Guidance on the Promotion of Medical Products

Nancy Muller Health Pro
  • As increasing paid advertising by the pharmaceutical and medical device industries seeks to influence the American public, the FDA has finally undertaken an educational campaign to help inform consumers on FDA regulation of medical product promotion. In September of 2008, the government agency launched a "one-stop shop" to provide consumer information and guidance for viewers of television, radio, and print advertisements for branded prescription drugs. The consumer web site "Be Smart about Prescription Drug Advertising: A Guide for Consumers" is designed to educate consumers about how to view such advertising.

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    I find it refreshing that the FDA recognizes the need to provide relevant information that is also engaging, accurate, and helpful to discerning symptoms and intervention for managing and treating conditions.

     

    The FDA site creatively uses interactive examples of advertisements in a fictionalized but realistic setting to illustrate the different types of ads and how viewers should interpret the category of messaging: 1) a product claim; 2) a reminder ad; and 3) help-seeking ad. There are also questions that viewers should ask themselves when viewing such an ad to determine if the symptoms as presented are typical of what they are experiencing. This helps to frame the subsequent discussion that the consumer might have with a doctor, both about the condition and about medications for help in addressing symptoms.

     

    The entire site is professional, comprehensive, and instructional. It's friendly and accessible, as well. Every health-seeking adult in America should visit the site, if you are regularly taking one or several prescription drugs - or assisting in the care and guidance of others such as parents who are on medication.

     

    Some of the most heavily advertised conditions today are overactive bladder (OAB). Most of the OAB drug advertisements seek to build awareness of the condition, describe symptoms to help people draw a connection to a legitimate medical condition that warrants treatment, and encourage a visit to the doctor.

     

    In general, the OAB drug ads do appear to fairly represent symptoms and communicate effectively how people's lives are affected. Consumers should watch out for language that exaggerates, or overdramatizes, the seriousness of the condition or the degree of severity of symptoms most likely encountered.

     

    Visit NAFC for a full listing of FDA approved medications for OAB, including urge incontinence:

     

    http://www.nafc.org/bladder-bowel-health/types-of-incontinence/urge-incontinence/#Medications

     

    NAFC adheres to a strict policy of not endorsing one product over another. While sections of our web site may be underwritten by a grant from a company, as are our printed, educational brochures and booklets, we do not allow pop up messages or commercial product advertising. Nor is content written or edited in any way by corporate sponsors. All content is provided and reviewed by clinicians who donate their time and expertise. All authors sign legal disclosure statements that we retain on file revealing any financial interests they may have in a company or product. Any pages of the newsletter that contain a paid advertisement, are labeled as such and restricted in number. As a 501 (c) 3 corporation, we are broadly funded by consumers, healthcare professionals, and industry.

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    As time passes, OAB drug marketers are likely to shift to more competitive ads in which product claims are made, such as we see today with many cardiovascular medications, and even to reminder ads, such as those for colds and flu symptoms, in an effort to boost adherence to prescriptions and reinforce brand loyalty. If making product claims, such categories of ads should present a fair balance of information between risks and benefits. Reminder ads must mention the drug's brand name and generic name so that consumers recognize they have a choice if both exist.

     

    The FDA has a companion site, "Advertising Prescription Drugs and Medical Devices" web site that is useful to those working in industry or who are otherwise policy users such pharmacy chain administrators who can obtain information about relevant laws, regulations, and guidelines governing prescription drugs.

     

    For too long, the Administration has advocated "public-private partnerships" without demonstrated evidence of their applicability and benefit to the general public. Here is evidence they exist and with value.

     

    I urge all of you to check it out and give your feedback to the FDA on ways that the sites can be continuously improved and enriched.

     

Published On: January 05, 2009