|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 :||EC1461|
|Submitter :||Miss. Vicki Djonaj||Date & Time:||10/28/2005 03:10:56|
|Organization :||Miss. Vicki Djonaj|
|Category :||Drug Industry|
| 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.
|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.
|C. If so, would a rulemaking on this issue help dispet that confusion?|
|A proposed rule with its lengthy comment and review process is being suggested only to drag out the time period before a final decision on EC -|
| OTC is made. It is completely unnecessary.
| 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?|
| There are many items, such as alcohol or tobacco, that require identification and age requirements. However, those same requirements for the sale of emergency contraception intrudes on privacy. Reproductive matters and prevention are personal. The FDA is responsible for deciding the safety of EC, not the morality behind it. |
|B. If it could, would it be able to do so as practical matter and, if so, how?|
|If there were an age requirement, it could be carried out simply, such as for the sales of alcohol and tobacco. However, again, it is not necessary.|
| 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.
| 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.