WASHINGTON Feb 21 The U.S. Food and Drug
Administration is proposing sweeping changes to its 40-year-old
system for approving over-the-counter drugs to make it quickly
adaptable to scientific changes.
The agency said in a document filed on Friday that an
examination of the system had revealed "significant challenges"
associated with the regulatory process.
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."
That is no longer the case, the agency said. Now it is
interested in hearing ideas for changes to the process "or ideas
for its replacement with an entirely new regulatory or
The document was filed to the Federal Register, the U.S.
government's official journal. The FDA has scheduled a hearing
for public comments on March 25 and March 26.
Over-the-counter drugs can be marketed under the FDA's
monograph process. A monograph describes 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.
The FDA said 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
In addition, the FDA said, there are limitations on its
ability to require new warnings or other labeling changes in a