Written Testimony of Carole S. Denner Concerning the Morning-After Pill     12/16/2003
By Carole S. Denner

Written submission to: 2001P-0075 Joint Meeting of the Nonprescription Drugs Advisory Committee and the Advisory Committee for Reproductive Health Drugs

New Drug Application 21-045, Plan B
Date: 12/16/2003

From: Carole S. Denner, BSN, R.N.,C.
8303 Forrester Blvd.
Springfield, Virginia 22152
H-703-451-0126
C-703-314-6865

Representing: Concerned Women for America of Virginia
P.O. Box 1101
Sterling, Virginia 20167
703-444-1740
www.cwfa.org/states

Over-the-counter (OTC) approval of Plan B places the health and safety of America's women and teenaged girls at risk.

OTC labeling conveys the impression that a drug has been determined safe if used as labeled, without long-term health risks. However, the approval of high-dose hormone therapy (such as Plan B) to decrease the expected birth rate after unprotected sexual intercourse was not based on controlled scientific studies. The approval was based completely on unscientific, anecdotal evidence. Availability of this hormone regimen without a woman's evaluation by a health care professional places the health and safety of women and girls at risk. Neither Plan B, Preven, nor any combination of other pharmaceutical preparations for postcoital use should be available unless a woman has been evaluated according to the standards of good medical practice by a professional educated and licensed to evaluate and prescribe.

A drug's safety at one dose or range of doses does not mean that the drug is equally safe at a much higher dose. The opposite is often true. Most drugs have a maximum safe dose. Exceeding that safe dosage range can place a person at risk for injury or death. The maximum safe dose for levornorgestrel (the active ingredient in Plan B) has not been determined by scientific study. It is unknown whether there is a maximum safe daily dose, monthly dose or yearly dose. The health risks for those who would use Plan B (ranging in age from puberty, about age 12, to women in their 40s) are unknown.

• In 1997, Dr. David Kessler, then the FDA Commissioner for Food and Drugs, concluded, without specific studies on this use, that the hormones used in combined oral contraceptives were safe to use in much higher doses to lower the expected birth rate after unprotected sex. (Please see the Federal Register notice citation included.) This notice requested new drug applications (NDAs) for this postcoital use. The background information in the notice focused on the safety and effectiveness of combined oral contraceptives when taken three weeks out of four, emphasizing that doses had been reduced since the introduction of oral contraceptives, creating improved safety. The notice referenced no studies on the effects of these higher doses to women's safety. It only referred to studies that showed the drug regimen lowered the expected birth rate.

Food and Drug Administration
[Docket No. 96N-0492]

Prescription Drug Products; Certain Combined Oral Contraceptives for Use as Postcoital Emergency Contraception
[Federal Register: February 25, 1997 (Volume 62, Number 37)]
[Notices]
[Page 8609-8612]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25fe97-139]
http://www.fda.gov/opacom/fedregister/cd96107.htm

The real safety of medications can only be determined if health professionals trained to identify side effects follow the individuals receiving the medications over an extended time period. A serious side effect may not be immediately apparent. This training includes identifying long-term effects and side effects that are impacted by other personal factors (such as age, other medical conditions, or other regularly used medications).

• None of the 21 references included with Prescription Drug Products; Certain Combined Oral Contraceptives for Use as Postcoital Emergency Contraception, FDA, [Federal Register: February 25, 1997 (Volume 62, Number 37)] addressed the effects on women; instead, they addressed only the drug's effectiveness of lowering the expected birth rate. Yet, the conclusion was reached that the drug regimen was "safe and effective." The conclusion was based on the years of use in the U.S. and other countries, even though there was no attempt to screen for serious side effects. This is not a scientific conclusion. Problems could have occurred, but the women involved did not connect the problems with the drug they received.

• I have found no longitudinal studies (studies which track over a period of time) of the women who have taken this high-dose hormone regimen. All studies (including those cited in this OTC approval application) focus on their relative reliability in decreasing the expected birth rate, not on the effect on the women who have taken the drug regimen. Women's Capital Corporation and Barr Laboratories advocate the unrestricted availability and use of Plan B, even though no studies have been done to determine if the higher doses of this drug have any long-term safety risks for women. There is no proof of this product's safety for women. OTC labeling would give a false sense of safety not supported by scientific research.

Both the American Medical Association (AMA) and the American College of Obstetricians and Gynecologists (ACOG) continue to recommend that low-dose oral contraceptives be available only with a prescription from a licensed health care provider, while recommending that Plan B and other higher dose hormone regimens be available OTC. If the hormones are not safe for a woman or girl to prescribe for herself in low doses as routine oral contraceptives, they can't be safe in the larger doses found in Plan B and other morning-after pills.

The information presented by the Women's Capital Corporation and Barr Laboratories for the OTC approval of Plan B only illustrates that they are more interested in their profit margin than in women's health and safety.

I and the more than one-half million members of Concerned Women for America ask the FDA to safeguard the health and safety of America's women by prohibiting the use of any high-dose hormones except by prescription. Only those health care professionals who, by their education and licensure, can first evaluate and examine women in accordance with current standards of good medical practice should be able to prescribe Plan B or other high-dose hormones.

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