New Drug-Advertising Options Confound FDA Regulators

With rapid proliferation of social media and pressure growing from multiple sources, the Food and Drug Administration (FDA) turned to the public for ideas on how to regulate the advertising and promotion of prescription drugs and devices on the Internet and within online social media.

The agency held an open public hearing in Washington, D.C., on November 12 and 13 to gather comments. Speaking from vastly different perspectives, representatives from the pharmaceutical and advertising industries, Internet-technology firms, and consumer and patient advocates all urged the FDA to update its rules and adapt to the unique characteristics of online communication.

The FDA had previously considered regulations for Internet drug promotion and held a public hearing in 1996. However, it issued no specific regulatory guidelines.

The agency is grappling with regulating drug and medical-device advertising in conjunction with the dizzying speed of technological advances, particularly Web 2.0 applications and mobile technologies that are growing in popularity with the public. During the hearing, speakers from various sectors repeatedly pointed out that the Internet is fundamentally different from traditional media in that the consumer has a far more active role in searching, obtaining, and contributing to the information stream.

In the past few years, the agency's Division of Drug Marketing, Advertising, and Communication (DDMAC) has sent an increasing number of warning letters to pharmaceutical companies about online advertisements including sponsored links on search engines and YouTube videos that were considered to be violating the current rules. Many of these violations involve failing to adequately balance efficacy claims with risk information, particularly in sponsored links on search engines (Psychiatric News, June 5).

Pharmaceutical, advertising, and Internet-media companies complained that the agency's rules for direct-to-consumer (DTC) advertising are intended for traditional media and have stifled drug companies' ability to use online media in DTC marketing and disseminating information to the public. For example, the space limit of online ads or sponsored links makes it difficult, if not impossible, to present both efficacy and safety information simultaneously. Representatives from Google and Yahoo suggested at the hearing that hyperlinks, rather than plain text, should be allowed as a way to provide safety-risk information to consumers.

Consumer advocates argued that the FDA must step up monitoring and enforcement efforts to ensure that online health information and product advertisements are truthful, complete, and compliant with regulations.

So far, the pharmaceutical industry has taken a cautious approach to online advertising and use of social media. Several pharmaceutical companies have started YouTube channels featuring promotional videos and online-support forums for patients who use their products (Psychiatric News, March 20). In the past year, only 3 percent of the industry's $4.3 billion DTC advertising budget was spent on the Internet.

At the public hearing, representatives from pharmaceutical companies such as Sanofi-Aventis, Internet companies such as Google and Yahoo, and advertising and consulting firms for these industries urged the FDA to draw clear boundaries within which companies can walk without the fear of being burned.

A representative of the Pharmaceutical Research and Manufacturers of America, the drug industry's trade group, proposed that the FDA issue an online “stamp of approval”— a logo or symbol—on Web sites that are regulated by the FDA. This symbol would help consumers distinguish pharmaceutical company Web sites and FDA-approved labeling information from other sites over which the agency has no jurisdiction.

Nevertheless, it is questionable whether the DDMAC has the resources to constantly monitor all the Web sites it regulates and promptly take action against content that violates the regulations. Current regulations do not require companies to submit promotional materials for FDA review before they are disseminated to the public.

To further complicate the matter, once a company opens up its Web sites to interactive features or participates in third-party social media such as Facebook, Twitter, blogs, or online forums, the company may be involved in practices that may violate the prohibition against making off-label claims. For example, online users unaffiliated with the company may discuss off-label use of certain products on a company's virtual community, or a company may advertise on a third-party Web site that posts inaccurate information or off-label claims about FDA-regulated products. In these situations, the company's obligations and liabilities remain unclear.

The agency says it will continue to accept public comments on this matter until February 28, 2010. Written comments can be submitted by mail or electronically to the Division of Dockets Management at the FDA under the docket number FDA-2009-N-0441.

Transcripts of the public hearing and details about the open docket, including how to submit a comment, are posted at <www.regulations.gov>.