2005N-0345 Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
FDA Comment Number : EC1604
Submitter : Ms. Linda Thompson Date & Time: 10/31/2005 01:10:22
Organization : none
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 Food and Drug Administration should simply approve without further delay over-the-counter (OTC) sale of emergency contraception - with no prescriptions required for any age group. This obviates the need for any new rulemaking. 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.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
The Food and Drug Administration's apparent intent to limit access by age has muddled what should have been a clear- cut decision to approve over-the-counter sale of this safe and effective emergency contraception. Stop trying to control womens lives and focus on real and genuine health care issues.


C. If so, would a rulemaking on this issue help dispet that confusion?
Lets quite being managed by the far right, religios groups and corporations and focus on womens health and well being. The only confusin is the needless delay in taking action.
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?
It is unnecessary to control this in the manner you are suggesting. This is just another manner of placing road blocks in from of women to yet again control reproductive rights.
B. If it could, would it be able to do so as practical matter and, if so, how?
I believe that a fair and scietific based assessment is what is needed past that you do not need to intrude into womens lives.
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
Please do the right thing. This delay is unnecessary and is less about sound medical options than about pushing an agenda of control and limiting reproductive rights.