The FDA reps asked whether the access problem would be solved by an age restriction or the creation of a third class of pharmaceutical distribution, such as the behind-the-counter
status used in Canada and the United Kingdom.
WASHINGTON -- The Food and Drug Administration has no immediate plans to seek establishment of a new, behind-the-counter
class of drugs, officials said at a meeting on the topic in November.
Several panelists in the FDA statin hearings said they wouldn't vote for over-the-counter access but would happily go for a behind-the-counter option if one were available.
In the absence of any evidence that behind-the-counter screening increases consumer caution, some doctors see this option as little more than a way to make skittish regulators more comfortable with the transition to over-the-counter status.
And while the behind-the-counter trend seems to be moving toward easier access, it can also lurch backward.