Acronym of the week would be more accurate, but GDUFA will be used as a word so it might as well be defined as one. With the passage of the Food and Drug Administration Safety and Innovation Act on July 9, 2012, GDUFA (‘Generic Drug User Fee Amendments...
by Tim Weinheimer, Senior Vice President, Group Account Director
process of prescribing, dispensing and using
medications leaves little room for medical errors when the health of the consumer is at stake.
The same holds true in making sure there is no room for error in “dispensing” prescription drug and medical device information on your web sites. The new FDA guidelines present the opportunity to ensure your customers can and will find readily accessible and accurate off-label information across your company and branded web properties. With the new FDA guidance for responding to unsolicited requests for off-label information, it may be time for a cross-domain audit of your web properties – an audit to simply ensure such off-label information is current and meeting FDA requirements.
Per the FDA recommendations, a firm’s contact and disclosure information, a public response should include a mechanism for providing readily accessible current FDA-required labelling, if any, for the product (e.g., FDA-approved package insert and, if the response is for a consumer, FDA-approved patient labelling or, for new animal drugs, FDA-approved client information sheet.
A simple cross-domain audit will verify these requirements:
- My firm’s public response does not provide or link to any promotional product information.
- A direct link URL to the current FDA-required labeling is available where visitors are directed to obtain FDA-required labeling.
- This direct link is made available in all the public places where customers might be searching for or stumble upon through search product information on the firm’s web controlled properties.
Prescription drug and medical device information is widely available across the social web. And medical information is often complicated and difficult for consumers to understand already. This simple audit will quickly examine that your web domain is order when it comes to web search-oriented public responses/requests. How do you plan to handle unsolicited requests from across the social web?
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