FDA is having a tough time overseeing promotional activities and providing timely advice on proposed advertising materials.
It now takes an average 45 to 50 days for the Division of Drug Marketing, Advertising and Communication (DDMAC) in the Center
for Drug Evaluation and Research (CDER) to review drug launch materials. Advice on planned broadcast ads can take 80 days.
Time frames like these create problems for marketers who want FDA's opinion before they revise TV commercials and brochures—and
they're a nightmare in planning launch campaigns.
Is FDA building a case for tapping user fees to support a bigger DDMAC staff? Agency officials won't admit to such a strategy,
but in the future companies may have to ante up for more timely assessment of promotional materials. Such proposals are evidently
on the negotiating agenda as the agency prepares for the renewal of the Prescription Drug User Fee Act (PDUFA) next year.
Speaking in September at the Food and Drug Law Institute (FDLI) conference on FDA advertising and promotion, DDMAC director
Tom Abrams acknowledged that it was taking a long time to review drug marketing materials. Submissions to DDMAC are up sharply,
and the mix includes a greater number of biotech products and drugs to treat complex medical conditions; promotional materials
for these sorts of products require lengthy deliberations by multiple staffers, Abrams explained. The office is also monitoring
thousands of Web sites, as well as a broad range of brochures, direct-mail pieces, and videos.
Ad reviewers at the Center for Biologics Evaluation and Research (CBER), which oversees marketing of blood products, vaccines,
and some combination products, report a similar time frame for providing advice on marketing materials. On average it takes
30 to 50 days to issue an advisory opinion on a DTC ad, reported branch chief Ele Ibarra-Pratt.
DDMAC received almost 55,000 promotional pieces in 2005, up from 40,000 in 2003. Most (about 40,000 items) were designed for
professional audiences. About 10,000 were directed to consumers, and some 6,000 involved Web sites serving both audiences.
DDMAC was asked to review 337 broadcast ads last year. That is actually about 100 fewer than in 2004, but more than previous
Are We Clear Yet?
The numbers don't tell the whole story, however. Ten years ago, few product launches involved consumer advertising, and many
submissions made just slight revisions to existing ads, explained Melissa Moncavage, leader of DDMAC's DTC review group. Today,
most DDMAC filings contain totally new materials, and biotech companies are beginning to run TV ads for complex new therapies.
DDMAC similarly received fewer requests for advice on broadcast commercials (146 proposals in 2005, compared with around 200
in previous years), but the process of providing advisory opinions is still resource-intensive. DDMAC takes a team approach,
says Moncavage, bringing in medical reviewers and other CDER officials to review consumer ads for innovative products.
DDMAC is reorganizing to add a second DTC review group to deal with this rising workload. The change adds only one new reviewer,
but the agency hopes that the presence of two group leaders —Moncavage and Christine Smith—will reduce the bottleneck on advisory
opinions. The two groups will continue to examine print ads, brochures, and physician hand-outs, in addition to TV commercials,
and to encourage marketers to seek agency advice on proposed ads. (Submission is voluntary, except for products that qualify
for accelerated approval.)