|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 :||EC2140|
|Submitter :||Ms. Patricia R Robinson||Date & Time:||10/31/2005 06:10:50|
|Organization :||Brook Lane Health Services|
|Category :||Health Professional|
| 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?|
|FDA should simply approve without further ado OTC sale of emergency contraception. No prescriptions required for any age group. .|
|B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?|
| The FDA's attempt to limit access by age has muddied the waters about what should be a clear-cut decision to approve OTC sale of a safe and effective emergency contraception.
I happen to be a psychotherapist. I know there are young teens who are impregnated by fathers, uncles, you name it. They need to have this safe method available in such cases.
|C. If so, would a rulemaking on this issue help dispet that confusion?|
| It appears to me that a proposed rule and review process will only drag out the time period before a final decision is made regarding the use of this drug OTC. I also personally believe that the drug companies don't want to give up another prescription drug to line their own pockets.|