FDA issues draft rules for TV drug ads
By Sid Perkins
UPI Science News
WASHINGTON, Aug. 8 (UPI) -- Radio and tv prescription drug ads may soon be
more numerous, and include what the medication is sold for.
Current Food and Drug Administration regulations so constrain broadcast
advertisers that many drug advertisements simply show or mention the
product, without saying exactly what the company claims the product does.
For that, the ads refer consumers to their doctors.
That may change if the FDA's proposed guidance for broadcast prescription
drug advertisements is accepted.
Under current FDA rules, all advertisements promoting medical use of
prescription drugs must contain a "brief summary" of all important
information about the drug, including its side effects, its effectiveness,
and when it should not be taken. Also, broadcast ads must include a "major
statement" about the primary risks of taking the drug.
In practice, print ads have been able to meet this requirement by
including the risk-related sections of drug labeling in the advertisement
copy. However, providing this amount of information in broadcast ads is
difficult because of time and space constraints.
The new guidance will allow advertisers to delete the "brief summary" from
a "balanced" ad that contains side-effect information if they identify
other sources where consumers can easily obtain full product labeling.
Proposed alternate sources include toll-free telephone numbers, Internet
websites with full access to approved product labeling, direct-to-consumer
print ads that are widely available in doctors' offices and stores, or to
doctors and pharmacists.
FDA officials describe the draft guidance as a "practical approach for
broadcast advertisers." FDA spokesman Don McLearn says, "This is a
dramatic change in policy, but is in no way a loosening of the
standards."
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