Advising the Feds
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The long turnaround time on advertising reviews, however, adds a new complication to the process of developing marketing plans,
pointed out Wayne Pines of APCO Worldwide. DDMAC puts launch materials, DTC ads, risk-management plans, and accelerated-approval
products at the top of its review priority list; conversely, something like a new sales aid can take weeks to get any attention.
Delays create particularly acute problems for companies bringing new products to market. DDMAC usually doesn't begin looking
at marketing materials for new drugs until CDER approves final labeling, and this often is the last thing decided in the NDA
review process.
Waiting for New Rules
The flood of promotional materials makes it difficult for DDMAC staff to develop the many new guidances and rules on its to-do
list. The agency received more than 1,200 comments on how FDA should regulate DTC advertising following a public hearing in
November 2005. But officials have yet to decide if FDA needs to revise its advertising regulations, issue additional guidance,
or leave things the way they are.
Another long-discussed topic is how FDA should revise its requirements for a "brief summary" of prescribing information. FDA
held a public meeting on the issue three years ago and issued draft guidance in January 2004. Then it decided to do more research
on how brief summaries are actually used andwhat options were available for improving their format and content. DDMAC is just
now launching a survey to find out which sections of brief summaries are most useful to consumers. Additional studies will
seek public opinions on ways to design and write this information to make it more comprehensible.
Regulating Risks
One new guidance that might appear sooner, rather than later, will advise marketers on appropriate ways to present risk information.
Abrams said this is a high-priority area because marketers continue to push the envelope in emphasizing benefits and minimizing
risks. FDA is struggling to bring compliance to this area, Abrams commented, pointing to the prevalence of warning letters
that cite pharmaceutical marketers for misleading presentation of safety issues and warnings in promotional materials.
DDMAC is issuing more warning letters overall (13 in recent months compared with five in comparable previous periods). And
where warning letters were traditionally outnumbered by less serious "untitled letters," the reverse is now true. Marketers
have been cited for overstating drug effectiveness and making misleading comparative claims, but the top concern is understating
risk.
Recent warning letters, for example, cite failures to explain the serious risks of diabetes and other complications related
to anti-psychotic drugs and to describe the potential for serious side effects from a new varicose-vein injection. The new
draft guidance, which Abrams hopes will be out by year-end, aims to prompt marketers of all FDA medical products to pay the
same attention to risk information as to benefits.
Jill Wechsler is Pharm Exec's Washington correspondent. She can be reached at
jwechsler@advanstar.com
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