Talking the talk of pharma – a careful balance
Ever wonder why pharmaceutical companies like AstraZeneca talk about our medicines the way we do? Or why television commercials and print advertisements have seemingly endless warnings about our medicines?
Gene Hull, AstraZeneca’s Executive Director of Promotional Regulatory Affairs, answers those questions and more in this interview in which he discusses AstraZeneca’s commitment to providing healthcare providers and patients with information about our medicines that is balanced and accurate.
What is the role of the your team?
Gene: It’s our job to make sure the materials we use internally and those we release to the public – whether it is to health care professionals or to consumers – comply with the rules and regulations the FDA issues around pharmaceutical product communications. The PRA team is comprised of people with science, pharmacy, R&D, regulatory and legal backgrounds. They bring their expertise to the review of promotional materials generated by the company to ensure they comply with applicable laws, rules and regulations.
What types of materials does your team review?
Gene: On an annual basis, the PRA team reviews nearly 10,000 pieces of promotional material, many of which are disseminated to external audiences and others that are for internal use only. These materials include items such as websites, e-mails to customers, the materials our sales representatives use when communicating to physicians about our medicines, managed markets messaging, formulary placement claims, savings cards and sales training materials.
What is your team looking for in these reviews?
Gene: The FDA regulations and guidance documents that we must take into consideration when we review promotional materials apply to written, printed and graphic materials.
So, when we review a piece of promotional material we not only must evaluate whether the written claims in the piece are consistent with the FDA-approved prescribing information, but also we must make sure that the patient population depicted in the materials is consistent with the indication for that particular medicine.
Graphics matter. We have to make sure that everything – even the pictures – lines up appropriately with the FDA-approved indication of a drug. The reviewers also ensure that the medical or scientific information discussed is accurate, truthful and not misleading, and that the piece contains fair balance.
What does fair balance mean in pharmaceutical promotions?
Gene: Fair balance means balancing risk information. As PRA professionals, we need to ensure that claims about the safety or efficacy of a product are appropriately balanced with adequate information about the risks associated with the use of the product. We want to make sure that physicians and patients are informed of the precautions, warnings, contra-indications, and the common adverse events that may be associated with these drugs.
Tell us about the side effects that you hear about in drug ads on TV. Why are they included in the commercial?
Gene: In television advertisements, you see a significant amount of time dedicated to telling consumers about side effects associated with a drug. For one, as a responsible and ethical company whose primary concern is the health and safety of patients, we believe that it is the right thing to do to inform people about side effects.
To this end, the degree of the risk information provided in television ads is reviewed by, and is the subject of discussions, with FDA before the ads are put on the air. Patient health and safety is a paramount concern at AstraZeneca. Our ultimate goal is to get an effective and compliant message to consumers that will hopefully open the door for dialogue with their health care providers.
For more information on our direct-to-consumer advertising efforts, visit us here.