DTC drug ads in the spotlight

September 15, 2006

Outlook

The AMA has once again thrust the issue of direct-to-consumer drug ads into the national spotlight.

At its annual meeting this summer, some delegates, citing a variety of sins, called for lawmakers to ban such ads outright. Others urged a middle ground, which would spell out what was acceptable in a DTC drug ad and what wasn't. In the end, the moderates prevailed, a tacit acknowledgement, in part, that more far-reaching congressional actions would never pass constitutional muster anyway.

As adopted, the new AMA policy insists that, among other things, DTC ads enhance consumer education, spell out alternative treatment options, balance benefits and risks, discourage self-diagnosis and self-treatment, and alert consumers whenever actors portray doctors or real doctors are paid for their endorsements. The policy also sets out one more major guideline-"that the FDA review and pre-approve all DTC advertisements."

Calls for greater FDA involvement are undoubtedly a good thing. But the agency is already stretched thin, and nowhere more so than in its Division of Drug Marketing, Advertising, and Communications (DDMAC). With a current staff of fewer than two dozen reviewers, the DDMAC received roughly 55,000 final promotional pieces last year, about 9,300 of which fell into the DTC category. Besides these final pieces, staff must also sift through a mountain of draft promotional materials, including those that must be fast tracked for accelerated-approval drugs. In each instance, the division has had a tough time keeping up with demand, due to what FDA spokeswoman Crystal Rice calls "resource limitations." The FDA, says Rice, also anticipates "a significant increase in workload at DDMAC" as companies increase their submissions of draft TV-ads.

There have been suggestions for boosting FDA funding. California Rep. Henry Waxman, for one, has called for revising the Prescription Drug User Fee Act (PDUFA)-the 1992 federal law that authorized the FDA to collect fees from pharmaceutical makers in an effort to speed up the drug-approval process. During PDUFA's 2002 reauthorization hearings (the first was in 1997), Waxman asked that a portion of the user fees be directed to helping the FDA "ensure that direct-to-consumer ads are accurate and balanced." (This June, an AMA report made a similar suggestion, although delegates failed to adopt it as official AMA policy.)

There's a catch, though. As Waxman noted pointedly in 2002, drugmakers have been "unwilling to allow their fees to be used to ensure that their advertising is fair and truthful." The situation is no different today. Drugmakers want fee revenue reserved for the approval process.

Next year, the PDUFA is once again up for reauthorization. At this point, PhRMA refuses to comment on its ongoing talks with the FDA "until we have agreed on PDUFA reauthorization goals," said Senior VP Ken Johnson in July.

But will those goals include funds for ad reviews? If not, direct-to-consumer advertisers who want the public's trust and doctors off their backs may be pursuing a shortsighted and counterproductive strategy. There is a better way.