The Pharmaceutical Research and Manufacturers of America's revised guidelines for direct-to-consumer advertising steer clear of the Internet, even as drug ads are a growing presence on the Web.

In avoiding mention of the Web, PhRMA seems to be taking the same approach as FDA, which has not issued any guidelines about that venue. The agency, instead, allows firms to proceed at their own risk in the ever-evolving space.

"The Principles apply to TV and print specifically, though we do think companies tend to use them as a guide when considering their efforts on the Internet," PhRMA general counsel Diane Bieri said in an interview. PhRMA's revised voluntary Guiding Principles, released Dec. 10 and effective March 2, 2009, add meat to some of the original recommendations and include three new ones (see ¹ Also see "Social Networking Sites: Small Step For Firms, Giant Leap For Research" - Pink Sheet, 15 December, 2008. ).

Usually, FDA treats online promotion as it would for broadcast in cases where volatile material is detected. Earlier this year, the agency issued a warning letter for an online video clip for Pfizer's Viagra , as well as a YouTube video for Shire's Adderrall XR ("² Also see "FDA’s Advertising Enforcement Turns Its Focus To YouTube, ADHD Drugs" - Pink Sheet, 6 October, 2008. p. 12).

As with PhRMA's original principles, issued in 2005, some firms have already announced plans to exceed the new benchmarks. "At this point, the standards we apply to TV and print [ads] are very much transferable to what we're doing in the online space," AstraZeneca said.

The firm said it has already adopted many of the measures included in the new guidelines, such as policies for patient and disease education. "We already solicit input on ads before we ever air them," though the process differs on a brand-to-brand basis.

AstraZeneca said it also makes ad campaigns "available for viewing via a website to ensure all of the health care professionals we have a relationship with have access to the consumer advertising prior to airing."

Firms will need to take hold of the Internet, and other forms of new media, to save costs and keep advertising afloat in a changing climate that continues to see the impact of broadcast and print ads dwindle (³ Also see "New Media Is The New Frontier For Drug Promotion" - Pink Sheet, 17 November, 2008., p. 14).

And even though the Internet is technically outside the bounds of PhRMA's Guiding Principles, the venue would seem well suited for what companies are hoping to accomplish with the principles - maximizing the educational impact of the ads without annoying anybody who does not want to be reached by the messages.

Those dynamics are increasingly driving drug advertising onto the Web. eMarketer, a digital marketing and media research site, projects that pharma will account for 5 percent, or $2.2 billion, of overall Internet ad spending by 2011.

The site predicts that Internet ad spending by drug firms for 2008 will reach $1.2 billion, up 23 percent from the $975 million spending figures for 2007.

Celebrity Disclosure

The PhRMA code does offer a response to recent instances of controversial celebrity and physician endorsements in broadcast ads, notably Pfizer's Lipitor ad featuring artificial heart pioneer Dr. Robert Jarvik (⁴ Also see "Pfizer’s Lipitor Ad Campaign Is A Cautionary Tale For Industry" - Pink Sheet, 3 March, 2008., p. 10).

The code signals "a desire to more clearly identify these people and, in the case where actors are playing a doctor role, to clearly identify they are not really a physician," Ropes & Gray's Howard Dorfman said.

Language in the guidelines asks firms to disclose compensation for healthcare practitioners who endorse products in an ad, but not celebrities.

One possible reason for the discrepancy is that "celebrities are people [that viewers] know are being paid and, frankly, being paid very well," Dorfman offered.

"The question is: 'how they impact the message?' and I can't answer that; however, for the sake of transparency the code expects DTC advertising should not feature a celebrity endorser unless it is an accurate reflection of that endorsers' opinion or experience."

Use of celebrities in ads has been the subject of Congressional and agency investigations alike. The Federal Trade Commission announced Nov. 21 proposed revisions to its Guides Concerning the Use of Endorsements and Testimonials in Advertising; public comments are being accepted until Jan. 30, 2009.

