"First Amendment--what is that? The FDA believes the Bill of Rights starts with number two," quipped David G. Adams, attorney with the Venable Firm in Washington, D.C. Formerly with the Food and Drug Administration, Adams has switched camps and is now in private practice representing biomedical companies.
On that note, Adams began his analysis of the recent court ruling curtailing the FDA's power to regulate pharmaceutical and medical device companies.
He addressed the first plenary session of the American Medical Association's Ninth Annual Conference on CME Provider/Industry Collaboration, held in September in Washington, D.C. Attendees overflowed the room, crowding onto stairwells and hanging over balconies. One hundred more registrants than the AMA expected showed up--in part, to learn the ramifications of the court decision, said Dennis K. Wentz, MD, director, division of CME, AMA. (For more conference news, see story on page 17.)
For CME providers, the ruling means that
* Accredited CME programs are no longer the only legally sanctioned forum for education about off-label uses of drugs and medical devices, causing providers to worry that industry may decrease its support of CME.
* There is now a significant difference between the regulations imposed on drug companies by the FDA and those regulations that providers follow, as mandated by the. That gap has the potential to create rifts in industry/provider relations.
FDA Authority Handcuffed The July 30 decision by U.S. District Judge Royce C. Lamberth declared the FDA's regulations that prohibit drug and device companies from disseminating information about off-label uses a violation of the manufacturers' commercial speech rights.
Specifically, Lamberth stated that:
* The FDA cannot restrict drug and device manufacturers from distributing articles or books that focus on off-label uses, as long as the articles were previously published in "bona fide" journals and textbooks.
* The FDA cannot prohibit companies from suggesting content or speakers to "independent CME providers." The ruling defined independent providers as those accredited organizations that have no affiliation with pharmaceutical or device companies.
* The FDA's regulatory power is limited to examining whether materials and programs are false or misleading, and whether there is appropriate disclosure. When companies financially support programs or the distribution of published materials concerning off-label uses, the FDA may require them to disclose the companies' interest in those drugs and devices, and also to disclose that the uses under discussion have not been approved by the FDA.
The 1994 lawsuit against the FDA had been brought by the Washington Legal Foundation, a nonprofit organization that fights government regulators and works to protect free and commercial speech rights.
The FDA's Next Move Adams reminded attendees that the case is far from closed. "[The ruling] is a first opinion by one district court judge. The process could take years," he said. If the FDA appeals, which Adams predicted it would, the case could go all the way to the Supreme Court.
The FDA has already filed motions for clarification, asking the court if its ruling applies to the FDA Modification Act, or FDAMA. Passed last year by Congress, FDAMA addressed regulations on distributing books and articles about off-label uses of drugs or devices. There are two major differences between FDAMA and the court ruling, Adams explained.
* Under FDAMA, when a company distributes materials about off-label uses, it must show commitment to getting the product use approved by filing with the FDA for a change in labeling. Under the court ruling, the company does not have to file.
* Before disseminating materials about off-label uses, companies must submit those materials to the FDA for approval. There is no such approval process required by the court ruling.
As a result, the court ruling puts the FDA in a "significant quandary," says Adams. "Congress says, regulate. The court says the regulation is unconstitutional."
Show Me the Money! Since companies now have other options for promoting off-label uses, will they decrease their financial support of CME?
The resounding answer from Adams and from a panel of CME experts representing various sides of the industry was "No." Quite the opposite--they saw the situation as having a positive impact.
"From my point of view, and [from the point of view of] those in industry with whom I have spoken, we see the situation as net positive," said Frederic S. Wilson, manager of CME, Procter & Gamble Company in Cincinnati and chair of the Pharmaceutical Alliance for CME. "Many, perhaps most of us, in industry who enjoy collaborative relationships with CME providers, will be increasing support for CME."
