FDA Meetings to Discuss Internet Marketing of Drugs

The Food and Drug Administration is scheduled to hold two public hearings next month to gather ideas from the public and the drug industry about how to better regulate the use of the Internet and social-networking sites by drug companies to promote prescription drugs and medical devices.

The FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) announced today that it will hold public hearings on Nov. 12 and 13. Written and electronic comments will be accepted until Feb. 29, 2010.

The meetings come as more and more drug companies are turning to social-networking Web sites such as Twitter and Facebook to build hype about their products. The FDA wants to make sure that information about prescription drugs on the sites is “truthful, balanced, and accurately communicated.”

“This is accomplished through a comprehensive surveillance, enforcement and education program, and by fostering better communication of labeling and promotional information to both healthcare professionals and consumers,” the FDA said.

The fast-evolving world of Internet-based marketing and promotion of drugs and medical devices has “raised questions and concerns over how to apply existing regulations to promotion in these newer media,” FDA officials said. In order to keep pace with new promotional tactics, the FDA may have to give the drug industry more information about how existing FDA rules for drug promotion should be applied to web-based marketing.

FDA Branch Polices Drug Marketing

The DDMAC is responsible for reviewing prescription drug advertising and promotional labeling to ensure that the information contained in these promotional materials is not false or misleading. Among the duties of the DDMAC are:

•Providing written comments to pharmaceutical sponsors on proposed promotional materials to ensure clear and unambiguous communication of the laws and regulations relating to prescription drug promotion

• Reviewing complaints about alleged promotional violations

• Initiating enforcement actions on promotional materials that are false or misleading

• Comparing the product labeling and promotional materials of various closely related products to ensure that the regulatory requirements are consistently and equitably applied

• Traveling to major medical meetings and pharmaceutical conventions to monitor promotional exhibits and activities

• Acting as a liaison between DDMAC and other divisions within the FDA on promotional issues

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