A Fine Line

Is a pharma website a type of labeling, a form of advertising, or some new hybrid? The industry has used the internet as a communication channel since 1994, yet, after nearly a decade of online medical development and experimentation, none of the major regulators has decided yet-or offered any clear guidance about-what constitutes "acceptable use."

That leaves pharma companies in a sticky position. They can't very well ignore a medium used by more than 100 million people in the United States alone, especially one that's become such an important healthcare research tool. According to the Pew Internet Project's most recent study, 56 percent of online consumers use the web to seek information that heavily influences their healthcare decisions. But pharma companies risk sanctions and penalties if a regulatory organization finds them in violation of their unarticulated policies.

No Healthy People, Please: FDA cited Bristol-Myers Squibb for using misleading images of healthy men on its IFEX website for testicular cancer treatment.

What can a responsible pharma company do? The good news is that, in the absence of published regulations, they can find some guidance in court cases and in the rulings that international regulatory bodies have made during the last few years. By familiarizing themselves with those precedents, the industry has a fair chance of using the medium effectively and appropriately. This article summarizes the enforcement patterns established by both US and European regulators and offers some specific guidance for marketers seeking to steer clear of website regulatory entanglements.

FDA's Position

The agency's reluctance to define whether internet promotional activity constitutes "labeling" or "advertising" has left the door open for interpretation, potential exploitation, and legal conflict. Although a label requires "a summary of the essential scientific information needed for the safe and effective use of the drug," an advertisement need only contain the generic and brand names, formulation, and a brief summary statement discussing the product's side effects, contraindications, and clinical effectiveness.

Current FDA regulatory enforcement activity-which could, at best, be described as inconsistent-focuses on the scrutiny of written and pictorial matter displayed on websites under the standards of existing advertising guidelines. Websites created by Aventis, Bristol-Myers Squibb, Boehringer Ingelheim, Eli Lilly, GlaxoSmithKline, and Merck are among those cited by FDA for failing to meet advertising guidelines during the last two years.

The Soft approach: Aventis' www.zoomcancer.com is a good example of a balanced site that lets consumers ask for product information.

Although enforcement has been sporadic and there is no formal standard, companies can glean certain "website no-nos" from the agency's rulings. The most commonly cited violations on pharma web pages to date include

• omission of important safety data

• links to outdated product labeling

• misleading presentation of clinical data

• inclusion of unproven clinical data

• links to pages citing unapproved uses

• use of unrepresentative graphical depictions (See "No Healthy People, Please.")

• unapproved promotional materials

• display of promotional information about investigational drugs

• wording inconsistent with approved product labeling

• lack of fair balance

• inclusion of outdated clinical research

• links to third-party sites containing anecdotal stories from patients or clinical trial participants.

US Court's Position

On the legal side, the picture is somewhat clearer. Courts have established a distinction between physician education and advertising. The much-publicized case of Washington Legal Foundation v Friedman ruled that FDA "shall not in any way prohibit, restrict, sanction, or otherwise seek to limit any pharmaceutical or medical device manufacturer or any other person from disseminating or redistributing to physicians… any article or reference textbook concerning prescription drugs or medical devices previously published in a bona fide peer-reviewed professional journal, regardless of whether such article includes a significant or exclusive focus on uses of drugs or medical devices other than those approved by FDA."

Although there's been some debate about the interpretation of that ruling, most observers believe it means that pharma companies can disseminate scientific research from peer-reviewed journals online-even if the uses discussed are not approved by FDA-as long as they shield that information from consumers. Shielding can be accomplished through the use of password-protected access, a technique often deployed on key pharma-sponsored opinion leader websites. It seems logical that it would apply to pharma-sponsored CME events, both live and online, as well. In both cases, the information is targeted to physicians trained to critically evaluate scientific data, regardless of its source.