But the ruling could put nonaccredited providers at a disadvantage, Adams pointed out. By allowing device and drug companies to suggest speakers and content at accredited programs, the court "essentially provided a blessing of sorts to accredited programs," Adams said. "If anyone is paying any attention at all," he said, referring to commercial supporters, "they will move in that direction."
Show Me the Speakers? Speaking of suggesting speakers--attendees expressed concern about that very aspect of the ruling. Content and speakers will now be subjects forbetween companies and the accredited providers, Adams stressed. The FDA will get involved only if disclosures are not made, or the content is false or misleading. In other words, he said, "it would have to be pretty bad before the FDA would get involved."
That leaves providers without the double backup of the FDA and the ACCME. Although commercial supporters still must follow ACCME regulations, some providers fear the ruling will lessen their clout.
Will this decision by the court have "the unintended consequence of relaxing some of our requirements?" asked panelist Konrad C. Retz, PhD, director, department of education, American Osteopathic Association in Chicago.
Pharmaceutical companies may, in fact, push for such softening of the rules. "If the court's opinion is upheld, the ACCME needs to look to its guidelines to get a more realistic approach," answered Harvey Sussman, counsel, Bristol-Myers Squibb Co. in Plainsboro, N.J. "Can the ACCME open itself up to amending of its rules?"
To parry that thrust, Murray Kopelow, MD, executive director of the ACCME, came forward to take the mike, garnering appreciative applause from the audience.
"We don't have to change our policies," he asserted. "If you read the Standards for Commercial Support, [it says] that we will engage with people who have ideas, [but] we will make our independent decisions as providers. We are a facilitating organization--not a set of barriers."
The audience broke into hearty applause as Kopelow concluded, "I think we've got a real good set of rules, and they look like they're going to work."
Show Me theRegardless of the standards, some drug and device companies are already reacting to the ruling by backing off from signing letters of agreement, say providers.
"The trend away from written agreements will probably be exacerbated," predicted Adams, adding that his advice to his industry clients is to "sit back and think about whether there is a good reason to do one."
That statement prompted Claudia D. Stravato, director, professional education, University of Texas Southwestern Medical Center in Dallas, to take the mike. "The ACCME currently requires letters of agreement," she pointed out. "Why are you already recommending to your clients that they have some choice? Are you not honoring current ACCME rules?" she demanded of Adams.
Adams clarified that he was referring to situations where his clients were working with nonaccredited providers. But then he added, seeming to equivocate, that the ruling "opens the matter up to negotiation."
It is precisely that crack in the door that is making providers edgy. A world without required letters of agreement would be the "ultimate laissez-faire environment," said Stravato. "It would be chaotic for providers. There is really no way on a practical level not to operate with those, just from a budgetary point of view."
Providers on the panel emphasized that they would continue their current policies of requiring letters of agreement. "We will continue to insist on some kind of written agreement," said Shelley L. Hicks, assistant vice president, special projects, American Academy of Physicians Assistants, Alexandria, Va.
The End of Scientific Exhibits? Prior to the court decision, the FDA did not permit any mention of off-label uses on the exhibit floor. It did, however, permit what it called a scientific exhibit area, where, for example, a pharmaceutical company could present information on off-label uses, providing it had an application pending with the FDA to change the drug's labeling.
Two years ago, the American Academy of Neurology (AAN) started just such a scientific exhibit in response to industry requests. "Our members really like it," said Glenna L. Case, PhD, AAN's director, division of education. "But I sort of feel nervous about it now," she said. "Are the rules now all overthrown? Are organizations that do annual meetings with exhibits going to be pressured to permit discussion of unapproved uses of medications on the exhibit floor? Will we see the disappearance of the scientific exhibit?"
While Adams couldn't predict all the fallout, he did say that now exhibitors can disseminate materials about off-label uses, as long as they fall under the categories the court delineated: peer-reviewed articles and reference textbooks published by an independent publisher.
