<<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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