The eyes of the people in the audience at the opening general session of the the 7th Annual Pharmaceutical Meeting Management Forum got bigger and bigger as Thomas Forrester, who at the time was U.S. Corporate Compliance Officer, sanofi-aventis, detailed the consequences of not complying with today’s regulations—from enormous fines to criminal penalties for company execs. As more than one person remarked afterward, “Now that was scary!”
Fortunately, Forrester, who currently is vice president, U.S. legal affairs, and general counsel at Lundbeck Inc., also provided some best practices meeting planners can employ to keep their meetings in compliance, their companies from being fined and penalized, and their executives from being thrown in jail. The forum, which was held March 27–29 in Philadelphia, was co-sponsored by Medical Meetings and The Center for Business Intelligence.
Regs to watch
Forrester said meeting planners need to understand the “one purpose” phrasing in the Antikickback Statute of the Medicare and Medicaid Patient Protection Act. This section says that anyone who offers, pays, requests, or accepts anything of value, either directly or indirectly, to a person or entity with the “one purpose” of getting that person or organization to purchase, prescribe, or recommend formulary placement of an item reimbursed by Medicare, Medicaid, or another federal healthcare program would receive a criminal penalty. The stickiest part, he said, is that the government does not have to prove that the person or entity had intended to violate the statute, or even have any knowledge of it.
The Federal Food, Drug, and Cosmetics Act, or FDCA, also is one to keep up on, as it can cause problems for those who discuss off-label uses outside of a certified continuing medical education activity, or promote a drug that is not yet approved. Another biggie is the Federal Civil False Claims Act, which says pharma cannot knowingly submit a false claim for government payment. While pharmaceutical companies typically won’t make false claims, Forrester said, they can trigger them by promoting a drug off label, which a doc then prescribes for an off-label use and receives reimbursement from the government. Whistleblowers, usually employees or former employees, can sue to the tune of millions.
The federal healthcare reform legislation also plays into all this by making it easier for whistleblowers to file suits, classifying items from Antikickback Statute violations as false claims, and tightening the Antikickback Statute requirements.
Enforcement Trends
One thing that has pharma execs really nervous, said Forrester, is the FDA’s release of its Park Prosecutions guidelines. These state that corporate officials can be convicted of misdemeanor violations of FDCA without “personally engaging in wrongdoing, or knowing about another person’s statutory violation, provided the official had the responsibility or authority to prevent or correct the FDCA violation but failed to do so.” In other words, said Forrester, “If you have a great compliance program but someone does something wrong anyway, the executive could get in trouble.” It even could serve as a basis for FDA debarment, which essentially would put the company out of business. The guidelines do include some mitigating circumstances, such as an official’s authority to correct or prevent the violation, and the violation’s actual or potential harm to the public.
The Office of the Inspector General also now can exclude individuals and entities from participating in federal health programs. According to the OIG’s Permissive Exclusion Authority, the OIG can exclude a pharma company manager who has been convicted of (or pled to) certain offenses such as FDCA misbranding violations.
This means, he said, that it can “exclude individuals based on their role in the company—which basically means you’re out of the industry.” And the OIG doesn’t have to prove that the person knew about a violation; it’s enough that the person “should have known of the conduct that formed the basis for the corporate sanction.” Another scary provision says the OIG doesn’t have to wait for the FDA or Department of Justice to convict an individual of any wrongdoing before pursuing an exclusion.
What You Can Do
The good news is that there are things meeting managers can do to lessen their companies’, and their executives’, risk.
For advisory board meetings, make sure there is a legitimate business rationale for the meeting, such as business, scientific, or medical questions that need to be answered, Forrester said. Hire only as many advisers as is absolutely necessary, and hold only as many meetings as is absolutely necessary.
It’s also important to make sure the healthcare providers you bring on board are qualified, meaning they haven’t been excluded from federal programs. You can do this by screening them against the Health and Human Services OIG List of Excluded Individuals and the General Services Adminstration List of Parties Excluded from Federal Programs.
Meeting managers also should ensure that they pay fair market value for services rendered, and make sure that travel, accommodations, and meals are “reasonable” and conducive to scientific and educational discussion. “Think optics—‘resort’ doesn’t look so good,” he said. Advisers must be there primarily to give advice—not as a reward for prescribing or to influence them on prescription or formulary decisions—and they must disclose company relationships to the committee. Keep away from providing any entertainment, don’t allow any sales professionals to become involved, and please, don’t allow any spouses to come along, no matter what the HCP says.
After the meeting, be sure to reconcile the budget, capture the advisers’ input in writing, and document how the company used that advice “so you can prove there was a business reason for the meeting.” Planners also need to track all payments and expenses for reporting. In fact, he stressed, document everything. “Keep the documents filed where you can find them,” he added, because these investigations often can come up years later.
Displays and exhibits also can be dicey, but again there are things exhibit managers can do to protect themselves and their companies. First, find out who the audience of the show will be. “The majority should be primary users, not off-label users,” Forrester said.
Make sure to use only company-approved materials, and follow the rules on meals, entertainment, giveaways, and promotional materials. Make sure all booth personnel know that everything they say should be consistent with approved written materials that have been reviewed by legal, regulatory, and medical departments.
Forrester also said that all off-label requests for information must be referred to Medical Affairs, and all discussions of
off-label uses must be unsolicited, limited in scope, include a disclosure of the current regulatory status, and include FDA-approved indications. —Sue Pelletier
Sidebar: FDA Approval Process
While it’s not as hair-raising as some of the other regulations, just getting a drug through development and Food and Drug Administration approval is a long and arduous process, said David Townson, PhD, PMP, senior vice president, Development, MannKind Corp. Fewer than 1 percent of the compounds initiated ever get out of the lab, and for those that do, it can take 12 years or more to get to the point where it can be submitted to the FDA for approval. Just getting a drug through the development stage can cost upward of a billion dollars, he said. And even when a compound gets to the FDA approval stage, the FDA can request more data. A third of the products submitted go through in 10 months; the rest may need another six months or so to go through additional review cycles.
What this means for meeting planners is a lot of uncertainty. “I can’t be sure when you can schedule that product launch,” Townson said. One thing you can count on, though: Once that drug gets FDA approval, the pressure will be on to launch it yesterday.
The number and type of meetings planners can expect will depend on what’s happening with your company’s pipeline, and what’s happening in each of the company’s therapeutic areas. While your company may be cutting back, remember this macro trend: industry overall held almost half a million meetings last year. —Sue Pelletier