Direct-to-Consumer Advertising: PhRMA Takes the Initiative in Self-Regulation

Professor Scott is Research Professor at the Health Law and Policy Institute, University of Houston Law Center, Tex.

In November 2005, the FDA held a public hearing on direct-to-consumer (DTC) advertising of prescription drugs, seeking input from individuals and groups most affected by DTC advertising. In the notice of hearing published in the Federal Register on September 13, 2005, the FDA posed the following questions:

1. Does current DTC promotion present the benefits and risks of using medical products in an accurate, nonmisleading, balanced, and understandable way?

2. Could changes in certain required prescription drug disclosures?the package insert for print "promotional" labeling and the brief summary for print advertisements?improve the usefulness of this information for consumers?

3. Could changes in the requirements for disclosure of certain information in broadcast advertising improve the usefulness of this information to consumers?

4. Is there a way to make information in DTC promotion of medical devices more useful to consumers?

5. As new communication technologies emerge, they create opportunities for novel approaches to DTC promotion. What issues should the agency consider with regard to the effect of these technologies on DTC promotion?

Research by the FDA and others indicates that current DTC advertising does a great job of presenting the benefits of particular drugs to consumers, but does not adequately disclose risks. For example, critics have blasted Pfizer for a Viagra ad that ran during the holiday season in the Wall Street Journal. A smiling man in the ad asks, "What are you doing on New Year's Eve?" The ad further says, "Fact: Viagra can help guys with all degrees of erectile dysfunction?from mild to severe."

Critics argued that the ad was an irresponsible promotion of unsafe sex, despite the ad's disclaimer that said "remember to protect yourself and your partner from sexually transmitted diseases."

Drug ads may also promise more than a drug can deliver. In November 2004, the FDA sent a letter to Pfizer demanding that it withdraw a TV ad that said, "Remember that guy who used to be called ?Wild Thing'?" and then declared "He's back." The FDA found that this ad "claim[s] that Viagra will provide a return to a previous level of sexual desire and activity" and noted that the "FDA is not aware of substantial evidence or substantial clinical experience demonstrating this benefit for patients who take Viagra."

Research also shows that the package inserts for drugs present information in a way that is of little use to consumers, since physicians are really the target audience for such inserts. It is clear that such information could be presented in a more consumer-friendly manner.

Some have called for an outright ban on DTC advertising, while others have sought to impose a "waiting period" of 1 year or more before allowing DTC advertising of new drugs, to give physicians time to better understand the drugs before they are bombarded by patient demands to prescribe the new drugs.

Although the FDA may ultimately adjust the regulation of DTC advertising, its history suggests that fundamental change is highly unlikely.

The FDA has considered the issue of DTC advertising for >20 years. It has sought and obtained extensive public and industry input on the issue. It has conducted useful research. Nonetheless, in the notice of hearing for the November 2005 hearing, the FDA candidly admits that "there are no regulations that specifically address consumer-directed promotional materials." Fur?ther, "since 1985 the FDA has applied the [Food Drug and Cosmetic] act and the prescription drug ad?vertising regulations to both professional and consumer-directed pro?motion." The FDA notes that the law does not "distinguish be?tween consumer and professional audiences in its requirement for disclosure of relevant risk information in prescription drug or restricted device advertising."

There is simply no consensus on the issues between the FDA and the drug industry. If the FDA were to seriously restrict DTC advertising, the industry would challenge such regulatory efforts in the courts, arguing infringement of ?their constitutional rights of commercial free speech. However, the FDA does have the authority to mandate consumer-friendly patient information, but so far it has only encouraged such an approach through "guidance" documents rather than through regulation. The difference is significant.

The FDA's Response to DTC Advertising

? In September 1983, after some companies began DTC advertising, the FDA called for a voluntary moratorium on DTC advertising. During the moratorium, the FDA conducted research and sought public input on the issue.

? In September 1985, the FDA withdrew the moratorium and decided that then-current regulations (aimed at health care professionals) provided adequate consumer protection.

? In July 1993, the FDA asked drug companies to voluntarily submit proposed DTC advertisements to the FDA for review before publication.

? In October 1995, the FDA held hearings on DTC advertising.

? In May 1996, the FDA published a notice clarifying that it had never required preclearance of DTC advertising materials.

? In August 1997, the FDA issued a "draft guidance" for industry on DTC advertising (revised in August 1999 as a final guidance).

? In February 2004, the FDA issued 3 additional "draft guidance" documents on DTC advertising, again seeking public comment.

Absent significant FDA regulation, the industry has begun its first real effort at self-regulation. Effective January 2006, most major US pharmaceutical companies, including Johnson & Johnson, Pfizer, Schering-Plough, Bristol-Myers Squibb, and Merck, have become signatories to a new set of "guiding principles" for DTC advertising promoted by the Pharma?ceutical Research and Manufacturers Association (PhRMA). In some areas, these guiding principles go well beyond what is now required by law.

Physicians will appreciate principle number 6, which provides that companies "should spend an appropriate amount of time to educate health professionals about a new medicine or a new therapeutic indication before commencing the DTC advertising campaign."

Although some would have preferred a specific moratorium of 1 year or longer, the industry rejected this approach. The principles instead suggest that companies take into account issues such as the importance of informing patients of the availability of a new drug and the complexity of the risk/benefit profile for the drug in determining an "appropriate" length of time.

The new principles also require companies to submit DTC ads to the FDA before they are released for broadcast. This principle may well be contentious. First, the FDA may not have adequate resources to review the ads in a timely manner. Also, companies may be unwilling to seek preclearance from the FDA, absent an agreement that the FDA would be bound by its own initial determination. The issue will be whether the FDA may initially approve an ad and later object to the ad based, for example, on a consumer or competitor complaint.

Some consumers have complained that ads for erectile dysfunction drugs during prime time television hours are inappropriate, and principle 13 addresses this issue by saying that ads "should be targeted to avoid audiences that are not age appropriate for the messages involved." Principle 11 provides that "risks and safety information in DTC television advertising should be presented in clear, understandable language, without distraction from the content, and in a manner that supports the responsible dialogue between patients and health care professionals." Lack of effective communication of risks in DTC advertising has been an area of much criticism, so this principle may in time provide a litmus test as to the effectiveness of the guiding principles.

PhRMA has established an "office of accountability" that will receive consumer or health care professional complaints about DTC advertising by its members. PhRMA has also agreed to issue a public report 1 year after the principles have been in effect. The report will include a discussion of complaints received and the signatory companies' responses.