Change FDA promo guidance: group

Share this article:

Two industry groups, one representing health communicators and the other medical device makers, have sharply criticized a draft FDA guidance on how to present risk information in promotional materials.

In comments submitted to the agency, the Coalition for Healthcare Communication (CHC) said it is concerned that the FDA's draft guidance on risk information in drug and medical device promotion will curtail truthful advertising by providing regulators with faulty reasoning to find a truthful advertising piece false or misleading. It said that the guidance may also discourage advertisers from presenting otherwise truthful information.

The coalition's comments said that the principles described in the guidance must be more fully described, limits to their application must be more fully established and that all must be accomplished within the limits of the Federal Food, Drug and Cosmetic Act and the First Amendment.

Saying that the draft assumes new authority that reaches far beyond both the law and existing regulations, the CHC criticized it for expecting “that all advertising and promotional material contain enough information for an informed decision as to whether or not a drug should be chosen for use. This can only occur after a healthcare professional evaluates a specific product in relationship to a particular patient's needs.”
Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Features

Email Newsletters

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Features

Read the complete October 2014 Digital Edition

Read the complete October 2014 Digital Edition

Click the above link to access the complete Digital Edition of the October 2014 issue of MM&M, with all text, charts and pictures.

Predicting your pink slip

Predicting your pink slip

Any time a firm needs to save money, high-salaried executives are targets

Private View: New ways to engage with customers

Private View: New ways to engage with customers

These healthcare social media campaigns successfully use emotion, altruism and the human desire to "brand" oneself to get customers engaged.