Letter from the FDA's Dr. Hager on Plan B decision

Today, AAPLOG distributed the following letter from Dr. David Hager. Hager took tremendous heat in 2004 as one of four (of 27) members of an FDA advisory panel voting against making Plan B available over the counter:

I have been interviewed so much recently regarding the FDA's Plan B decision and subsequently misquoted so much that I wanted to make sure each of you were aware of what "I really think" about the issue.

As you know, from the very beginning I attempted to emphasize at the FDA level that we lacked any data on long-term or multiple dose use of levonorgestrel. I also emphasized that the Label Comprehension Study presented by the sponsor revealed that 1/3 of the women did not comprehend that EC was not for routine use. In addition, there was no literacy evaluation for women <18 years of age.

We are talking about a hormonal medication (high-dose progestin) that will not require a prescription for women (or men) who are 18 years of age or older. This in spite of the fact that the FDA still requires a prescription from a medical provider for birth control pills, even in very low-dose strengths.

The safety profile for Plan B is excellent, but those data were gathered from single-dose use with careful followup in a research setting.

We have no data on the effects on women of multiple dose use. Recent information from Europe indicates that when EC is available OTC [over-the-counter] or by advanced provision, the average sexually active female uses the medication multiple times during the month in place of routine contraception.

Since the window of opportunity for conception for a woman is approximately 36 hours a month, 95% of all uses are unnecessary. (60 twelve hour segments in a 30 day month with 1 1/2 of those segments available for conception = 5%.) I was asked by reporters, "Do you think the 18 year old age limit is better than the 16 year old limit?" I answered, "It is better, but it is not the answer since it will not be enforceable." I was quoted in the press as saying, "Hager favors 18 year old age limit."

Finally, in PP own studies they have shown that advanced provision of EC does not reduce abortion rates (Glasier A, Fairhurst K, Wyke S, et.al. Advanced provision of emergency contraception does not reduce abortion rates. Contraception 2004;69:361-66), nor does it reduce unintended pregnancies (Raine TR, Harper CC, Rocca CH, et.al. Direct access to emergency contraception through pharmacies and effect on unintended pregnancy and STIs: A randomized control trial. JAMA 2005;293:54-62.)

I have never claimed to be the brightest light in the house, but it doesn't take a genius to realize that this was not a good decision from a medical perspective. I still believe that this can be argued from a scientific perspective without having to even address the issue that the PDR lists an endometrial effect as a possible mechanism of action.

Translating Hager's last sentence: The Physician's Desk Reference (doctors' bible) still lists the potential for Plan B to stop an embryo from attaching to the wall of the uterus (endometrium).