Summary of the FDA (Food & Drug Administration) Proceedings
Subject: Over-the-Counter Products
Date: June 28-29, 2000
In May, 2000, I received word that the FDA planned to conduct hearings for over-the-counter products (including the birth control pill), which were held on June 28-29, 2000 in Gaithersburg, Maryland. I wrote to Miss Desantis, the coordinator of this event. She stated that I would have ten minutes (on Wednesday, June 28th) to present my findings about the Pill and breast cancer.
The proceedings started at 8:30 AM and were coordinated by Dr. Robert DeLap who is an internist with a special interest in medical oncology. The meeting consisted of about 15 FDA administrators and about 750 to 1,000 people in the audience. Each speaker could speak for ten minutes and then any member of the FDA could ask questions. The audience could ask no questions. In addition, a handout was submitted to each of the members of the FDA. Finally, we were told that we had until August 25th to submit any written comments, which to my understanding, become part of the public record as do all that was presented at the June 28-29 meetings.
I gave a short presentation most of which was included in my handout. The major studies show that the birth control pill causes breast cancer and that the Pill also causes invasive cervical cancer and early abortions. I stated that 17 out of 20 retrospective studies since 1980 have shown that oral contraceptives increase the risk of breast cancer by about 40% if taken prior to a woman's first live-birth.
After my talk, a number of people came up to me including a lawyer and a consulting group all of whom wanted to have more information about the research and/or book. It appeared to me that the business and lay community in the audience were receptive and that some of the members of the FDA were cool, although Dr. DeLap did conduct the hearing fairly.
In addition, I noted that there were actually no talks in favor of making the Pill over-the-counter, prior to my presentation, which is something I did not expect. (Most of the talks were about making Sunscreen Products more accessible or trying to get other medicines over-the-counter). The next day the report on CNN national news made it sound as if the entire FDA was pushing to have the Pill made over-the-counter. I found this to be more than a simple distortion (fabrication is the term I am looking for), since the only person who spoke directly on the subject of the Pill was I! I told the FDA that I would be submitting my entire book (Breast Cancer: Its Link to Abortion and the Birth Control Pill) as part of the public record soon (the deadline is August 25th, 2000). One reporter told me afterwards that he was going to look at the FDA record for my book and would get the information from my book.
Submitted:
Chris Kahlenborn, M.D.
Presented Material: (The material on following pages were both sent and presented to the FDA)
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