August 2, 2005--The Coalition for Healthcare Communication applauds PhRMA for taking a step forward today in DTC self-regulation while steadfastly supporting the First Amendment right of consumers to learn about their drug choices for better health.

The new Principles demonstrate the collective choice of the research based drug companies to continue valuable DTC campaigns aimed at patients and health professionals while pledging to exercise that right carefully and responsibly. The Coalition also recognizes that individual companies have taken even more steps to revise their DTC policies in line with their particular circumstances. These companies include J & J, BMS, GSK, Astra Zeneca and Pfizer.

In light of these recent developments, the Coalition believes that advertising policy makers on the Hill and at the FDA should avoid any additional regulation of DTC until they and the industry have experience with these new Principles.

Two aspects of the Principles are especially noteworthy because they quickly and definitively address matters largely beyond the power of the Congress or authority of the FDA and thus immediately advance the goals of both the industry and many of its critics:

First, Section 13 explicitly recognizes that the prevalence of ED ads has caused much of the public outcry for reform of DTC advertising. This principle states that both the content and placement of ads for adult products should be targeted to age appropriate audiences. In this one quick action PhRMA companies have pledged to resolve a difficult issue largely beyond the reach of Congress and the FDA because of the First Amendment limits on government actions. This is self-regulation that supercedes the power of the government, and should put much of the public concern behind us. Indeed, the PhRMA goal of confining these ads to programming where 80 percent of the audience is age 18 or older is the most stringent such restraint by an industry code.

Second, the Principles largely eliminate the use of television "Reminder Ads", those ads explicitly allowed by the FDA that feature only the names of the products, not their uses, side effects or safety information. This implicitly recognizes that despite FDA policy, some of these ads may have inadvertently led to confusion and not fully met the information needs of consumers. The Principles call for DTC ads to clearly state the use of the drug as well as all the identified major risk factors. Again, the industry has moved more quickly and nimbly than possible by the government.

Meanwhile, the Principles recognize the recent concerns about drug safety and the importance of doctor/patient discussion addressed by many who have called for a "moratorium" on DTC immediately after a drug has been approved by FDA.

The Principles strengthen the industry commitment to timely submission of new ads to the FDA, while retaining the ability in appropriate circumstances to immediately inform consumers and doctors about breakthrough drugs that can save lives and alleviate suffering.

The Principles support the FDA's new safety initiatives by encouraging more professional communication about drugs at launch by professional advertising and other means. This refocus on professional communication, especially in the context of continuing medical education and journal advertising, should lead to better informed health professionals and continuing advances in doctor/patient communication.

View the entire PhRMA "Guiding Principles" document in PDF format.