The FDA has stepped up efforts to combat what it sees as the No. 1 pharmaceutical marketing compliance problem: ads that omit or downplay risk information.
Last year the agency sent out 14 warning letters to drug marketers, one less than its total in 2005. Previously the yearly average was four to five. Among reasons cited for the enforcement boost: marketing departments more often are “pushing the envelope” and stressing drug benefits but not presenting adequate risk information, said Thomas Abrams, chief of FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC).
In those cases during 2005 and 2006 when prescription drug advertising pushed the envelope too far, the leading violation was omission or minimization of risk information, Abrams told a crowd of about 225 pharmaceutical regulatory professionals at last Wednesday’s Drug Information Association (DIA) meeting in New York City.
The same holds true of ads promoting biotechnology products, reported Elenita Ibarra Pratt, who heads FDA’s Advertising and Promotional Labeling Branch (APLB), the biotech counterpart to DDMAC.
“There appears to be a lack of attention on risk information, as the focus is so much on benefit,” Abrams said. “Many people…are devoted to the marketing strategy of selling the drug by refining the benefit message. I think we need to put more of this expertise into the presentation of risk information in promotion.”
While more drug firms are engaging in aggressive promotion, Abrams said that instances of stressing efficacy at the expense of risk are “not many cases at all.” Nevertheless, “This is not in the public interest and is short-sighted when it does happen.”
Of the 14 warning letters DDMAC sent last year, one cited a consumer-directed piece (for GlaxoSmithKline herpes drug Zovirax); the others were for promotional pieces directed to healthcare professionals.
This type of violation is occurring despite last year’s issuance of the PhRMA Guiding Principles on DTC. Among other things, the voluntary code encourages compliance to regulations, specifically that promotion not be false, misleading or imbalanced. It also encourages use of educational ads over reminder ads and running spots for certain drugs, such as erectile dysfunction products, during times when younger audiences typically don’t watch TV. Abrams cautioned against judging the code’s effectiveness at this point. “A year is not enough time,” he said. “We are hopeful the guiding principles will have a positive impact on DTC.”
Meanwhile, Abrams stressed that Rx drug promotion should be a vehicle for disseminating “good risk information.” To that end, “I’m reaching out to the industry…to try and put more focus in this area,” he said.
It wasn’t the first time he made that appeal. Earlier this year, in another speech addressing compliance professionals in Washington, DC, Abrams said DDMAC is working on guidance to help industry convey risk information in promotion and address questions in this area. The guidance, he said, is due to be issued in June.
FDA has come under heightened scrutiny of late for its efforts to ensure drugs are safe as advertised. The Institute of Medicine (IOM), in a set of recommendations issued last September, said among other things that the FDA needs more resources and more regulatory authority to approve and monitor consumer promotion. Abrams addressed that concern, saying that even with the recent transition of two journal ad reviewers to the DTC side, his division’s increased workload has outpaced the resources dedicated to reviewing ads. Still, DDMAC is working up more warning letters, for reasons that also include ads promoting unapproved uses and those making unsubstantiated claims. And FDA has since proposed the establishment of an advisory committee on risk communications and the launch of a test program for post-marketing evaluation of drugs.
Also, an agreement was reached late last year in which the drug industry would provide funding for the review of TV ads by DDMAC. That provision is separate from but is being considered in conjunction with the Prescription Drug User Fee Act (PDUFA), which comes up for re-authorization every five years including 2007. At a public meeting held this month, Abrams said public comments were supportive of the TV-ad vetting idea.
Asked what he would tell drug marketers with regard to pushing the envelope, Abrams, who once worked for the drug industry, said, “I have a tremendous respect for marketing people, but let’s do the right thing. I think you can sell a drug and do it the right way.”