AstraZeneca Proposes Mandatory FDA Review Of All Pharmaceutical Direct-To-Consumer Advertising

WILMINGTON, Del., Nov. 1 /PRNewswire-FirstCall/ -- AstraZeneca , one of the world's leading pharmaceutical companies, today proposed a mandatory requirement for pharmaceutical companies to submit all direct-to-consumer (DTC) advertising to the U.S. Food and Drug Administration's (FDA) Division of Drug Marketing and Communication (DDMAC) for review prior to its use. AstraZeneca made the recommendation in written testimony submitted to FDA's Public Hearing on Consumer-Directed Promotion of Regulated Medical Products.

While already having its own set of DTC guidelines in place, AstraZeneca also adopted PhRMA's Guiding Principles on DTC Advertisements of Prescription Medicine in August. Reflecting those principles, television advertisements launched earlier this year for CRESTOR(R) (rosuvastatin) and NEXIUM(R) (esomeprazole magnesium) are educational in content and serious in tone. AstraZeneca also is the first company to use television to provide patient assistance information in product ads for those unable to afford their medicines.

"The PhRMA guidelines are a solid first step, but the proposals we're making today make clear that AstraZeneca views the PhRMA principles as a floor, not a ceiling," said Tony Zook, Senior Vice President, Commercial Operations, and President and CEO designate, AstraZeneca Pharmaceuticals LP. "If our collective goal is to ensure that accurate and responsible information is communicated to patients and health care providers, then manufacturers, patients, physicians and policymakers ought to welcome such a review process."

The submitted testimony asserts that while the present system and the PhRMA principles rely on voluntary pre-submission of ads, AstraZeneca would support legislation that would require a mandatory review of DTC advertisements by the FDA, but only where DDMAC has the necessary resources to conduct its review within a specific timeframe. Requiring FDA to review and comment on an advertisement prior to its use should preclude a subsequent finding by the FDA that the advertisement is misleading or inaccurate. Manufacturers would be required to incorporate the FDA's comments into the advertisement as appropriate. However, the FDA would maintain the right to halt the use of an advertisement it previously reviewed if, subsequent to the FDA's approval, new scientific or medical information came to light.

"As a leader in DTC advertising we have a responsibility to provide patients, consumers, and medical professionals accurate and balanced information," said Zook. "Communications that clearly discuss treatable conditions and available therapies are paramount to raising disease awareness, fostering the patient-doctor relationship, and helping to ensure that patients take their medicines as prescribed."

AstraZeneca bases its DTC advertising on the following principles: -- Providing consumers with accurate and clear information about our medicines and the conditions/diseases those medicines treat in a straightforward and responsible manner; -- Reminding patients of the necessity of talking with their doctor because only their doctor knows which treatment is appropriate for them; -- Providing an appropriate balance between benefit and risk information and clearly communicating such information so patients can have better-informed conversations with their doctors; -- Providing information on patient assistance programs, including Medicare Part D.

As part of its testimony, AstraZeneca discussed the importance of DTC advertising that provides education and disease awareness to consumers, including its cutting-edge "If You Were My Sister" campaign aimed at enhancing the awareness of the risk of breast cancer recurrence. In addition, AstraZeneca said it has committed to fund the first large-scale consumer research study on the use of fair balance in television commercials. Results are expected to be available to the public in early 2006. The company also requested that FDA provide further clarity and guidance to industry with regard to the development of patient-friendly brief summaries.

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of over $21.4 billion and leading positions in sales of gastrointestinal, cardiovascular, respiratory, oncology and neuroscience products. In the United States, AstraZeneca is a $9.6 billion healthcare business with more than 12,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

For more information about AstraZeneca, please visit: http://www.astrazeneca-us.com.

AstraZeneca

CONTACT: Andy Izquierdo of AstraZeneca, +1-202-350-5530,Andy.Izquierdo@Astrazeneca.com, or Carla Burigatto of AstraZeneca,+1-302-886-5953, Carla.Burigatto@AstraZeneca.com

Back to news