2005N-0345
FDA Comment Number : EC1518
Submitter : Ms. Sarah Hillenbrand Date & Time: 10/31/2005 09:10:57
Organization : Ms. Sarah Hillenbrand
Category : Individual Consumer
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC drug product?
The FDA should approve without further delay over-the-counter (OTC) sale of emergency contraception - with no prescriptions required for any age group. And it should be illegal for a pharmacist to not fill the prescription.
The two advisory FDA committees that exhaustively reviewed data in December 2003 found that emergency contraception was safe and effective and consequently recommended OTC approval.

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 have endorsed EC access for women of all ages. The American Academy of Pediatrics has urged its members to "help ensure that all adolescents have knowledge of and access to contraception, including barrier methods and EC supplies.

When the age restriction was suggested at the December Advisory Committee meetings, the FDA staff noted then that it has been the policy of the Division of Reproductive and Urologic Drug Products to make no distinction between post-pubescent adolescents and adult women insofar as contraceptive use is concerned. The Advisory Committee members then rejected the age restriction proposal.

The apparent move by the agency to restrict access to young women, 16 years of age and younger, therefore flies in the face of the recommendations of the majority of respected medical professional associations and the government's own stated policy.


1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously market in both a prescription drug product and an OTC drug product?
see above
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Only by considering an age limit. Given the prevailing medical opinions on the subject, age should not be a factor in making emergency contraception available over the counter.
C. If so, would a rulemaking on this issue help dispet that confusion?
I feel it is unneccessary. Proceed immediately to ensure better access to this very important health-saving drug. Women should have control over their bodies and it should not be limited or delayed any longer.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a matter of law?
Limiting access to a legal drug in this way would be discrimination and a dangerous act towards women's health. Certain group's religious beliefs should not limit the majority's access to possible life-saving medicine. Emergency contraception is a safe way to protect against an unwanted pregnancy. This is a significant option for a woman to have that may make an abortion later unnecessary. This alone is an enormous contribution to society and the woman's health.
B. If it could, would it be able to do so as practical matter and, if so, how?
It would not be practical nor respectful of privacy to require individuals of a certain age group to have ID. Rape knows no age limit unfortunately and if a woman is raped by a family member or relative, requiring permission may be an impossibility. Restrictions in access to emergency contraception could endager the life of the woman.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?
Making EC universally available would obviate the need for separate packaging.


B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
There would not be any circumstances that would be inappropriate for a single package.


GENERAL
GENERAL
This latest tactic to further delay making the correct decision to approve universal, over-the-counter availability of emergency contraception is an insult to all women. It further discredits the Food and Drug Administration as a responsible, professional science-based organization. The proposal to restrict access of EC ? OTC to women 16 and under makes no rational or practical or medical scientific sense. Determination of the safety and effectiveness of emergency contraception, with the added public health value of preventing unintended pregnancies ? no matter the age of the woman - should be primary criteria for making this decision. What could possibly be the public health value in restricting access to adolescents ill- prepared ? emotionally and physically ? to carry a pregnancy to term? We agree and the data indicate that access to emergency contraception will not encourage promiscuity or that EC would lessen the routine use of contraception.

Some 39 nations have made emergency contraception available without prescription and 8 states in the U.S. have now adopted a process to streamline access of emergency contraception. The FDA's delay and ill-advised intention to restrict access to women 16 and younger is
unacceptable and intolerable. Please make the decision to allow emergency contraception available to all women, all ages, and no restrictions.