OP-ED

The FDA Steps In: Regulating Prescription Drug Promotion on the Internet

KATE GREENWOODKate-greenwood-7-16-08-compressed-200x300

The FDA has been widely criticized for not providing guidance for drug companies eager to promote their products on the internet.  Earlier this year, the FDA expressed the view that the message was what was important, not the medium, meaning that companies should simply apply the rules governing prescription drug advertising in print media to the internet.  On April 2, 2009 the agency issued Notice of Violation letters to 14 companies who sponsored links on internet search engines advertising their products; the links gave the name of the drug and, in some cases, its indicated use, without including the required “fair balance,” i.e., safety information such as contraindications and potential side effects.  In reliance on the so-called “one-click rule” — which had never actually been adopted by the FDA — the companies had put the required safety information one click away on a separate page.

In recent months, the FDA has indicated that it is open to providing internet-specific marketing guidance.  Yesterday and today (November 13th) the agency is holding a hearing on “Promotion of FDA–Regulated Medical Products Using the Internet and Social Media Tools.”  Representatives from advertising agencies, consumer groups, health-related websites, pharmaceutical companies, and search engines are scheduled to testify.

In written testimony released before the hearing, PhRMA, the pharmaceutical industry’s trade group, proposed that the FDA approve a standard universal warning: PhRMA suggests “All drugs have risks.  Click here for more information from the manufacturer.” — for use “in places throughout the Web where there is not enough room for complete disclosure of all warnings, indications, and contraindications (e.g., search results and microblog posts.)”  Such a warning would, PhRMA argues, allow companies to take advantage of sponsored links, make full use of Twitter, etcetera, while also providing easy access to safety information.  PhRMA even suggests that the warning incorporate the FDA’s logo, arguing that this could mitigate against “the dangers posed by illegal Internet drug sellers.”

It will be interesting to see whether and how the proposals of the other groups represented at the hearing differ from PhRMA’s, and, of course, whether the FDA in the end decides that its “fair balance” requirements should be modified for the web.  Among the other interesting issues FDA may address is companies’ responsibility for web content they do not control.  Google’s introduction of Sidewiki, which allows anyone visiting a pharmaceutical company’s website to leave a comment, has brought this issue to the fore, raising, for example, the prospect of doctors discussing a product’s off-label uses on the manufacturer’s site.

Anyone who wishes to comment on these or other internet-specific promotion issues may do so through February 28, 2010.

Post first published at Health Reform Watch , a publication of Seton Hall Law School. Since joining the Seton Hall Center for Health & Pharmaceutical Law & Policy in 2008, Kate Greenwood has co-authored two white papers, prepared and disseminated a position paper in support of draft New Jersey legislation which, if passed, would legalize marijuana for medical use, and jointly planned and participated in the Center’s forum on conflicts of interest in clinical research recruitment and enrollment.  Kate’s scholarly interests include prescription drug regulation and maternal and child health law and policy; she blogs on these topics at Health Reform Watch.  Her article on legal and regulatory approaches to encouraging the evaluation of existing drugs to determine their safety and efficacy when used during pregnancy was selected for presentation at the 2009 St. Louis University Health Law Scholars Workshop. Kate came to Seton Hall from Covington & Burling LLP, where she represented pharmaceutical companies in a variety of corporate, litigation, and white collar matters.  Before joining Covington, Kate was an Equal Justice Works Fellow and Staff Attorney at the Association of the Bar of the City of New York from 1999-2001, a law clerk to the Honorable Mary A. McLaughlin of the Eastern District of Pennsylvania from 2001-2002, and a law clerk to the Honorable Maryanne Trump Barry of the Third Circuit Court of Appeals from 2002-2003.

Kate graduated magna cum laude from Georgetown University Law Center, where she served as an Articles Editor of The Georgetown Law Journal.  She received her undergraduate degree in Economics from Swarthmore College.

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  2. First of all, I am President of a healthcare interactive agency engaged in both online DTC and DTP marketing – just to get that out of the way…
    I attended the FDA Internet and Social Media hearings and I have a few thoughts that have been bothering me ever since.
    The hearings suffered from a tendency on the part of speakers to repeat the same thing over and over again, I suppose in the hopes that the FDA would just believe it if they heard it often enough. A few of these repeated assumptions included:
    – Pharmaceutical companies are the best providers of online healthcare information simply because their marketing materials are regulated by FDA.
    – DTC marketing, and pharmaceutical companies potential use of social media, advances health literacy and public health – consequently, by limiting industries’ participation the FDA is limiting the public health benefit available through the Internet.
    – DTC marketing is educational in nature and patients want more of it and want pharma to join the conversation in online health communities.
    Some of the data-driven presentations were interesting particularly those that showed results of studies on how patients really interact with risk and side effect information in online ads and on product websites. However, the studies were limited in size and need to be enlarged before conclusions can be drawn.
    It was unfortunate that the hearing was not attended by more of the online patient community and I would suggest that FDA would benefit from holding a second hearing for this group or that they broadly communicate the request for comment and the open docket through their own social media efforts.
    Pew data was quoted continually to prove that more and more people, patients, and physicians are looking for healthcare information online but the data was used primarily to support the idea that pharma marketing should be more freely delivered to healthcare information seekers.
    So why did any of this bother someone who is paid to develop DTC and DTP marketing campaigns?
    – I passionately believe in patient empowerment
    – I fully believe that education and easy access to real medical information is critical in taking control of your health
    – I understand and use the Internet as a powerful information gathering and distribution tool every day
    – I do not accept that DTC advertising is educational in nature. (Companies do develop educational programs but these are separate from advertising and in my experience have been second in line when it comes to budget allocation.)
    – I question the assumption that companies are the best online sources of medical information for patients
    I am concerned that not enough voices were heard during the hearings and that it became and continues to be an agency and industry dominated conversation. Just read the posts on #fdasm before, during and after the hearings.
    I encourage e-patients, patient advocates, online patient communities to submit comments to the docket that specifically address the questions posed by the FDA available here:
    http://edocket.access.gpo.gov/2009/E9-22618.htm
    Docket is open until February 28 2010.

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