Executives at some of the largest pharmaceutical manufacturers are applauding a set of guidelines on direct-to-consumer advertising released July 29.
The Pharmaceutical Research and Manufacturers of America (PhRMA), a trade group supporting new drug development, says the guidelines go beyond what is required by the Food and Drug Administration (FDA).
Direct-to-consumer advertising by pharmaceutical companies began about 20 years ago and now is commonplace in magazines and newspapers, on television and elsewhere. Some advocacy groups have said the campaigns mislead consumers about a given drug's capabilities and don't clearly enough explain risks and side effects.
The PhRMA guidelines address those concerns, according to drug company executives.
"These principles will help us to do a better job in working with patients," says Karen Katen, vice chairman and president of Pfizer Human Health, a division of Pfizer Inc., and chairman of the PhRMA's Group on Affordability and Access. "Through the principles, we can improve communications about pharmaceutical risks and benefits, educate the public about prescription medicines and treatment options, enhance health awareness and motivate patients to talk with their health-care providers about their health."
The guidelines set up an Office of Accountability at PhRMA, which will receive comments from the public and health-care companies regarding direct-to-consumer advertising by the drug makers that adopt the principles. Annually, an independent panel will review the comments, analyze them and make a report to the public.
Among some of the guidelines adopting companies must follow:
- Companies should submit all direct-to-consumer television advertising to the FDA before releasing for broadcast.
- Such television ads should clearly state the condition for which the drug is used and major associated risks.
- Risks and safety information should be presented in clear, understandable language, without distraction.
- Companies should spend an appropriate amount of time to educate health professionals about new medicines or therapies before beginning their first direct-to-consumer advertising campaign.