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OTC Monograph Process Overhaul
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The FDA held a public hearing in March 2014 to obtain input on the Over-The-Counter (OTC) Drug Review (sometimes referred to as the OTC Monograph Process, OTC Monograph, or OTC Drug Review). The Agency sought input on how to improve or alter the current OTC Monograph Process for reviewing nonprescription drugs (i.e., OTC drugs) marketed under the OTC Drug Review.
FDA is contemplating specific changes that include improving the agency's ability to quickly require new warnings or label changes as safety issues emerge based on new science. In addition, the agency said it hopes to allow innovative changes in products more quickly. It also wants to include new dosing limits for children based on the most recent science. Essentially, the FDA would like monograph drugs to have the same safety framework as prescription drugs.  The current approval framework was created in 1972 and FDA believes it needs a complete revision to become a more agile and responsive process.
Revamping the approval path would have big implications for the OTC products industry, which in 2012 recorded $29.3 billion in annual U.S. sales. The industry could introduce new forms of products more quickly as researchers discover better ingredients.
The Consumer Healthcare Products Association provided written comments to the FDA as part of the public hearing process. They offered the following suggestions for streamlining the process to promptly resolve the tentative final monographs (TFM):
  •  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.

Related Resources

CHPA Comments - OTC Monograph Process Overhaul (pdf)
FDA to Revamp Approval Path for OTC Drugs - WSJ (pdf)
Federal Register - OTC Overhaul (pdf)

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