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Making Your Public Comment to the FDA Commissioner, President Obama, Your Congressperson and Senator

Why It Is Important to Take Action

State legislators (and in emergencies sometimes the President) are responsible for making vaccine laws that require you or your children to use certain vaccines. Federal legislators are responsible for providing oversight on federal health agencies, such as the Food and Drug Administration (FDA), which regulates vaccine safety, and Centers for Disease Control (CDC), which makes national health policy recommendations for mass use of vaccines. 

For participatory government to work, citizens should feel free to express what they need and want to both unelected and elected government officials. The President and the legislators you elect to represent you want to hear from you – their constituent - about issues that concern you because most legislators (as well as the President) want to do a good job AND get re-elected. If they don’t know what the people they represent care about, they don’t know how to take action to be responsive to your concerns. As an American, you have not only the right but a responsibility to participate in a democracy by communicating with appointed government agency officials, your elected state and federal representatives and the President about issues that are important to you and by going to the polls to vote in every election.

TO EMAIL YOUR PUBLIC COMMENT TO THE FDA COMMISSIONER, click here.  Below is a sample letter to help you create your public comment.


Date: XXXXX 

Margaret Hamburg, MD, Commissioner
U.S. Food & Drug Administration
Office of the Commissioner
10903 New Hampshire Ave.
Building 32 - Room 4213
Silver Spring, MD 20993

Re: FDA’s Proposed Rule: Revision of Requirements for Constituent Materials (Federal Register: March 30, 2010; Vol. 75, No. 60). 

Dear Dr. Hamburg:

I am very concerned about vaccine safety standards. We need better testing and labeling requirements for drug companies marketing vaccines in the U.S. I want the FDA to strongly regulate the pharmaceutical industry so that vaccine risks are minimized. 

Merck’s live virus RotaTeq vaccine contains DNA from a lethal pig virus (PCV2) that makes baby pigs very sick with a wasting disease. Yet, Merck has not voluntarily recalled RotaTeq from the market and the FDA has not recommended that the vaccine be suspended until it is cleaned up. If vaccine manufacturers can keep DNA from a lethal pig virus in vaccines, it makes me wonder how many other vaccines contain potentially dangerous ingredients that could cause harm. 

I understand you are proposing a Revision of Requirements for Constituent Materials that would allow one FDA staff employee to grant requests from vaccine manufacturers to change the content and amount of vaccine ingredients, including adjuvants, preservatives, residual protein and antibiotics in vaccines. This removes normal checks and balances in government and is contrary to President Obama’s support of transparency, public participation and collaboration in government. One person should not be in charge of giving permission to drug companies to change vaccine ingredients.

As a citizen concerned about vaccine safety, I oppose the Rule Change you are proposing because it lowers standards for federal vaccine safety regulation and does not include a deliberative process for vaccine ingredient changes. Any changes to vaccine ingredients should include high standards for proof of safety and involve vaccine safety oversight by vaccine advisory committees and strong public participation and comment before they are made. 


Your Name

To help you identify and tell your U.S. Senator or Congressperson in Washington, D.C. how you feel about the proposed FDA Rule Change giving power to one FDA employee to allow drug companies to change vaccine ingredients, you can utilize the free tools provided by the non-partisan civic participation organization Congress.org to make this quick and easy for you.
Be sure to include your name and address at the end and keep a copy for yourself.  It would be very helpful if you could also send a copy of any replies you get from the FDA, President Obama or your legislators to NVIC.  
Type in your zip code below and register with Congress.org to find the name(s) of your Congressperson and Senator and give you access to the tools to personally contact them by email, phone, fax, or mailed letter.


  • Personalize (what this means to you and why - no form letters)
  • Punctual (simple and 1 page or less)
  • Polite ( avoid angry words, be calm and civil, avoid using ALL CAPS)
  • Preference for Electronic Communication (email is more timely, safer, and more ecological than paper letters)

To view NVIC's response to the proposed rule change, click here.

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