Geared towards consumer products, FTC's proposed guideline states that in cases where an endorser's experience will likely be interpreted as representing typical result, but the advertiser cannot substantiate it as typical, the sponsor should "clearly and conspicuously disclose the generally expected performance in the depicted circumstances."

PhRMA's celebrity language is not as specific. The principles state: "Where a DTC television or print advertisement features a celebrity endorser, the endorsements should accurately reflect the opinions, findings, beliefs or experience of the endorser. Companies should maintain verification of the basis of any actual or implied endorsements made by the celebrity endorser in the DTC advertisement, including whether the endorser is or has been a user of the product if applicable."

AMA Guidelines v. PhRMA's Code

The American Medical Association also outlines principles for celebrity endorsers in its DTC guidelines. Four leading pharmas have agreed to abide by many of the AMA principles; however, the companies declined to commit to a voluntary two-year moratorium (⁵ Also see "Drug Firms To Adopt AMA Guidelines On Physicians In DTC Ads" - Pink Sheet, 23 June, 2008., p. 6).

PhRMA seems to have taken a lead from the AMA guidelines in declaring that ads should include a statement that the physician has been compensated, when appropriate, and that ads also must disclose when an actor is used to portray a doctor.

Both the AMA and PhRMA recommend furthering patient education efforts and presenting balanced risk/ benefit information in simplified language that consumers will understand. The guidelines also encourage other disease management options, such as lifestyle or diet changes.

There are several differences: the AMA suggests that more specifics about disease prevention should be included in the ads to enhance consumer education, while the PhRMA code avoids such language.

Additionally, the AMA says ads should not encourage self diagnosis, though they should identify the at-risk population. The group also takes a stance against comparative claims for a product, which the PhRMA code does not.

The types of claims that should be made in DTC ads are among the issues that could be addressed in expected Congressional legislation on DTC ads. While PhRMA's principles are intended to block legal restrictions on advertising, the incremental nature of the revisions and the chilly reaction to them on the Hill suggest that legislative action is brewing.

Adverse Reaction On The Hill

Pharma firms and their advertising industry allies were largely successful in bunting any major limits on DTC as part of the FDA safety legislation enacted last year, although firms can now be fined for violative ads.

But many of the proposals that were turned back, such as a multi-year moratorium on advertising after initial approval, will likely return in bills, and be accompanied by strictures driven by more recent controversies.

Reps. John Dingell, D-Mich., and Bart Stupak, D.-Mich., issued a response to PhRMA noting that the revised code does not promote "valid clinical outcomes studies on a drug prior to its being advertised to the general public or the inclusion of the FDA's toll-free MedWatch number in all DTC television ads."

The pair have been pressing FDA about the need for outcomes data after adverse study results for Merck/Schering's Vyotrin (⁶ Also see "FDA Changes Its Mind On Vytorin; Ads Must Note “Efficacy Limitation”" - Pink Sheet, 21 April, 2008., p. 6). The demand for a MedWatch number actually runs counter to the FDA Amendments Act, which includes compromise language instructing FDA to study whether including the number would be too distracting in TV ads.

With Rep. Henry Waxman, D-Calif., now atop the House Energy and Commerce Committee after ousting Dingell, pharma firms can expect less friendly legislation to emerge from the committee, particularly concerning a moratorium on advertising.

While Dingell has had many unpleasant things to say about DTC, he famously voted against a moratorium during the mark-up of FDAAA last year (⁷ Also see "Risk Disclosure In Drug Ads Will Be FDA’s Focus After House Defeats DTC Ban" - Pink Sheet, 25 June, 2007., p. 3).

The revised PhRMA code only loosely addresses this issue. New language now states, "Companies are encouraged to consider individually setting specific periods of time, with or without exceptions, to educate health care professionals before launching a branded DTC television or print advertising campaign." (⁸ Also see "PhRMA's Revised DTC Principles Enable Firms To Set Own Moratoriums On Ads" - Pink Sheet, 10 December, 2008.).

- Carlene Olsen (c.olsen@elsevier.com)

PhRMA’s Revised DTC Code Shies Away From Internet; Not Celebrities

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