FDA seeks input on Web ads about drugs, medical products

Article

Washington -- The U.S. Food and Drug Administration (FDA) is asking health-care providers, veterinarians included, to voice their opinions on the regulation of medical products and prescription-drug promotions on the Internet and social networking sites.

Washington

-- The U.S. Food and Drug Administration (FDA) is asking health-care providers, veterinarians included, to voice their opinions on the regulation of medical products and prescription drug promotions on the Internet and social networking sites.

Current regulations for medical products and prescription advertising don’t define what constitutes an advertisement, according to the FDA, but do state that ads must include “true statements” about the product, side effects and contraindications.

The question for the FDA is where its place should be in regulating information on the Internet about certain products and drugs, taking into consideration the fact that companies sometimes invite customers to share their reactions on sites like YouTube.

“There are no regulations that specifically address Internet promotion separately from other types of promotion … nor are there any regulations that prohibit the use of certain types of media to promote drugs and medical devices,” says the FDA.

Specific questions the FDA expects to address include identifying what online communications manufacturers, distributors and packers can be held accountable for and how regulatory requirements can be met with limited space and tools for real-time communications like microblogs (such as Twitter) and mobile technology.

FDA’s Center for Drug Evaluation and Research is working with the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health and the Center for Veterinary Medicine to get public comment. Input from patients, consumers, health-care providers and the regulated health-care industry will guide policy-making decisions on Internet and social media marketing of human and animal prescription drugs and devices, says the FDA.

A public hearing is set for Nov. 12 and 13 from 8 a.m. to 5 p.m. at the National Transportation Safety Board Conference Center, 429 L’Enfant Plaza, SW, Washington, D.C. 20594. Participants must register for the hearing by Oct. 9, but written and electronic comments will be accepted until Feb. 28, 2010.

Click hereto view the full hearing notice.

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