|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 :||EC901|
|Submitter :||Ms. Amy Oggel||Date & Time:||10/17/2005 11:10:05|
|Organization :||Ms. Amy Oggel|
|Category :||Health Professional|
| I urge the FDA to grant Plan B over-the-counter status for all women.
FDA's failure to make a decision on the application to make Plan B emergency contraception (EC) available over the counter compromises the health care of women in the U.S. Unintended pregnancy is a significant public health problem in the United States, and women deserve a chance to prevent it. Plan B is a safe, effective, and easy-to-use contraceptive option that will help reduce the need for abortion. The sooner Plan B (note, it is NOT plan A) is available, the fewer abortions that will be necessary.
The necessity of making Plan B available over the counter is made all the more evident by recent actions of pharmacists who have denied filling prescriptions because of the pharmacists' personal beliefs.
American women deserve the best health care possible and Plan B - a safe, effective medication - is part of that.