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 : EC895
Submitter : Dr. Karen Holden Date & Time: 10/17/2005 11:10:11
Organization : UCSF
Category : Health Professional
Issue Areas/Comments
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously market in both a prescription drug product and an OTC drug product?
If a there is evidence that a prescription drug poses a particular risk to a particular subgroup of the population, then the FDA may impose added restrictions for that group, including marketing the drug simultaneously as OTC and prescription. However, the definition of risk should encompass only safety or efficacy of the particular medication, and should be based on accepted evidence. Any other basis or concern used to deny access to medication to a partcular subgroup is beyond the legitimate interest of the FDA.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
The confusion arises from FDA's seeming to ignore the advise of its professional staff and instead to bow to political pressures from the religious right.
C. If so, would a rulemaking on this issue help dispet that confusion?
Only if the rulemaking were based on legitimate concerns about the SAFETY and EFFICACY of a particular medication in a particular subgroup. Rulemakings done for the sole purpose of social engineering at the behest of religious concerns is insidious and likely unconstitutional. It would increase confusion over the role of the FDA, and lead to lawsuits.