FDA Official States Need for Greater Data from Public Stakeholders and Industry to Inform the Guidance Process for use of Internet and Social Media in the Promotion of FDA-regulated Medical Products

IRVINE, Calif., Feb. 9 /PRNewswire-FirstCall/ -- In an exclusive interview with Fabio Gratton, Chief Innovation Officer at Ignite Health, Dr. Jean-Ah Kang, Special Assistant to Director Tom Abrams at the Food and Drug Administration's Division of Drug Marketing, Advertising and Communications (DDMAC), recently re-stated and emphasized that the FDA is requesting additional information from the public, including pharmaceutical companies and other health organizations, to help the Agency determine whether explicit Internet-specific guidance should be drafted, and if so, what considerations should be made.  The full transcript of the interview is available as a free download on www.fdasm.com.

The interview marks the first time the FDA has spoken publicly on this topic since the two-day public hearings held last November, during which the FDA heard 77 presentations from pharmaceutical companies, communication agencies, consultants, research firms, search engine companies, trade organizations, and non-profit groups on the topic "Promotion of FDA-regulated medical products (including prescription drugs for humans and animals, prescription biologics, and medical devices) using the Internet and social media tools."

Following the hearings, as the next step in what the FDA calls "Good Guidance Practices," the FDA requested that additional supporting data and comments be submitted to the Division of Dockets Management by February 28, 2010.  To date, the public docket has 14 comments.  (To view all current documents in the docket or submit your own, go to www.Regulations.gov.  Use docket #FDA-2009-N-0441).

"We really do want comments," states Dr. Kang.  "It's really important to us. This is the chance for the public to really be actively involved because we are going to review all the data and comments. We're going to take them all into consideration and that is going to be the basis for next steps so I really encourage public involvement.  This is a challenging issue but it's also an exciting time.  We as an Agency encourage people to actively be involved and participate in whatever way that they can."  

According to Dr. Kang, the DDMAC official leading the efforts around guidance and policy issues specific to the Internet and social media at the FDA, the information presented at the Part 15 Public Hearing was a critical first step of the overall guidance process, a step which enables the public to participate and share their perspectives on the topic in the Federal Register notice.  Dr. Kang emphasized the importance for organizations or groups to submit new data or continuing research whether it's gathered through focus groups, online surveys, or even gathered from observing how people interact with fictional drug promotion on search engines and health portals.

"The FDA is a data-driven agency so if you have data to support a particular opinion or a position on an issue, that's really important.  A lot of our decisions are based on having good, solid, robust data," said Dr. Kang.

Dr. Kang also expressed that, while the FDA is working to collect all of the information by the February 28 deadline, they will continue to accept comments after this date.  This news is particularly important to companies that are in the process of planning or currently conducting research but might not have it completed or analyzed in time.  In such cases, she recommends that companies provide the FDA with some kind of advanced notice that they are planning on submitting late.  Submitting an outline or abstract of the research could also prove useful.  

"I believe the FDA is truly committed to engaging the industry and moving this process forward. By issuing this request, they are creating better clarity on how the industry can supply them with the right data to support the development of guidance that will enable them to effectively, appropriately, and compliantly communicate using these tools," said Gratton, who was also one of the presenters at the public hearings last November.

In her interview with Mr. Gratton, Dr. Kang provided clarification and direction to the industry, including the Agency's perspective on technology and social media, thoughts on the public hearing itself, what to expect from the ongoing guidance process, more details about the extended period for data submission, and her recommendations for what companies should be doing in the meantime.

Other highlights from the interview include Dr. Kang's comments on:

• How the guidance process works
• Why starting data gathering today is not useless
• What the FDA can do to help
• How best to stay apprised of new developments
• When the FDA will make its next public appearance

"I think it's our responsibility as an industry to provide the FDA/DDMAC with as much supporting data as possible, so at the end of this journey we will have contributed to the development of guidelines that are specific enough to be actionable, broad enough to endure, and permissive enough to enable safe, effective, and responsible use of these new technologies," Gratton continued. "If we don't participate, this industry runs the risk of finding itself on the social media sidelines for a long time – and not because we don't belong in the space, not because we don't have something valuable to contribute to the conversation or because the patients don't want us there or because we wouldn't know how to act with integrity – but simply because we didn't provide the FDA with the information they needed to help create a guidance that strikes the right balance between all these things.  That, in my opinion, would be a real shame."

To read the full transcript of this interview, go to: www.fdasm.com.  To find more about the public hearing and information related to the guidance process from the FDA go to: http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm184250.htm.  Individuals can also follow @FDASM on twitter at http://www.twitter.com/fdasm.

About FDASM.COM

The site (www.fdasm.com) was created by Fabio Gratton, Chief Innovation Office at Ignite Health, as a free resource to the industry to provide complete coverage related to the FDA Part 15 Public Hearings, and all the developments thereafter.  The site contains s a real-time-twitter stream of all discussions surrounding this topic based on the Twitter hashtag #FDASM. Since the site's launch in late 2009, the site has been visited by more than 100 pharmaceutical and medical device companies, hundreds of marketing firms, thousands of individuals, and has been featured in Business Week and CNBC.  This site is not affiliated or endorsed by the FDA.

About Ignite Health

Ignite Health, an inVentiv Health company (Nasdaq: VTIV), is a new breed of advertising agency with a fresh approach to healthcare marketing and communications. By complementing highly focused print strategies with a wide range of tailored digital strategies – from online advertising and patient education to custom-engineered games and simulations – the company helps clients meet their objectives with unparalleled effectiveness and efficiency. For more information, visit www.ignitehealth.com

About inVentiv Health

inVentiv Health, Inc. (Nasdaq: VTIV) is an insights-driven global healthcare leader that provides dynamic solutions to deliver customer and patient success. inVentiv delivers its customized clinical, sales, marketing and communications solutions through its four core business segments: inVentiv Clinical, inVentiv Communications, inVentiv Commercial, and inVentiv Patient Outcomes. inVentiv Health's client roster is comprised of more than 350 leading pharmaceutical, biotech, life sciences and healthcare payer companies, including all top 20 global pharmaceutical manufacturers. For more information, visit www.inventivhealth.com.

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