CHPA files comments to FDA regarding OTC Drug Review

WASHINGTON — The Consumer Healthcare Products Association on Friday filed comments to the Food and Drug Administration in response to the agency’s Notice of Public Hearing and Request for Comments on the Over-the-Counter Drug Monograph System, also referred to as the OTC Drug Review.

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 the FDA already has in place.

“The way over-the-counter products are currently regulated has been demonstrably effective for more than 40 years,” said Scott Melville, CHPA president and CEO. “We can improve upon it without undermining a sensible system that has served consumers well.”

In particular, CHPA offered the following suggestions for streamlining the process to promptly resolve the tentative final monographs:

  • Accelerating completion of  the tentative final monographs 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;
  • 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.
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