October 31, 2005

Food and Drug Administration
Division of Dockets Management
5630 Fishers Lane, Room 1061
Rockville, MD 20852

RE: Docket Number 2005N-0345

Dear Acting Commissioner von Eschenbach:

We, the undersigned organizations representing the women’s health community, write to you in response to the Advance Notice for Proposed Rulemaking in docket number 2005N-0345.

We strongly urge the FDA to abandon the proposed rulemaking, an ill-advised and unnecessary attempt to restrict access to Plan B emergency contraception, and to approve over-the-counter availability for women of all reproductive ages.

Such approval is what the Agency’s two independent expert advisory committees overwhelmingly recommended on December 13, 2003 and it is also what the vast majority of your professional medical and scientific staff recommended.  Indeed, OTC access for women of all reproductive age has been widely endorsed by more than 70 professional medical and public health associations, including the American Medical Association, the American College of Obstetricians and Gynecologists, and the Society for Adolescent Medicine.  In July, the American Academy of Pediatrics recommended its 60,000 members “help ensure that all adolescents have knowledge of and access to contraception, including barrier methods and EC supplies.”

The question of a potential age restriction was raised and discussed at the December 2003 Advisory Committee meeting and was rejected by committee members and, again, by FDA staff who pointed out that it is the long-standing policy of the Division of Urologic and Reproductive Health Products to make no distinction between post-pubescent adolescents and adult women with respect to contraceptive products.

There is no medical or scientific evidence to support the FDA’s implied concern that ready access to Plan B would encourage promiscuity among young adolescents or that it would undermine consistent use of other contraceptives. Instead a growing body of scientific literature confirms that easier access to emergency contraception results only in its more timely use, not in any undesired health consequences.

Prescription requirement for this time-sensitive medication is a barrier to access for women of all ages, particularly those who do not have health insurance or routine access to a health care professional.  A prescription requirement for young adolescents would compromise efficacy in an age group for whom unintended pregnancy has the most serious negative consequences.

OTC access to Plan B is a common sense, common ground solution to reducing the rates of unintended pregnancy and abortion in the United States. Plan B needs to be on the counter with condoms and other over-the-counter contraceptives to encourage use of the product. A dual status product will force Plan B behind the counter in most pharmacies, needlessly increasing the cost and burden to pharmacists and to women, and likely, discourage use.

The resignations of Dr. Susan Wood, Director of the Office of Women’s Health, and Dr. Frank Davidoff, consultant to the FDA and former member of the Nonprescription Drugs Advisory Committee, underscore the importance of making an evidence-based decision on the application – one that is not guided by politics – to restore and maintain the integrity of the FDA.

We strongly urge the FDA to abandon the proposed rulemaking process and approve the original application to switch Plan B to an over-the-counter product with no restrictions.

Sincerely,

Paul Blumenthal, MD, MPH
Shari Brasner, MD
Nancy Jasper, MD
James Trussell, Ph. D
Carolyn Westhoff, MD
Mimi Zeiman, MD