So CME providers must now enforce ACCME rules on the exhibit floor, without the backup of the FDA. But that enforcement will be carried out just as it has been in the past, said panelist Marcia J. Jackson, PhD, associate executive vice president, education, American College of Cardiology in Bethesda, Md. "We have contracts with every exhibitor, laying out our rules and regulations," she said. "Our police look more to violations of our rules."
Providers--The Only Police on the Job While Adams and other experts were able to provide some answers to providers' questions about the court ruling, providers expressed the sense that they now are traveling into uncharted territory, despite the ACCME standards. "I don't know where we stand with the FDA anymore," said one specialty society representative provider during a breakout session. "Would it be appropriate to ask the Task Force to interpret this new ruling on a practical basis?"
Whatever the interpretations, providers anticipate that the ruling will lead to "more heavy confrontation," with commercial supporters, as one CME provider put it.
But the long-term results remain to be seen. Sounding a positive note, Jackson encouraged attendees to build on the partnerships that currently exist between industry and providers. "My experience over the last six years [shows] that it is very important to specialty societies to maintain their reputations for scientific objectivity, integrity, and independence," she said. "In fact, that's also important to the pharmaceutical and device companies we work with. They are eager to work with us to preserve that [integrity]."
Nevertheless, the full, weighty burden of maintaining standards falls on providers. The ruling strengthens the role of accreditation, said Wentz in an interview following the conference. "[Providers] have to do the right thing," he said. "They have to stand up to their responsibilities."
Well, what kind of jokes do you expect at a health care education conference? "Unsafe CME" was the term coined at the American Medical Association's Ninth Annual Conference on CME Provider/Industry Collaboration, during a breakout session for specialty society providers. It refers to CME on the Internet--unsafe in the opinion of some providers because there are no clear rules about how to apply ACCME and FDA guidelines to virtual education.
Abstinence isn't an option. Drug and device companies are moving aggressively into the Internet education arena. "We all have fewer dollars to spend, including on CME," said George B. Abercrombie, senior vice president, commercial operations, Glaxo Wellcome Inc. in Research Triangle Park, N.C., speaking at the conference's third plenary session. "The Internet stretches our resources." He noted that a live meeting that attracts 300 attendees costs about $110,000 to put on, whereas a virtual meeting that reaches 50,000 physicians costs about $150,000.
Where's the Protection? The first questions about CME on the Internet came up during the plenary session addressing the recent court ruling restricting the FDA's authority over drug and device companies. "In the court's mind, CME programs involve people standing around giving speeches and presenting papers, [but] I think the logic of the court's opinion will apply to those [virtual] programs," said David G. Adams, attorney with the Venable Firm in Washington, D.C.
As for the FDA, it has not yet ruled on Internet CME, said Jack E. Angel, representing the Coalition for Healthcare Communication. But, he said, "I agree with David [Adams]. You don't treat this any differently than any other medium."
So far, the ACCME has not made any specific rulings about the Internet but is treating it like any other delivery system, such as live activities or enduring materials, according to Murray Kopelow, MD, executive director, ACCME. "We are hoping to have a simple approach," he said. "But it isn't simplistic. We wrote good rules originally; they should be generalizable."
That answer didn't satisfy some attendees, who pressed for specifics. "It is important to have guidelines, rather than go through muddy waters and find out [what you did] was wrong," countered one delegate.
Kopelow put the onus back on providers. "I'd like people to talk about it and try it and see ways they would like it to be," he said. "We are prepared to listen, and then act."
No way, said some specialty society providers, who expressed their Internet angst during a breakout session. "It's unrealistic to think we will risk our accreditation by experimenting on the Internet," one attendee said. Another member voiced concern about the financial risks. "Before I spend $1 million, I'd like to know what I can do."
Get Creative Others saw Kopelow's wait-and-see attitude as an opportunity rather than a mine field. "I'm going to be creative," said one provider, "and ask for forgiveness, not for permission."