November 2009 Archives

Coalition Statement - DTC Advertising

Recent news coverage regarding a Harvard Medical School study showing correlation between Plavix price increases for Medicaid programs in 27 states and direct-to-consumer advertising costs is unfounded. As study authors concluded, DTC advertising was not associated with an increase in Plavix use above preexisting trends.  Additionally, Medicaid pharmacy expenditures increased substantially only after the initiation of DTC advertising because of an increase in the cost per unit.  These findings prove nothing about DTC advertising value for patients, or even the relationship between DTC advertising and product pricing.

DTC plays a critical role in informing patients about their treatment choices, and as the starting point in a dialogue between physician and patient in defining a treatment path. The Coalition supports responsible, effective communication on treatment benefits and risks that improve physician-patient dialogue and foster better care. Limiting FDA-vetted healthcare information impedes access to fair-balance information and stunts two-way dialogue between a patient and their doctor critical to improving medical treatment and quality-of-life.

Highlights, commentary and analysis of the November 12th and 13th testimony at the FDA's Public Hearing on the Internet and Social Media:

Coalition Message on Social Media Hearings
By John Kamp, Executive Director
Analysis of the issues

Paper on FDA Public Hearing on the Internet and Social Media
By Peter Pitts, Center for Medicine in the Public Interest
Documentation, timeline, analysis

Highlights of FDA Public Hearing on the Internet and Social Media
By Mark Marmur, Markovsky + Company
Summary of each item of testimony for both days

Click to view.



Comments are invited.

In his Drug Wonks blog, Peter Pitts wrote the following overview of Day 2 of the FDA hearing on social media. He highlighted the diverse views and concerns of witnesses on the subject of "adverse event" reporting and publicity.

    "Adverse event generation is the real bête noire of social media.

    "Should companies actively avoid participation - even to the degree of monitoring - lest they uncover an adverse experience?  Shouldn't companies embrace social media so that adverse experiences can be found with greater alacrity?  Shouldn't companies be rewarded for such behavior? If regulated industry wants the FDA to be both regulator and colleague, then it's not a leap of faith to imagine that the FDA would like industry to be proactive in its search for new ways to surface adverse events.

    I know of one large pharmaceutical company whose policy is not to monitor social media sites because they don't want to unearth adverse events.  Is this responsible?  Is it even supportable?  If this company received a call from a reporter and was asked if they purposely avoid social media so as not to find adverse experiences, would the truth set them free? Legally they may be in compliance, but it wouldn't look good on Page One or sound very good in front of a congressional subcommittee.  "In compliance" and "in the best interest of the public health" must not be mutually exclusive propositions."

Read the rest of Friday's summary on DrugWonks.com.   We want to hear your comments here.

In his Drug Wonks blog Peter Pitts, founder of the Center for Medicine in the Public Interest (CMPI) comments on all the testimony of the first day of the FDA's Part 15 Hearing on Social Media.

About John Kamp's testimony on behalf of the Coalition and the 4As, he wrote:

"Next up was the always effervescent John Kamp (representing the 4As and the Coalition for Healthcare Communication.) He picked up the tempo quite considerably by pointing out that the Internet is the "go-to" medium and that the FDA should step forward and set the global "gold standard" for social media regulations.  He also wisely pointed out that the FDA should develop its guidelines in collaboration with the FTC."

He also commented in a positive way on presentations by representatives of EURO RSG, McCann, and Google.

To view the entire Drug Wonk blog post, visit www.drugwonks.com.

We will post more information, links and summaries on Monday. Meanwhile, we welcome your comments.

At the November 12th FDA Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools, John Kamp, the Coalition's Executive Director, will present testimony on behalf of the Coalition and the American Association of Advertising Agencies. The testimony offers FDA a regulatory pathway to advance the public health by enabling robust marketing by regulated companies and at the same time coordinating effective enforcement against health fraud on the Internet. The Coalition/AAAA presentation will be delivered early on the first day of the hearing and lay the groundwork for testimony by other industry leaders.

View the slide presentation: CHC_FDA_SM_Forum_Nov09.pdf

We invite your comments!