Imagine picking up the Wall Street Journal one morning and seeing a write-up about FDA violations that occurred on your conference's show floor. It's not a far-fetched scenario — it happened to the American Society of Clinical Oncology, the American Urological Association, and the American Society of Health-System Pharmacists this summer after a crackdown on exhibitors by the FDA's Division of Drug Marketing, Advertising, and Communications. DDMAC enforces FDA rules regarding pharmaceutical promotional activities on the show floor, in print and television ads, and on the Web.
In June and July, DDMAC sent out a rash of what it calls “untitled letters” to pharma companies who exhibited at recent meetings, saying they must “cease and desist” improper promotional practices such as minimizing risks associated with off-label drugs. In just two months, a total of 12 letters were sent regarding improper promotional activity on the show floor — half the total letters sent over that time period.
“ We wanted to send a clear message that this is not acceptable.”
“This is an area that is high priority for us,” says Laurie Burke, chief of DDMAC's Evidence Review Branch. “Over the past year or so, we have noticed an explosion of improper activities in the exhibit hall, not only from our own surveillance, but from an increasing number of complaints from physicians, competitors, and other people outside of the agency.”
“We wanted to send a clear message that this is not acceptable,” adds Leah Palmer, DDMAC's senior enforcement advisor and chief of its Enforcement Branch.
While the 1998 court ruling gave exhibitors some wiggle room in promoting off-label drugs on the show floor, prescription drug manufacturers, packagers, and distributors still can't draw any conclusions about the safety or efficacy of their products, or new indications for their products, prior to FDA approvals.
They also have to show “fair balance,” meaning the promotion of the desired effects of their drugs must be balanced by warning about potential drawbacks. Companies also have to ensure that requests for information about an off-label drug are unsolicited. Burke says the FDA is developing a guidance in this area to help keep reps from prompting requests for information on off-label drugs.
Should You Be an Exhibit Floor Cop?
So how can you ensure the quality of information being disseminated on your exhibition floor isn't in violation of FDA regs? Or do you even want to try?
After all, it's not your responsibility, according to David Bloch, an attorney with Reed, Smith, Shaw & McClay in Washington, D.C. “The FDA's jurisdiction is over the manufacturers, packagers, and distributors, not meeting planners.”
Planners are held to the Accreditation Council for Continuing Medical Education Standards for Commercial Support, which govern relations between commercial supporters and CME providers. The Standards also delineate the separation of education from promotion. While they stipulate that exhibits cannot interfere with education and must be in a separate area from the programs, they do not address exhibitors' behavior on the show floor.
“No association wants to assume the responsibility for enforcing FDA's rules,” says Tony Maiorino with New York City — based Scherago International, whose clients are associations in the medical, health care, and scientific fields. “It's not possible.” It is, after all, the FDA's job — one that Palmer says is going to continue to be a priority for the agency.
However, many societies, such as the American College of Cardiology, remind exhibitors in their commercial exhibition prospectuses that there are FDA restrictions on the promotion of investigational and pre-approved drugs and devices, and that they can get that information directly from the FDA.
The American Society of Clinical Oncology says it “has strict policies in place governing annual meeting exhibitors and the floor of the exhibit hall.” ASCO says it has a committee made up of members who are dedicated to monitoring the exhibit hall and enforcing the society's policies, which are in addition to those set by federal, state, and local regulatory agencies.
“ASCO makes it clear that exhibitors are expected to be in compliance with all local, state, and FDA regulations,” says an ASCO spokesperson. “In fact, it's the very first item in ASCO's official Exhibitor Rules and Regulations.”
Yet despite these efforts, many of the letters sent out this summer from the FDA went to violative exhibitors at ASCO's annual meeting this spring.
Burke says, “We're interested in partnering with conference planners to explore ideas on how we can avoid these situations in the future.”