Health and Medical News and Resources

General interest items edited by Janice Flahiff

[FDA program aimed at health care providers] Truthful Prescription Drug Advertising and Promotion

This page is geared towards health care providers, but it may be of interest to others.

From the US FDA (Food and Drug Administration) Web page 

FDA’s Bad Ad program is an outreach program 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 (OPDP) in the Center for Drug Evaluation and Research. The program’s goal is to help raise awareness among healthcare providers about misleading prescription drug promotion and provide them with an easy way to report this activity to the agencye-mail BadAd@fda.gov or call 855-RX-BADAD.

Continuing Medical Education Video itself is free for anyone to view (http://www.sigmatech.com/BadAd/courses/index.htm)It covers what is legal/illegal for pharmaceutical companies and their representatives when advertising their products at different venues

Prescription drug advertising must:

  • Be accurate
  • Balance the risk and benefit information
  • Be consistent with the prescribing information approved by FDA
  • Only include information that is supported by strong evidence

What types of promotion does OPDP regulate?

  • TV and radio advertisements
  • All written or printed prescription drug promotional materials
  • Speaker program presentations
  • Sales representative presentations

OPDP does not regulate promotion of:

  • Over-the-Counter Drugs
  • Dietary Supplements
  • Medical Devices

Common Violations:

    • Omitting or downplaying of risk
    • Overstating the effectiveness
    • Promoting Uses Not Addressed in Approved Labeling
  • Misleading drug comparisons

 Examples of Violations

Example of Omission of Risk

You attend a speaker program which features a slide show that presents efficacy information about Drug X, but no risk information.

This presentation would be misleading because it fails to include a fair balance of benefit and risk information for Drug X.

Example of Uses Not Addressed in Approved Labeling
You are in a commercial exhibit hall and a company representative tells you that a drug is effective for a use that is not in the FDA-approved product labeling.

This presentation would be illegal because it promotes an unapproved use.

Example of Overstating the Effectiveness

“Doctor Smith, Drug X delivers rapid results in as little as 3 days.”

This presentation is misleading because the majority of patients studied in the clinical trials for Drug X showed results at 12 weeks, with only very few showing results in 3 days.

Frequently Asked Questions

1. Can I report anonymously?

Yes, anonymous complaints often alert FDA to potential problems.  However, complaints accompanied by names and contact information are helpful in cases for which FDA needs to follow-up for more information.

2. Will OPDP be able to stop the misleading promotion?

In many cases, yes, especially if the appropriate evidence is provided.  Evidence can include the actual promotional materials or documentation of oral statements made by company representatives.

3. What will happen to my complaint once I have contacted OPDP?

The information you provide will be sent to the Regulatory Review Officer in OPDP responsible for this class of drugs.  The reviewer will evaluate it and determine if it may serve as the basis for a potential enforcement action or as valuable information for our ongoing surveillance activities.

4. How do I learn more?

To learn more about OPDP in-service training for large medical group/hospitals call 301-796-1200.

November 5, 2013 Posted by | Educational Resources (High School/Early College(, Health Education (General Public), Librarian Resources, Professional Health Care Resources | , , , , , | Leave a comment

   

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