CHPA’s comments underscored its support for the FDA’s re-examination of the system in an effort to complete the OTC Drug Review. CHPA believes this can best be accomplished by utilizing and reforming mechanisms FDA already has in place.
CHPA president and CEO Scott Melville noted that the way over-the-counter products are currently regulated has been demonstrably effective for more than 40 years.
"We can improve upon it without undermining a sensible system that has served consumers well. CHPA appreciates the opportunity to provide comments to FDA, and we are ready and willing to engage in discussions to implement improvements to the current process," Melville added.
CHPA offered the suggestions for streamlining the process to promptly resolve the tentative final monographs. The suggestions include accelerating completion of the tentative final monographs (TFMs) through clearer communication on what data/information is needed to complete them, recognizing FDA has ample authority to address emerging safety issues both within and outside of rulemaking, regardless of whether a monograph is final or tentative final.
The suggestions also include prioritizing and breaking TFMs into smaller parts to finalize what can be finalized without waiting for the whole, and accelerating completion of TFMs through a single point leader outside of Office of New Drugs.