<<Disclaimer: Verify this information before applying it to your situation.>>



This is a response from the drug portion of the FDA. It gives some really good info as to how to go about getting some action on the prescription drug issue as far as allergens go and also gluten with Celiacs. Anyone who has a reaction needs to call or send a statement to the below phone numbers provided or email contact so they can be aware of the problems. Like I said, some exciting steps that we can take to help assure we get drugs either labeld with the offending inactive ingrediants or as they say, completly removed from being allowed in the prescription drugs!

Betty




Dear Betty: 

Thank you for your message to the Center for Drug Evaluation and 
Research (CDER), one of the five centers within the Food and Drug 
Administration (FDA). 

Your comments are well received. As you are probably aware, most 
allergens in prescription drug products are inactive ingredient. An 
inactive ingredient is any component of a drug product other than the 
active ingredient. An active ingredient is any component of a drug 
product intended to furnish pharmacological activity or other direct 
effect in the diagnosis, cure, mitigation, treatment, or prevention of 
disease, or to affect the structure or a ny function of the body of 
humans or other animals. Active ingredients include those components of 
the product that may undergo chemical change during the manufacture of 
the drug product and be present in the drug product in a modified form 
intended to furnish the specified activity or effect. Although inactive 
ingredients are required to be listed on the label of over-the-counter 
(OTC) drug products, the Federal Food, Drug, and Cosmetic Act (the Act) 
generally does not require the declaration of inactive ingredients on 
the labels of prescription drugs. To have the Act amended to include 
this requirement would require an act of Congress. Perhaps you may wish 
to contact your state representative in the House of Representatives 
and/or Senate to express your concerns. 

At present, FDA's policy is to deal with those ingredients that are 
clearly implicated as causing reactions in a significant portion of the 
population. The FDA monitors adverse experiences or product problems, 
including adverse experiences to inactive ingredients via its MedWatch 
program. This program is a voluntary system of reporting to FDA 
problems patients' experience with products we regulate. We view this 
reporting system as a source for signaling trends. Should a trend 
emerge, the FDA will work with the sponsor of the product to address the 
problem. Actions may include changes in the labeling information or 
product packaging, change in manufacturing processes, enhanced warnings 
in the labeling or communications to health care professionals. In the 
most serious cases or where other attempted actions have not been 
effective, the sponsor may decide to remove the drug from the market or 
the drug may be recalled. 

As information becomes available to FDA indicating a relationship 
between a particular inactive ingredient and a potential hazard to 
consumers, pertinent steps may be taken either to require appropriate 
labeling or to prohibit the use of those ingredients in prescription 
drugs. This was the basis for the ruling on FD&C Yellow No. 5, a 
potential sensitizing agent for many individuals. FDA published a final 
regulation in the Federal Register of June 26, 1979, stating that foods 
and certain drugs for human use which contain FD&C Yellow No. 5 must 
bear a label declaration to that effect. 

If you ever suffer an adverse event to a drug product I urge you to 
report it. We now have a new way to report directly to MedWatch via the 
Internet. You can find a link to the Internet voluntary reporting form 
by going to the MedWatch homepage 
(http://www.fda.gov/medwatch/index.html),click on "How to Report", then 
"Reporting by Health Professionals" or "Reporting by Consumers". In 
addition, if you would like to report your adverse experience directly 
to the MedWatch Program, please call 1-800-FDA-1 088. Alternatively, you 
can call our Office of Drug Information at 301-827-4573, and request 
that a MedWatch packet be sent to you. 

The way that industry, consumer groups, and individuals can influence 
FDA to make a change in a regulation or to take other action is to 
submit a citizen petition. A petition requests the FDA Commissioner to 
establish, amend, or revoke a regulation or order, or to take or not to 
take any other form of administrative action, under the laws 
administered by FDA. Citizen petitions are placed in a public docket, 
allowing for public review and comment. CDER is then required by law to 
evaluate and respond to the petition. 

Citizen petitions require careful preparation by the submitter. If you 
still feel strongly regarding inactive ingredients not being listed on 
Rx drug labels and think you wish to submit a citizen petition, please 
review the following publication "Making Your Voice Heard at FDA: How to 
Comment on Proposed Regulations and Submit Petitions" available on our 
Internet site at http://www.fda.gov/opacom/backgrounders/voice.html. In 
addition, the FDA document entitled "How to Petition the FDA," found on 
our Internet site at 
http://www.fda.gov/ora/fed_state/Small_business/sb_guide/petit.html, 
provides the proper format, content, and language to be used. If 
needed, sections 10.30, 10.33 and 10.35 of Title 21 Code of Federal 
Regulations (21 CFR) are the FDA regulations that describe in detail the 
process for submitting a citizen petition. The Code of Federal 
regulations can also be found on the Internet at 
http://www.access.gpo.gov/nara/cfr/ 

Hope you found this useful. 

Sincerely, 

Division of Drug Information 
D202D 

This communication is consistent with 21 CFR 10.85 (k) and constitutes 
an informal communication that represents our best judgment at this time 
but does not constitute an advisory opinion, does not necessarily 
represent the formal position of FDA, and does not bind or otherwise 
obligate or commit the agency to the views expressed. 


-----Original Message----- 
From: [log in to unmask] [mailto:[log in to unmask]] 
Sent: Wednesday, January 17, 2007 9:47 PM 
To: CDER DRUG INFO 
Subject: DrugInfo Comment Form FDA/CDER Site 



Name: BETTY PARKS 

E-Mail: [log in to unmask] 

Comments: Why have regulations for food labeling of allergens been 
completed, yet allergen labeling for prescription drugs is not in place? 
I have celiac disease and have had incidents where I was made sick from 
gluten containing prescriptions due to the fact that the pharmacuticals 
do not have to disclose this information. This has done further damage 
to my system and in the right situation could kill me. There are also 
many people allergic to dairy, eggs and corn that could be in the 
prescrip tions, so this is not only a celiac problem but affects hundreds 
of thousands of people who are already sick enough to warrant a 
prescription medication. 

URL: 

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