AstraZeneca proposed on Tuesday a mandatory requirement for pharmaceutical companies to submit all direct-to-consumer advertising to the U.S. Food and Drug Administration's (FDA) Division of Drug Marketing and Communication 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.

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 FDA today also announced that all drug manufacturers will have to submit the drug label information to FDA in a new electronic format.

This electronic format will allow healthcare providers and the general public to more easily access the product information found in the FDA-approved package inserts ("labels") for all approved medicines in the United States.

These new electronic product labels will be the key element and primary source of medication information for "DailyMed", a new interagency online health information clearinghouse that will provide the most up-to-date medication information free to consumers, healthcare providers and healthcare information providers.