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 : EC967
Submitter : Ms. Sue Exline Date & Time: 10/27/2005 09:10:40
Organization : Ms. Sue Exline
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?
I urge the FDA to end its delay of the decision to switch Plan B?s drug status to over the counter (OTC). The FDA?s latest move?requesting public comments?is merely a stall tactic that compromises women?s reproductive health options.

Contraceptives are a fundamental element of basic health care. Plan B, a safe and effective form of contraception, decreases the risk of unintended pregnancy. Easy access to this drug is essential. For Plan B to be effective, women must be able to take it quickly, as the efficiency rate decreases dramatically after 12 hours following unprotected sex, birth control failure or sexual assault. Because it is often not possible to quickly schedule an appointment with a health-care provider who will write a prescription, making the drug available OTC is essential to the many women who would not otherwise be able to access it.

Plan B should be made available OTC to women of all ages. The claim that easier access to young women will result in increased rates of unprotected sex among adolescents is simply unsubstantiated.


The FDA has long been hailed as an independent entity that promotes public health through science and evidence, not ideology and politics. The fact that women have had to wait for more than two years for the FDA to issue a decision on the Plan B application is unacceptable. Please make women?s health the FDA?s first priority by ending this undo delay.


GENERAL
GENERAL
I urge the FDA to end its delay of the decision to switch Plan B?s drug status to over the counter (OTC). The FDA?s latest move?requesting public comments?is merely a stall tactic that compromises women?s reproductive health options.

Contraceptives are a fundamental element of basic health care. Plan B, a safe and effective form of contraception, decreases the risk of unintended pregnancy. Easy access to this drug is essential. For Plan B to be effective, women must be able to take it quickly, as the efficiency rate decreases dramatically after 12 hours following unprotected sex, birth control failure or sexual assault. Because it is often not possible to quickly schedule an appointment with a health-care provider who will write a prescription, making the drug available OTC is essential to the many women who would
not otherwise be able to access it.

Plan B should be made available OTC to women of all ages. The claim that easier access to young women will result in increased rates of unprotected sex among adolescents is simply unsubstantiated.


The FDA has long been hailed as an independent entity that promotes public health through science and evidence, not ideology and politics. The fact that women have had to wait for more than two years for the FDA to issue a decision on the Plan B application is unacceptable. Please make women?s health the FDA?s first priority by ending this undo delay.