sábado, 13 de octubre de 2012

About the Center for Drug Evaluation and Research > The Office of Prescription Drug Promotion (OPDP)

About the Center for Drug Evaluation and Research > The Office of Prescription Drug Promotion (OPDP)

The Office of Prescription Drug Promotion (OPDP)

(formerly Division of Drug Marketing, Advertising and Communications - DDMAC)

Office Location:
10903 New Hampshire Ave., Building 51, Room 3200
Silver Spring, MD 20993-0002

Phone and Fax Numbers:
Phone: 301-796-1200
Fax: 301-847-8444 or 301-847-8445
"To protect the public health by assuring prescription drug information 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."
OPDP has transitioned to a new tracking system. There are new requirements when submitting requests for advisory. For more information, please refer to the following:

Risk Communication Advisory Committee; Notice of Meeting
Information About What OPDP Reviewers Do
OPDP reviewers have responsibility for reviewing prescription drug advertising and promotional labeling to ensure that the information contained in these promotional materials is not false or misleading. They engage in a variety of tasks to perform this responsibility, including: 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; and acting as a liaison between OPDP and other divisions within the FDA on promotional issues. Interested in a position at OPDP?
Important Information About Submissions
OPDP reminds all companies who are engaging in DTC advertising of prescription drugs that the requirements of section 906 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) went into effect on March 25, 2008.  Section 906 of FDAAA mandates that published direct-to-consumer advertisements for prescription drugs include the following statement printed in conspicuous text:  "You are encouraged to report negative side effects of prescription drugs to the FDA.  Visit www.fda.gov/medwatch, or call 1-800-FDA-1088."
Proposed DTC TV Advertisements Voluntarily Submitted for OPDP Advisory Review
Please visit OPDP’s submission page for information on the components of a complete and reviewable DTC TV submission package, and for information on other submissions.  OPDP’s submissions web page is available below.
Truthful Prescription Drug Advertising and Promotion (Bad Ad Program)
The Prescriber's Role - Recognize and Report

FDA's educational outreach program is designed to educate healthcare providers about the role they can play in helping the agency make sure that prescription drug advertising and promotion is truthful and not misleading.
The "Bad Ad" Program is administered by the agency's Office of Prescription Drug Promotion in the Center for Drug Evaluation and Research. It will help healthcare providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency.
Truthful Prescription Drug Advertising and Promotion (Bad Ad Program)
Information about the status of the DTC user fee program enacted under the Food and Drug Administration Amendments Act of 2007 (FDAAA) is posted at the
Direct-to-Consumer (DTC) Television User Fee Program Documents


OPDP Resources

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