FDA Proposes Guidelines for Posting Medical-Product Information Online

A lot can be misconstrued in the silent world of the Internet. While online technology has changed the communications paradigm, it also has resulted in bad information, embarrassing typos, factual errors and malfeasance.

Fake Web sites, botched emails, rambling blogs and photo abuse appear in cyberspace every day. Most of it is innocuous. But the stakes are higher for the medical community as it adapts to and enters the digital realm.

What is social media“In today’s world, in addition to traditional sources of medical product information, patients and health care providers regularly get information about FDA-regulated medical products through social media and other Internet sources, and those technologies continue to evolve,” wrote Thomas Abrams, of the Food and Drug Administration’s Office of Prescription Drug Promotion, on the FDAVoice blog. “But regardless of the Internet source used to communicate about medical products, the public health is best served by clear, accurate, truthful and non-misleading information about them.”

The agency has acknowledged the convenience, importance and popularity of social media as a resource for the medical community and industry-at-large by developing a set of best practices for current and future sites. The best practices come in the form of two proposed guidances, the goals of which are to help companies state the purposes of their products with the utmost honesty.

Both guidances relate to medical devices and prescription drugs.

“These documents strive to ensure that the information provided by drug and device companies is accurate and will help patients to make well-informed decisions in consultation with their health care providers,” Abrams wrote.

The first guidance addresses posting information to Twitter and paid-search sites that have character limits. The task of presenting the benefits and risks of a product in 140 characters or less can be daunting – and dangerous.  Both sides of the story need to be told, and a link or a phone number should be provided to give consumers a way to get more information from the company or an additional source.

The second guidance recommends ways for companies to correct information relayed about their products online, whether in a blog or on a Facebook post, whether negative or positive.

“We developed these new guidances, in part, to respond to requests for best practices from companies and other stakeholders,” Abrams wrote. “We gave careful thought to our draft recommendations, and we understand technology will continue to evolve.”

Because of the inherent risks posed by medical devices (defects) and prescription drugs (addiction), and their respective benefits (improved lifespan and disease prevention), the agency prioritized the proposed guidances.

“As a regulatory agency, we are committed to ensuring that the information about these products that their manufacturers and distributors direct at patients and health care providers is accurate and balanced,” Abrams wrote.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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