The U.S. Food and Drug Administration wants to make significant changes to its 40-year-old system for approving over-the-counter drugs to make it quickly adaptable to scientific changes, Reuters reported.

In a socument filed on Friday, the federal agency said that an examination of the system had revealed "significant challenges" associated with the regulatory process, Reuters reported.

When the OTC drug review process was established, the agency said, "it was generally thought that safety and effectiveness evaluations for the various active ingredients would be fairly straightforward and would not necessarily need continuous reexamination over time."

However, times have changed, and that is no longer the case.

Now The agency is interested in hearing ideas for changes to the process "or ideas for its replacement with an entirely new regulatory or statutory framework," Reuters reported.

The federal health regulator has scheduled a hearing for public comments on March 25 and March 26.

Over-the-counter drugs can be marketed under the health regulator's monograph process.

A monograph is used to describe the standards and conditions for marketing certain classes of OTC drugs that are generally recognized as safe and effective.  

"If an OTC drug meets the conditions contained in any given monograph, companies do not have to file a new drug application and have the product individually reviewed by the FDA," Reuters reported.

A large number of products are on the market pending finalization of monographs, meaning there may not be enough data for the FDA to determine whether they are safe or effective, according to FDA officials.

In addition, the FDA said, there are limitations on its ability to require new warnings or other labeling changes in a timely manner.