GRAS always greener? FDA considers overhauling OTC monograph system

By Gareth Macdonald

- Last updated on GMT

Related tags Over-the-counter drug Pharmacology Food and drug administration

GRAS always greener? FDA considers overhauling OTC monograph system
The US FDA has given stakeholders more time to comment on the 40-year old monograph system used to regulate OTC drugs and reiterated its concerns that the approach does not allow it to keep up with new drug safety testing advances. 

According to a notice in the Federal Register, the US Food and Drug Administration (FDA) has extended the comment period until the end of July.

An Agency spokeswoman told that: “We reopened the comment period to be sure that there was adequate time for stakeholders to provide comments. There were 19 comments received during the original open comment period.”​ 

The FDA originally called for feedback on the OTC monograph system in February​ and asked interested parties whether the system needs to be revamped to make it more efficient and responsive.

According to the agency "When the OTC Monograph Process was initially established and implemented in the early 1970s, the multistep rulemaking strategy was thought to be an effective and efficient approach to reviewing large categories of active ingredients in drug products at the same time given what was the current thinking about the known science related to these ingredients.

"Indeed, the questions we are raising in this notice about the OTC Drug Review become all the more important to the public health when we compare the statutory changes that have been made to update the regulation of prescription NDA drugs to address the scientific advances in evaluating drug safety. These changes give FDA the ability to quickly obtain new information and take administrative action as needed efficiently and effectively​."

Time lines

The system is a mechanism for approving over-the-counter (OTC) drugs that does not require the manufacturer to obtain a new drug application (NDA) approval from the US.

Instead the system allows OTC drugs to be sold without prescription if they meet so called “generally recognised as safe/effective” requirements set out in standards documents – monographs –covering drug ingredients in certain types of medication.

Another problem - according to the FDA – is that producing monographs is a requiring the input of active pharmaceutical ingredient (API) review panels, agency review of the same APIs and publication of a tentative final monograph (TFM) for public comment.

Negative incentives

Only after the TFM comment period has elapsed is the final monograph issued which – combined with the fact that OTCs for which there is no monograph are allowed to stay on the market – creates several challenges according to the FDA. 

“Several significant segments of the OTC marketplace are still not covered by final monographs, and these products may lack sufficient data for FDA to determine whether they are safe, effective, or both.”

It also said that letting OTC drugs lacking monographs stay on the market put manufacturers off conducting safety studies or responding to safety concerns “as to do so may hasten a determination that their product is not GRAS/GRAE​.”

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