Children of God for Life

4613 Barfield Crescent Rd
Murfreesboro, TN  37128

(877) 488-LIFE
http://www.cogforlife.org

February 28, 2006

Margaret O’K. Glavin, Associate Commissioner for Regulatory Affairs

Department of Health & Human Services/FDA

5600 Fishers Lane

Rockville, MD  20857

Dear Ms. Glavin,

I am in receipt of your letter dated December 9, 2005 in which you have denied our request for personal import of the Takahashi rubella vaccine from Japan.  In your reasoning, you referred us to the FDA guidelines for exercising this option – all of which apply to the circumstances of the families who are seeking the import.  The only exception is that you have stated the individual must make the request for his/her own personal use, which we have now included in the attached three-ring binder.  Enclosed you will find the letters requesting a total of 1,221 doses.

In addition to these letters, there are 714 more doses needed by families in a rural community of Pennsylvania who do not have telephone or computer access and have Dr Reuben Hess to file on their behalf.  Due to patient privacy regulations, Dr Hess mailed each person a release form to be signed, in addition to their letter requesting the personal import. Those letters will also be sent to the FDA as part of our joint request, but we did not want to further delay our response to you.

As I stated in our original letter, our purpose in filing the appeal jointly rather than individually was twofold:

1) To make the application process as simple and unified as possible for the FDA so that you would not be faced with responding to each individual letter, and

2) To offset the high cost of importing a single dose for each family or adult in need of the vaccine, which would be excessively burdensome financially.

You also mentioned in your letter that an IND should be filed for legal distribution of the Takahashi rubella vaccine.  Perhaps you are unaware that this actually commenced in April 2001, followed by extensive correspondence with documentation on the product and finally, a meeting at the FDA on November 22, 2002, attended by Dr. Yoshitake Tanaka of the Kitasato Institute, Japan, Dr William Egan of the FDA and myself.  Dr Egan, Dr. Kathy Carbone, and Dr. C. D. Atreya of the FDA reviewed the Takahashi product information and found no concerns with its safety or efficacy, which has been on the market since 1986 in Europe and Japan.

At the conclusion of that meeting it was decided the easiest method for filing the IND would be through an American pharmaceutical company that would ultimately provide the necessary oversight of manufacturing, clinical trials and US licensing upon FDA approval.  That process is still underway as the Japanese are negotiating contracts for licensing and distribution of both the single dose Takahashi and a combined MMR for the US and Canada.

Meanwhile, there are a significant number of American citizens in need of the rubella vaccine who are abstaining from using the US Merck version, which uses aborted fetal cell lines, due to religious convictions.  Your denial to import the untainted version from Japan appears to constitute an unjust violation of both their civil and religious rights, especially since they are in compliance with the very FDA regulations and website link you referenced in your letter:

http://www.fda.gov/ora/compliance_ref/rpm_new2/ch9pers.html

In deciding whether to exercise discretion to allow personal shipments of drugs or devices, FDA personnel may consider a more permissive policy in the following situations:

1. when the intended use is appropriately identified, such use is not for treatment of a serious condition, and the product is not known to represent a significant health risk; or

2. when

a) the intended use is unapproved and for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means;

b) there is no known commercialization or promotion to persons residing in the U.S. by those involved in the distribution of the product at issue;

c) the product is considered not to represent an unreasonable risk; and

d) the individual seeking to import the product affirms in writing that it is for the patient's own use (generally not more than 3 month supply)and provides the name and address of the doctor licensed in the U.S. responsible for his or her treatment with the product, or provides evidence that the product is for the continuation of a treatment begun in a foreign country.

I should like to point out that every one of these conditions has been met:

• The vaccine does not pose a health risk as already noted by the FDA
• There is no US treatment available for parents opposing aborted fetal vaccines
• The vaccines are not intended for commercial distribution
• The vaccines are for personal use by the families as stated in the enclosed letters.

We are very sensitive to concerns by the FDA regarding proper cold chain and handling in the shipping of the rubella vaccine in the US.  Attached you will find two flow charts showing two different options that could be used at the discretion of the FDA. The Japanese are willing to package the vaccines in such a manner that they will be broken down properly and clearly labeled by Region and physician with the exact number of doses needed for each patient. 

Each doctor will also have copies of the package insert to ensure the vaccines are stored and administered properly.  A copy of the Takahashi package insert was sent to you in our initial correspondence, but I will include a second copy here as well. I have also included the specific packaging instructions and material to be used by Japan, which conform to Industry standards.

Ms Glavin, as it stands now, the delay of over 6 months by the FDA in responding to our initial request has resulted in the forced vaccination of Catholic women in Nursing Medical School who were part of our request for the ethical alternative from Japan. Ultimately, these women had no choice but to use the tainted rubella vaccine or face expulsion and the end to their careers. It was a heartbreaking choice for them and a gross violation of their moral conscience. The fact that the FDA had full authority to allow the import and chose not to do so is an unnecessary travesty of justice.   

We ask that you take this matter under serious consideration for not only Catholics, but for all who find the use of aborted fetal vaccines contrary to their religious freedom and beliefs.

We believe this request to be not only reasonable, but in full compliance with FDA regulations. I do hope the enclosed information satisfies any question you may have, but please call me at 877-488-LIFE if there is something we may have overlooked, or if you have any questions. 

Assuming the FDA will allow the import after you review the enclosed plans, we will notify all families and physicians and coordinate the next steps to be taken in accord with the FDA.  We are willing to work very carefully with your offices to ensure complete compliance for the safety and well being of all who are applying for this personal import.  Thank you for your prompt attention to our request.

Sincerely,

Debra L. Vinnedge

Executive Director

CC:      Francis J. Manion, American Center for Law and Justice

            Erik Stanley, Liberty Counsel

            Jan Halisky, PA, Children of God for Life, Counsel

            Congressman Bill Young

            Congressman Dave Weldon

            Senator Mel Martinez

            Steven White, Past President, Catholic Medical Association

            Dr Yoshitake Tanaka, Kitasato Institute, Japan

            All enclosed family members, physicians