Healthy Skepticism Library item: 18913
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: Electronic Source
Silverman E
When Is A White Paper Really Just A Promotion?
Pharmalot 2010 Nov 15
http://www.pharmalot.com/2010/11/when-is-a-white-paper-really-just-a-promotion/
Full text:
Mention the phrase ‘white paper’ and an authoritative guide to a particular policy issue may spring to mind. Of course, white papers may also be nothing more than promotional thoughts dressed up as think pieces. And that’s what the FDA has decided the Ipsen Group did in creating and distributing a paper about Insulin-like Growth Factor Deficiency, an affliction in which growth is inhibited.
In a recently disclosed warning letter, the agency took Ipsen to task for omitting important risk info and broadenening the indication for its Increlex treatment. But the underlying issue was that the white paper wasn’t really a white paper and there were several tell-tale signs that offer some interesting insight into agency thinking on such situations.
To wit, the FDA noted there is an implied reference to Ipsen’s Increlex, which is the only approved IGF-1 treatment, suggesting the med is likely to be a familiar name to the targeted audience. The paper cites a study involving Increlex to support a statement that IGF-1 accelerated growth in children. The FDA also notes Ipsen’s Tercica unit is identified on the first page of the paper and charts were modified to include the same colors that appear on promo materials submitted by Tercica for agency review. In other words, if a white paper reads like a promo piece and looks like a promo piece, well…
“This is an important warning letter and tells us much about FDA’s views on disease awareness versus promotional materials,” Arnie Friede, a former FDA associate chief counsel and a former senior corporate counsel at Pfizer, writes us, while noting that Tercica initially submitted the material to FDA on a form that is used for promotional review.
“If this material was intended to be non-promotional, disease awareness information, then one needs to ask why the company elected to submit it to FDA via a 2253. That is intended to be used for promotional submissions. I do understand that many companies voluntarily submit non-promotional, disease awareness information to FDA and there is something to be said for that practice. At the same time, this certainly increases the odds that the (Division of Drug Marketing, Advertising, and Communications) will express an opinion on the materials.”
He adds that the factors mentioned by the FDA were cited in a 2004 Draft Guidance on disease awareness (read here) and also mentioned in a warning letter issued earlier this year to Novartis regarding unbranded web sites for Gleevec (see this). “It may well be that each individual factor in its own right might not have caused DDMAC to characertize the material as promotional,” Friede opines. “However, the combination of factors certainly did.”
