipe of a bureaucrat's pen, many of these extracts will cease to be available.

Our objection is two-fold.  Decades of experience are being overlooked because of the false standard of "case-controlled, double-blind" studies.  Perhaps most important, there has never been a documented case of anaphylaxis (much less death) attributed to the quality of the extracts in question.  In short, the FDA is addressing a problem that simply does not exist.  Safety compromised due to abstract quality is simply not at issue here. 
The comment period gives us until April to make a difference.  We must act to protect our patients or more correctly to motivate them to protect themselves against this government intrusion into their health care.

We are therefore asking you to do two things.  First, below you will find links.  One is directly to the FDA regarding this very issue.  Please voice your opposition to the proposed action.  The other links will help you identify your United States representatives (Senate and Congress).  It is imperative that these representatives receive an email and phone call expressing the same thought.  This will take 10 minutes at most.  Secondly, we are asking you to email blast (call them if necessary) your allergy patients to do exactly the same thing.  Please alert your allergy patients to the risk this poses to their health.  Please ask them to do exactly what you have already done.  Act today.

It is critical that you and your patients realize that when Senators and Congressional Representatives receive just a few emails/phone calls on a single issue, they assume thousands of their constituents agree.  We can and will make a difference!  However, this will happen only if we act now.  Please ask yourself what you will do in the next 10 minutes that wilol be more important than protecting the health of your patients (and your career).  If you think that "right will prevail" without you, think again.  You must act and act now.  Paraphrasing the patriot, Edmund Burke, "All that is necessary for evil to triumph is for good people to do nothing".  Do something and do it today.

For your convenience, a sample letter has been drafted, which can be used when contacting the FDA or your federal legislators.  Click 
here to access the letter.  Feel free to edit the wording to personalize it.

Click this link to access the web page for the FDA where comments can be posted:
http://www.regulations.gov/#!submitComment;D=FDA-2011-N-0599-0002

Do you need assistance with finding out who your federal legislative representatives are?  Click the below links and enter your your zip code to learn who represents you in Congress:

To find U.S. Representatives:
http://www.house.gov/ - Top right corner of the screen - enter your zip code and click the GO button.

To find U.S. Senators:
http://www.senate.gov/ - Top right corner of the screen - click the drop-down arrow, click on a state name, then click the GO button.



Home
Mission and History
Officers, Directors and Staff
Spring Training Course & Seminar
Summer 2011 Photo Gallery
Summer Training Course
Meet The Faculty
Exhibitor Invitation
Call for Abstracts
Membership Application
Membership Directory
Newsletter
FDA and Antigens