The European Experience

The situation within the European Union is complicated by the co-existence of EU legislation and country-specific laws. The broadest guideline issued by the European Commission (EC) covers the content of labels and package leaflets that accompany medicinal products (EC directive 92/27/EEC). Those requirements are very similar to FDA's. In 1992, the commission issued directive 92/28/EEC, which outlines the parameters for advertising medicinal products to professional audiences. But that guidance, amended in 1995, does little to address internet-specific issues that apply to both professional and consumer audiences. However, EC has formed a committee to examine the impact of the internet on pharmaceutical advertising, and global audiences anxiously await the committee's findings.

Although web-specific guidelines have not been established, regulators have tacitly permitted companies to display unmodified summaries of product characteristics, package leaflets, and copies of the European Public Assessments Report for the specific product. As long as the copy is not changed from the wording approved in other forms, those documents are not considered advertising. A survey of UK pharma websites reveals a huge disparity in the amount of product-specific information posted online, ranging from simple listings of product names to inclusion of all three allowable documents.

In one case, 76 members of the Association of the British Pharmaceutical Industry (ABPI) collaborate to provide comprehensive, up-to-date product information for the electronic Medicines Compendium (eMC), a central reservoir of pharma product information that consumers, healthcare professionals, and industry insiders can view freely. The majority of European pharma websites feature links to the eMC page (http://emc.vhn.net/professional) when referring to product information.

In a move that fosters a decentralized approach to regulation and delegates interpretation, implementation, and enforcement to the national level, the EC also issued a directive regarding e-commerce. Companies must initially submit to national regulatory bodies' applications for a license to market a specific product. Once the product is approved for marketing, all advertising must comply with EU directives. The enforcement of advertising rules is then the responsibility of national regulatory bodies until EC directives are adopted into EU law.

Of course, one significant difference in policy between the European Union and the United States is that DTC advertising and information regarding off-label uses is strictly prohibited in Europe. Providing off-label information to healthcare professionals both on and offline is not allowed under the EC Medicines Advertising Directive. But most member states will permit such activity if it is in response to a specific, unsolicited question.

Recent amendments to EC legislation allows consumers to access drug-related information online for HIV, diabetes, and asthma. Those conditions were chosen as test cases because the treatments do not vary greatly from one patient to another and patients with those diseases have been among the most active information seekers. The trial will allow pharma companies to promote products on their corporate websites as long as they abide by the proviso that patients request the information and not have it "pushed" to them through such techniques as e-mail and banner advertising. (See "DTC in Europe?" PE, January, 2002 and "If You've Got It, Flaunt It," PE, February, 2002.)

A good example can be seen on Aventis Pharma's www.zoomcancer.com, a French website that provides internet and personal digital assistant (PDA) subscribers with many types of clinical information, scientific papers, and news updates aimed at both healthcare professionals and consumers. (See "The Soft Approach.")

But the European public and political consensus is still unanimously and vehemently opposed to televised DTC advertisements. The majority position is that health policy should advocate prescribing according to the best evidence-based guidelines, rather than in response to media-generated patient demand. But the reality is that many European and global consumers are already privy to DTC advertising through the internet. So European legislators must acknowledge and address the situation.

Walking the Fine Line

In the current regulatory environment not much is clear. But in addition to abiding by all the "standard" regulatory cautions, pharma marketers would be well served by following these guidelines:

• Require site visitors to identify which country they're from, then provide them with only country-specific approved information and resources. A variety of technical techniques are available that will enable a single website search engine to be configured for multiple markets.

• Separate professional information from patient information using industry-standard security techniques, such as e-mail registration and authentication.

• Carefully consider the appropriate use of graphic images. Because most in-house attorneys and review bodies are text-obsessed, violations often occur in the use of imagery-an area in which they're not trained to catch problems.

• For European sites, don't "push" content via e-mail or banner-like displays.

• For US sites, be rigorous about presenting a fair balance between benefit claims and cautions.

• For all sites, employ content management tools to keep data up-to-date, particularly labeling and safety data. Many FDA citations involve missing or outdated content.

Although not a foolproof guide through the regulatory thicket, those rules should help marketers avoid snares and pitfalls until international bodies straighten out the regulatory mess.