CHPA Files Comments to FDA Regarding OTC Monograph System

Association Underscores Support for Completing Unfinished Monographs

Washington, D.C. (May 9, 2014) — The Consumer Healthcare Products Association (CHPA) today filed comments to the Food and Drug Administration (FDA) in response to the agency’s Notice of Public Hearing and Request for Comments on the Over-the-Counter (OTC) 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 FDA already has in place.

“The way over-the-counter products are currently regulated has been demonstrably effective for more than 40 years,” CHPA President and CEO Scott Melville said. “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.”

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 (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,
  •  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.

See CHPA’s full comments for more on the association’s position.

Contact: Jenni Terry 202.429.9260


The Consumer Healthcare Products Association (CHPA) is the 133-year-old trade association representing the leading manufacturers and marketers of over-the-counter (OTC) medicines and dietary supplements. Every dollar spent by consumers on OTC medicines saves the U.S. healthcare system $6-$7, contributing a total of $102 billion in savings each year. CHPA is committed to promoting the increasingly vital role of over-the-counter medicines and dietary supplements in America’s healthcare system through science, education, and advocacy.