Consultation

When necessary, there are a variety of different consults that are obtained within the Center regarding prescription drug advertising and promotional labeling issues:

• Direct-to-Consumer Advertising Consult

Advertising directed to consumers must meet the same requirements as promotion directed to health professionals. Drug application reviewers may send direct-to-consumer (DTC) advertising pieces to the DDMAC consultant on DTC issues to ensure consistency in applying the regulations to this type of advertising. DTC advertisements are often printed in popular magazines and journals that are read by a broad audience.

• Pharmacoeconomics/Managed Care Consult

Consults for pharmacoeconomic and managed care issues may be sent to the epidemiologist in DDMAC to determine whether related claims meet the requirements of the regulations. Pharmacoeconomics refers to the measurement of the costs and effects of pharmaceuticals in terms of price, cost-effectiveness and other cost ratios, and quality of life.

• Medical Consult

DDMAC reviewers work closely with medical review staff when evaluating scientific claims used in promotional materials and contact the medical staff regarding scientific questions about products.

• Statistical Consult

DDMAC reviewers may ask CDER statisticians to provide a consult on issues requiring statistical interpretation.