The Food and Drug Administration (FDA) wants to overhaul its process for regulating over-the-counter medicines, saying the decades-old system is flawed and grossly outdated. A two-day meeting among drug regulators is planned next month to discuss a modern-day alternative.
The current monograph was established in 1972 as a way to set dosing, labeling and other standards for nonprescription drug ingredients, from aspirin to anti-bacterial soaps. But the process is slow and laborious, requiring scientific reviews, public hearings and comments before a final monograph is published, resulting in a review backlog of many common pain relievers. It also stalls the addition of warning labels and emerging safety risks on nonprescription drug products.
The review process has come under attack by scientists, consumer groups and even members of Congress, who say it is time the system is updated in order to address new safety issues with the speed and agility that is necessary to serve the public.
For example, it took 35 years – and a three-year court battle with the environmental group National Resources Defense Council – for the FDA to resume its review of common anti-bacterial soap cleansers and finally announce that there was no evidence that they were more effective than regular soap.
The FDA said it wants to design a new system that will allow the agency to respond promptly to safety and efficacy concerns as well as allow room for innovative changes to drug products.
However, the Consumer Healthcare Products Association, the leading industry group representing companies such as Johnson & Johnson, Bayer and Procter & Gamble, says it does not support an overhaul of the nonprescription drug product review process.
“The system ensures consumers have access to a wide variety of safe and effective medicines, while at the same time providing the FDA with access to important information on safety and quality,” said Elizabeth Funderburk, the group’s spokesperson.