This language was inserted in favor tougher wording that, originally, would have given the FDA authority to block a drugmaker from advertising a med that carried serious safety concerns. But that was removed over constitutional concerns. Now, though, some lawyers tell FDALegislativeWatch that the softer provision may also have trouble passing constitutional muster. The FDA's authority "likely will be tested at some point in the courts," David Ogden of WilmerHale tells the newsletter (subscription required).
He contends that delay airing an ad for 45 days to allow a pre-broadcast review appears to be "classic prior restraint" of speech, and pointed to the commercial speech doctrine as the basis for a court challenge. This legal theory maintains that government restrictions on commercial speech must serve a substantial government interest, be no more restrictive than needed, and are invalid if there is a clear alternative that is less intrusive, the newsletter notes. Such a battle will likely be more interesting to watch than most DTC ads.