New FDA rule for phar­ma ad­ver­tise­ments re­quires side ef­fects to be ex­plained clear­ly

Ever no­tice how the nar­ra­tor of a drug ad­ver­tise­ment on TV can breeze through the side ef­fects in a tone that’s easy to tune out? That’s chang­ing with new rules from the FDA re­leased Mon­day that es­tab­lish more ro­bust stan­dards to en­sure bet­ter clar­i­ty around a phar­ma’s ma­jor state­ment on the side ef­fects and risks of a drug in di­rect-to-con­sumer (DTC) TV and ra­dio ads.

This fi­nal rule comes in ad­di­tion to long­stand­ing re­quire­ments that com­pa­nies in­clude such risk in­for­ma­tion in pre­scrip­tion drug ads, but in this case, the FDA and Con­gress want­ed to more ef­fec­tive­ly con­vey those risks.

More specif­i­cal­ly, the 87-page fi­nal rule in­cludes five stan­dards that help en­sure this ma­jor state­ment is pre­sent­ed in a clear, con­spic­u­ous and neu­tral man­ner. And if com­pa­nies don’t com­ply, the FDA can ren­der a drug mis­brand­ed and use civ­il mon­e­tary penal­ties to crack down.

As far as the com­ments on the pro­pos­al and how they were in­te­grat­ed in­to to­day’s fi­nal rule, the FDA said the ma­jor­i­ty, in­clud­ing in­put from in­dus­try, sup­port the rule, while on­ly a few com­ments op­pose it. Sev­er­al com­ments re­ferred to the pro­pos­al as “an im­por­tant first step,” but even more needs to be done.

“The fi­nal rule es­tab­lish­es that the in­for­ma­tion must be pre­sent­ed in con­sumer-friend­ly lan­guage and ter­mi­nol­o­gy that is read­i­ly un­der­stand­able,” the FDA said, adding:

The au­dio in­for­ma­tion in the ma­jor state­ment must be at least as un­der­stand­able as the au­dio in­for­ma­tion pre­sent­ed in the rest of the ad. In ads in TV for­mat, the in­for­ma­tion pre­sent­ed in the au­dio por­tion of the ma­jor state­ment must al­so be pre­sent­ed con­cur­rent­ly in text for a suf­fi­cient du­ra­tion to al­low it to be read eas­i­ly. In ads in TV for­mat, the in­for­ma­tion in text must be for­mat­ted such that the in­for­ma­tion can be read eas­i­ly. The ad must not in­clude au­dio or vi­su­al el­e­ments dur­ing the pre­sen­ta­tion of the ma­jor state­ment that are like­ly to in­ter­fere with com­pre­hen­sion of the ma­jor state­ment.

The changes made by the fi­nal rule come as DTC drug ads, par­tic­u­lar­ly on tele­vi­sion, have sky­rock­et­ed over the last decade.

In 2007, the FDA said the re­port­ed ex­pen­di­ture for all pre­scrip­tion drug TV ads was $2.87 bil­lion out of a to­tal of $4.77 bil­lion spent on DTC ad­ver­tis­ing. But by 2020, DTC TV ads to­taled $4.58 bil­lion out of $6.58 bil­lion spent on to­tal DTC ad­ver­tis­ing.