Friday, September 22, 2006

PhRMA's OOA Issues First Report

Back in May, 2006, I wrote to PhRMA's Office of Accountability (OOA) complaining that Sepracor was "sneaking" in Lunesta "reminder ads" despite being a signatory to PhRMA's Guiding Principles for DTC Advertising (see "Wake Up PhRMA! or Tilting at Windmills"). Read my letter here.

It took more than 2 months for the OOA to respond and when it did the response was both a joke and an insult, which I prompted protested. You'll recall at that time someone named Emily Johnson (no title) responded in one or two sentences on handwritten letterhead. Emily, I guessed, was a hapless, unsupervised intern tasked beyond her capabilities (see "Adventures of PhRMA Intern!").

OOA Grows Up!
Since then the OOA has evolved and gotten some grown-up leadership. PhRMA's Chief Medical Officer, Dr. Paul Antony, was named as Director of the Office and will "supervise the Office's work." Emily should be happy about that. Maybe Antony will order some stationery as well.

The OOA also has improved its Web page making it easier to report violations ("submit comments") of the Guiding Principles by signatory drug companies.

You can now also identify members of the Review Panel whose purpose "is to provide transparent, unbiased analysis of the industry-wide progress made in improving direct to consumer advertising consistent with the new guidelines." The panel's main task is to "review reports from the Office of Accountability and evaluate overall DTC trends in the industry." The panel's observations and recommendations will be published in early 2007, and a copy of the panel'’s report will be provided to the FDA.

Up until now the panel had nothing to review -- no report from PhRMA had been issued. I just discovered, however, that a report was recently issued! If you go to the OOA' Web page -- as I am sure you do at least every Monday like clockwork -- you will see "New! Read the Office of Accountability report just issued". [You won't see, however, any press release from PhRMA about this.]

["New" is that tiny little starburst icon that was popular among amateur webmasters in the 90s.]

My Comment Has Been Counted! I Think.
The report analyzes comments received between January 6, 2006 and June 30, 2006. Here's the methodology:
PhRMA's Office of Accountability conducted a survey of all signatory companies in July 2006 asking them for the number and nature of comments they received (both through the Office as well as independently) between January 6, 2006, when the Principles took effect, and June 30, 2006. Unless otherwise indicated, all information provided in this report is based solely on signatory companies' survey responses.

The letter I got from Emily in July, 2006 was dated June 29, 2006. Here's Emily's letter
in toto:

June 29, 2006

Dear Mr. Mack:

Thank you for your comment regarding PhRMA's Guiding Principles on Direct to Consumer Advertisements About Prescription Medicines. We appreciate your feedback on compliance with the Guiding Principles.

Your comment has been forwarded to Sepracor for consideration.

Sincerely,
Emily M. Johnson
Office of Accountability
So, my comment made it under the wire! I assume it was counted, therefore, in the OOA's first report!
[My only concern is that Sepracor may NOT have responded to the OOA's survey. After all, it did not respond to my repeated direct requests for a response, so why would it respond to OOA? There's no way to know based on information in the OOA report, which does not list pharma companies that responded to the survey.]
The report characterized each or the 284 comments according to which Guiding Principle it was related to. It also noted whether the comment was about a TV or print ad and classified commenters as Patients/Consumers, Healthcare Providers, Consumer Advocacy Groups, or Other.

Guess which group submitted the most comments. Wrong! 88% of the comments came from Patients/Consumers. [You thought it was Advocacy Groups, right? C'mon, admit it.]

I'm not sure what group PhRMA put me in. Since I said I was the publisher of Pharma Marketing News, I would have guessed I'd be in the "Other" group. But no! Only 3 comments were submitted by this group and all of those were about print ads. My comment was about TV ads. Maybe PhRMA put me in the Consumer Advocacy Group, which submitted only 1 comment -- about a TV ad. Voila! There I am! Brilliant!



One Person can be as Effective as FDA
There was only one comment reported by OOA that concerned Principle 10, which calls for television advertisements to "clearly state the health conditions for which the medicine is approved and the major risks associated with the medicine being advertised." That has to be my comment!

The OOA report goes on to state:

"The commenter [that's me!] stated that the advertisement at issue did not meet this standard. The signatory company [that would be Sepracor] reported 'conducting an internal review, withdrawing the advertisement at issue, and modifying other messages to make it clear that they are sponsorships that do not fall within the Principles' definition of a DTC television advertisement.' "

My interpretation of Sepracor's response is (1) we stopped running the reminder ad for Lunesta on TV, and (2) we are still running reminder ads, but not on TV. Call it obeying the letter, not the spirit of the Guiding Principles.

I note that I have been at least as effective as the FDA in getting a drug company to close the barn door (pull the ad) after the cows have left (after the ads have run).

Of course, I am assuming that this response was from Sepracor based on the logic of Occam's razor or is it Sherlock Holmes' maxim: "Eliminate all other factors, and the one which remains must be the truth." Whatever!

Sepracor, however, remains silent and still has not returned my calls or responded to my letters to the CEO and corporate communications director.

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