Little Innovation In US OTC Switches For 20 Years, ACNU Won't Remove Impediments

Little Innovation In US OTC Switches For 20 Years, ACNU Won't Remove Impediments – Study

Of 45 switches since 2002, three added an indication to OTC market and three were “an exceptional innovation” offering “a genuinely novel OTC product, providing a new to OTC active pharmaceutical ingredient, pharmacological class, and indication,” Haleon researchers found.

An analysis by Haleon plc researchers is critical of the US drug industry and the Food and Drug Administration’s record for Rx-to-OTC switches during the past 20 years, finding that “an overwhelming majority” didn’t add innovative products to the consumer health care marketplace.

The analysis published earlier in June in the journal Therapeutic Innovation & Regulatory Science, which authors Matt Fisher and Kapil...