Rx Promotion Remains Potential Political Liability, Attorneys Warn

Pharmaceutical companies should prepare for increased Congressional scrutiny of promotional activities heading into the 2002 mid-term elections, attorney John Kamp (Wiley, Rein and Faulding, Washington, D.C.) told a Drug Information Association marketing workshop.

Kamp suggested that Congress, especially those members facing re-election, will "find victims" if the healthcare legislative agenda has stalled. Kamp, the former senior VP of the American Association of Advertising Agencies, spoke during a Feb. 22 DIA workshop in New York City.

"About a year and a half from now, they're coming to the end and they haven't got a [Medicare] prescription drug bill yet and PDUFA's not re-authorized yet and the tax bills are still in the soup and we're in a recession, what do you think they're going to talk about?" Kamp asked.

"If you're out there in your gifts-to-physicians business and you're doing things that you don't want to have Sen. Kennedy [D-Mass.] asking your CEO about...because you're not so sure it will play well in the Wall Street Journal, I'd clean up your act real fast," Kamp declared.

"If you have some ads that don't tell the truth...about your product, I don't think you want to have that discussed in the Senate," Kamp said.

"People don't even know what [continuing medical education] costs," he continued. "They don't even know what's going on in CME and you don't want them to know. Or you don't want it discussed in the Wall Street Journal."

"Every time pricing becomes a major issue, promotion becomes a Congressional issue," attorney Alan Bennett (Bennett, Turner & Coleman, Washington, D.C.) agreed.

Both Bennett and Kamp noted the possibility that a change in a single seat in the Senate could give the Democrats the upper hand ahead of the elections.

"If the Democrats take the Senate in the next two years...I would be almost certain you would see hearings on the contribution of DTC advertising to pharmaceutical pricing and maybe even going beyond that to generally looking at promotional practices and how they affect pricing," Bennett said.

There are signs that FDA is already becoming more aggressive in its promotional oversight, Bennett suggested.

Asked about recent enforcement trends at FDA, Bennett said, "there is an area or two where I thought FDA may be beginning to explore again beyond its core authority."

Bennett highlighted a recent warning letter that FDA's ad division sent to a physician who conducted a series of promotional audioconferences on Pharmacia's COX-2 inhibitor Celebrex.

A separate warning letter issued to the company details a plan for disseminating corrective messages to the audiences that received the misleading messages (¹ (Also see "Celebrex GI Safety, Warfarin Claims Over Vioxx Need Corrective Letter - FDA" - Pink Sheet, 12 Feb, 2001.)).

"I suspect what [FDA] was doing was trying to set up a record that would disqualify this particular provider from doing CME in the future, having a negative reputation with the FDA," Bennett said. This might be "the beginning of a trend."

"It is unusual to send a letter to the physician directly as well as the company," Johnson & Johnson General Attorney Freddy Jimenez agreed. "My thought was that they were asserting jurisdiction over the speaker as a promotional speaker."

"A reading of the act does not limit misbranding charges to a drug company," FDA Division of Drug Marketing, Advertising & Communications Director Tom Abrams told workshop participants.

He explained that the physician's actions drawing the ad division warning letter were "not independent. It was promotional activity. And [FDA's ad division] is prepared and willing to take enforcement actions to stop these violations." The recruitment of product evangelists by drug companies to spread commercial messages was a key interest of FDA and Sen. Kennedy in 1990.

Jimenez warned companies also to pay attention to enforcement actions outside FDA.

"There is an incredible surge in enforcement in the fraud and abuse area with respect to false claims and kickbacks," Jimenez said. "You heard about the AWP and marketing the spreads. This kind of stuff often gets intertwined with FDA promotional activities."

Referring to a challenge to Genentech's growth hormone marketing, Jimenez noted that the company eventually faced a "misbranding case - an advertising case - but during the course of the investigation, there was a lot of investigation into alleged kick-backs and that type of thing. You should bear that in mind in terms of overall marketing compliance."

The San Francisco U.S. Attorney's office investigation into Genentech's promotions of human growth hormone products grew out of an anti-kickback investigation initiated by the Minnesota U.S. Attorney's office. In the promotion case, Genentech plead guilty to an FD&C Act violation for promoting its drug for children of short stature who are not growth hormone deficient and paid a $50 mil. fine in 1999.

Abrams commented on the ad division's recent enforcement actions, listing the most common violations "for the past 12 months" as lack of fair balance (43%), unsubstantiated safety and efficacy claims (39%), unsubstantiated superiority claims (18%), failure to file (15%) and promotion of unapproved uses (14%).

The increase in actions related to failure to file materials is "not because sponsors are not submitting their promotional materials," he explained. Rather, the ad division is "taking more and more actions on homemade pieces. We're taking more and more actions on sales representatives' activities and other materials that are not from the corporation home office."

Abrams also highlighted a "a significant number of actions on promotion in the commercial exhibit hall at medical meetings."

"We continue to see a significant amount of misleading and violative promotion occurring in the exhibit halls," Abrams said. "We are looking at this issue more carefully," he added.

The ad division director noted that complaints from competitors are a key trigger for enforcement actions.

"We encourage complaints," Abrams told the marketing conference. FDA receives "a lot of good information from these complaints. In fact, the last three warning letters - the thalidomide warning letter, the Diprivan warning letter, even the Celebrex warning letter - were based from complaints."

FDA's April 21 warning letter to Celgene cites Thalomid sales representatives for disseminating third-party press releases that promote off-label use of the drug for multiple myeloma (² (Also see "Celgene Thalomid Promotions For Off-Label Cancer Use Draw FDA Warning" - Pink Sheet, 1 May, 2000.)).

AstraZeneca drew a Sept. 1 letter on Diprivan after representatives made misleading, anti-generic statements at medical meetings (³ (Also see "AstraZeneca Diprivan Anti-Generic Promos Require Corrective Letter - FDA" - Pink Sheet, 11 Sep, 2000.)).

Bennett pointed out that there may be some areas of promotional oversight that could move in the opposite direction, citing the uncertainty surrounding off-label promotion in light of recent legislation and court cases.

The new FDA commissioner "will probably be subject to some pressure from the Hill and even from the Administration to take a look at this area to see if there isn't a way to permit more dissemination rather than less," Bennett predicted.

The divided Senate will help ensure that the next FDA commissioner will be a moderate Republican without a heavy political agenda, Kamp suggested.

Given the potential that the Health Committee could be chaired by Sen. Kennedy by the time an FDA nominee "has to come up for confirmation...do you think it's going to be an ideologue from the far right of the Republican party?" Kamp asked. "I don't think so."

The new commissioner "is not going to be David Kessler I," the Republican, "or David Kessler II, who was a hardcore Democrat when the Democrats were in the House," Kamp quipped. Instead, he suggested, the Bush Administration will look to the model of former Commissioner Jane Henney, MD, and select someone who is "in the middle" and whose mantra is "let's pay attention to the doctors."

Kamp believes that the Office of Management & Budget, under Director Mitch Daniels (ex-Lilly) will play a role in the final FDA selection. Daniels "might have some ideas" on who the next FDA commissioner will be, Kamp suggested. "If I were going to guess," Kamp said, "I'd want to know who Mitch Daniels thought was the best, most qualified, most respected doctor."