FDA Ad Letters Focus On Superiority Claims; Oversight Critiqued On Several Fronts
Executive Summary
FDA appears to have shifted the focus of its advertising oversight and is concentrating on superiority claims as opposed to safety issues; the agency also seems to have relaxed the tone of its enforcement, relying more on "untitled" letters than it has in the past
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FDA appears to have shifted the focus of its advertising oversight and is concentrating on superiority claims as opposed to safety issues; the agency also seems to have relaxed the tone of its enforcement, relying more on "untitled" letters than it has in the past. While the agency appears to be on track to send roughly the same number of citation letters this year as last, they are evenly split between warning and "untitled" letters, while 2006 saw almost twice the proportion of warning letters. Also, FDA has already issued nearly as many citations for unsubstantiated superiority claims this year as it did in 2006 (see chart: " 1 Substantial Changes On 'Substantial Evidence' Citations By FDA "). The two most recent letters released by FDA illustrate the trend: Novartis received a warning letter for a professional file card touting its Alzheimer's medication Exelon (rivastigmine) over Pfizer's Aricept (donepezil) and Pfizer was cited for a journal ad claiming advantages for its antipsychotic Geodon (ziprasidone) claims over generic haloperidol. [Editor's note: In-depth coverage of the Exelon and Geodon letters appeared in 2 "The Pink Sheet" DAILY . To read the articles and sign up for a free trial, visit our website, www.ThePinkSheetDAILY.com.] As FDA's enforcement pattern changes, the agency continues to face two fronts of criticism over its ability to regulate manufacturer advertising practices. At issue is whether the agency is extending too far into regulating manufacturer advertising or if the advertising division can keep pace with the rapid growth of promotional spending. An Aug. 16 article in the New England Journal of Medicine suggests that FDA's regulatory action pales in comparison to promotional spending, particularly direct-to-consumer advertising. Spending on DTC advertising grew at an average annual rate of 14.3 percent from 2002 to 2005, according to the article. "FDA's capacity to enforce advertising regulations has weakened in recent years," the article states. The study attributes FDA's diminished capabilities partly to the 2002 requirement that all regulatory letters be approved by FDA's Office of Chief Counsel and the static growth of staff members dedicated to reviewing advertisements. In an interview with "The Pink Sheet," University of Pittsburgh's Julie Donohue, the study's lead author, recommends congressional action, but is hesitant about relying on user fees to fund advertising reviews. "I would say that in the best of all possible worlds, Congress would increase funding ... but if that doesn't happen and user fees are the only way, then it is better than the current situation," she said. The renewal of the drug user fee act will create a new, voluntary user fee system under which companies can submit DTC ads for prior review by the agency. The House Appropriations Committee recently displayed its own reservations about user fees when it attempted to block DTC user fees from the Prescription Drug User Fee Act, replacing $6.2 million in appropriations for part of the $459 million recommended by the Senate to be collected in user fees in FY '08 (3 (Also see "DTC User Fees Rejected By House Approps Panel As FDA Safety Funds Get Boost" - Pink Sheet, 23 Jul, 2007.) p. 14). The free enterprise advocacy group Washington Legal Foundation finds no solace in congressional appropriations for FDA, because they find that the warning letters overreach their regulatory boundaries. In an Aug. 10 article published for the group, former FDA Associate Chief Counsel and current Pfizer Senior Corporate Counsel Arnold Friede recommends companies provide "substantial evidence" for all promotional claims, because FDA "doesn't really care" about other supporting evidence. In 2005, WLF launched "DDMAC Watch" which criticizes letters from FDA's Division of Drug Marketing, Advertising and Communications that the organization feels inappropriately restrict companies promotional activities (4 (Also see "WLF Questions Ad Division Allegations; “DDMAC Watch” Starts With Strattera" - Pink Sheet, 27 Jun, 2005.), p. 21). The group is hoping to build a legal case against FDA's advertising activities, much in the same way WLF challenged the agency's limits on off-label dissemination. DDMAC Director Thomas Abrams attributed the number of warning letters sent in recent years to aggressive promotion that "pushes the envelope" (5 'The Pink Sheet' March 5, 2007, In Brief). The 6 WLF 'legal backgrounder' outlines the group's objection to the "substantial evidence" criteria that FDA uses to evaluate promotional claims, which essentially means that firms should not make statements that are not in a product's labeling. "The underlying statute does not expressly provide for a 'substantial evidence' standard for promotional claims for drugs," Friede states. "That standard has been engrafted by FDA from the approval context to the advertising substantiation context." - Daniel Poppy ([email protected]) |