The biggest buzz at the Healthcare Convention & Exhibitors Association annual meeting in Toronto was, not surprisingly, the potential impact of the new voluntary ethical code issued by the Pharmaceutical Research and Manufacturers of America (PhRMA), which went into effect on July 1, just a week or so after the June 22 to 25 meeting.
To address those concerns, Timothy Casady, deputy general counsel, Eli Lilly and Co., gave a special presentation on PhRMA's Code on Interactions with Healthcare Professionals before a packed crowd of pharmaceutical company and association planners full of questions. The nine-point code covers many of the same issues as the current American Medical Association and Accreditation Council for CME () guidelines, including informational events, gifts to doctors, and the independence of accredited continuing medical education.
“If we didn't take the lead, Congress would have done it for us,” said Casady, citing media pressure, recent kickback scandals, and the overall industry environment. Still, he said, “it is not a retreat from the industry's basic business model,” which has pharma money going directly to the meeting sponsor, who controls content andto ensure the education is unbiased. It does, however, call for some significant rollback in pharma spending on social events, which now must be “modest,” and disallows pharma companies from paying for spouse attendance, which many think will drop attendance at these events dramatically.
Outside of his session, some planners said they thought the new code, which replaces PhRMA's decade-old original ethical code, may just be a correction, which many noted happens cyclically about every 10 years. “Things'll tighten up for a while, then relax,” said one pharma planner. “By 2012, we'll probably need a new set of rules to rein things in again.” Others said they believed the tightened rules are here to stay — at least until there is no more risk of a TV show's crew skulking undercover at a pharma-supported reception.
While the code has to be voluntary due to antitrust issues, pharma CEO involvement in the drafting of the code would seem to ensure that compliance will be high on their to-do list. Still, Casady said, there are still many gray areas, such as how the code should be applied to non-U.S.-affiliated pharma companies, and what titles are covered under “health care provider”; e.g., if the doctor's spouse is also the office manager, is it OK for the spouse to attend a social event? The bottom line is that you must appear to be making a good-faith effort to follow the spirit of the code, even if it's not spelled out explicitly. “If you really believe in the code, you'll bend over backwards to make your meetings compliant,” he said.
In the meantime, where will that money not being spent on lavish parties go? Most HCEA attendees seemed to think it would be plowed back into CME, which brought smiles to the medical society planners. But Casady brought down the house when he answered, “To consultants paid to train people about the new code!”
FDA Enforcement on the Agenda
Lucy Rose, president, Lucy Rose & Associates, Leesburg, Va.; former director of the Office of Training and Communications, Center for Drug Evaluation and Research; and former head of the Division of Drug Marketing, Advertising, and Communications with the FDA gave a well-received presentation on current FDA enforcement efforts.
Increased concern over drug safety and pricing, the link between pricing and promotional spend, and legal considerations that fall outside of the FDA's rule — such as bribes and kickbacks, product liability issues, and antitrust concerns — all contributed to a flurry of increased FDA enforcement issues last summer, including double the usual number of untitled letters sent to companies it found to be noncompliant at shows, including the American Society of Clinical Oncology's annual meeting (see “FDA Cracks Down on Exhibitors,” MM September/October 2001, page 36).
Rose said there were lessons to be learned from last summer's activities. “Pay attention to CFR 312.7(a), the rules that prohibit promoting an investigational drug,” she said. “You can't draw safety or efficacy conclusions before the drug is approved.” But it is a slippery slope, because the regulation also says that the FDA cannot stand in the way of the “free exchange of scientific information.”
Pharma medical information staff can discuss off-label use only when the request for information is unsolicited — that means reps can't wear “Ask Me About” buttons or build a yellow brick road from a session to their booth, she said.
But there still are gray areas. Is a scientific booth that explains a drug mechanism in itself a prompt for questions, because docs are likely to ask if they have a new drug coming out in that area? How much fair balance does there need to be on exhibit booth panels? How comprehensive does a booth's “cone of silence” (a secluded area used to discuss unprompted off-label uses in private) need to be? Current regulations don't provide guidance in these areas, but Rose advised attendees to err on the side of caution, and to make a good-faith effort to do the right thing.
“The two biggest issues on the FDA's mind right now are expanding indications and minimized safety. It may feel like it, but the FDA really isn't in the sales-suppression business,” Rose said.