by Carlene Olsen ( http://bit.ly/8WCD)
Article reprinted from "The Pink Sheet" DAILY April 7, 2009
Company-sponsored search results that appear on Internet search engines should not contain therapeutic claims if they also contain drug names, FDA suggests in a cluster of letters to 14 firms citing 48 products.
Sponsored search results - the links that appear on the top of a search return and include a promotional message - have become increasingly common as firms try to communicate with patients looking for health information online.
But the technology that allows patients to target their searches and sponsors to tailor their messages creates a host of problems when it comes to defining what the standards for advertising in the new medium should be. FDA has so far declined to issue Internet-specific guidance, saying it will use the print and TV standards as appropriate. Similarly, the Pharmaceutical Research and Manufacturers of America did not mention the Internet in the recent update of its principles for direct-to-consumer advertising.
In this case, the sponsored links are probably best interpreted as very short text advertisements, with FDA saying that if they contain the name of the drug and a therapeutic claim, they must also include risk information.
Which Standards Apply?
Typical among the cited links is a blurb for Sanofi-Aventis's Plavix "PLAVIX Medication Lowers Risks of Future Heart Attack or Stroke from PAD See how prescription PLAVIX medication may help patients with recent heart attack, recent stroke, or established P.A.D. at PADfacts.com." FDA says that in addition to lacking risk information, the link should have mentioned the product's generic name (clopidogrel).
Most of the firms that FDA cited in the round up, including Sanofi, say they were following what they thought was the standard for risk disclosure - providing it on the click through, akin to turning the page in a magazine. The agency, though, seems to interpret the sponsored links more like a bombastic sales aid with labeling attached: making the full information eventually available is not enough to overcome the misimpression created initially.
The citations will likely result in substantial rewriting of the search-result messages. One solution for firms would be to insert a "fanciful" name in place of a product name in a search engine link that leads to a company-sponsored product Web site, offered Ropes & Gray partner Alan Bennett.
"Anytime a drug name appears in conjunction with a claim, FDA appears to be taking a position that firms need to include all the product risk information ... the easy fix is to eliminate the drug name," Bennett said.
The combination of increasing Internet use and lack of clear regulatory standards was destined to produce violations, and while FDA has cited many Internet advertisements over the years, the sheer volume of the most recent batch of letter seems intended to convey the urgency of the agency's concerns about sponsored links.
"While conducting our routine monitoring and surveillance activities, we noticed regulatory violations occurring in sponsored link promotion across multiple drug companies and therapeutic areas; in response, we developed and issued multiple letters on multiple drugs simultaneously to prompt the correction of the violations we were seeing in these links and to maintain a level playing field for regulated industry," FDA said in a statement.
The agency released another thematic grouping of letters last fall citing attention deficit hyperactivity disorder products.
[Editor's note: Windhover is sponsoring a webinar on "How to Navigate Changing Trends in DTC Advertising." The May 20 event features Oregon Assistant Attorney General David Hart and McDermott, Will & Emery Counsel Arnold Friede. To register, visit http://www.windhover.com/ezine/html/ac0509-LP.htm, call 800-332-2181, or email firstname.lastname@example.org.]
Risk Management Creates Fewer Promotional Restrictions?
Among products cited in the spate of letters was Biogen Idec's multiple sclerosis and Crohn's disease drug Tysabri (natalizumab), which was pulled from the market because of a rare brain infection risk and returned with a tightly-restricted risk management program.
FDA's letter noted some of the sponsored links included the tag line "Satisfied with your MS Medication or Looking for Something Different?"
"Their casual approach to Tysabri treatment is extraordinary in light of the potentially lethal risks of the drug and the stringent controls over its distribution," the letter states.
Biogen appears to see the meaning of its risk management program differently. Although it is working with FDA to resolve the its concerns regarding the links, the firm pointed out that all patients receive the full risk information for Tysabri in mandatory talks with physicians, regardless of Internet searches.
"Unlike the other products flagged, Tysabri has a disciplined risk management program in place and no patient in the U.S. can gain access to the drug without formal enrollment in the REMS TOUCH program, so the risks are all clearly explained by the physician before prescribing," the firm said.
The C-list: FDA's citations
The companies cited in FDA's sweep involve nearly all the prominent drug firms. Pfizer, GlaxoSmithKline and Genentech received the largest number of FDA citations - six each - for volatile search links.
Pfizer's include: Aromasin (exemestane); Caduey (amlodipine besylate/atorvastatin calcium); Chantix (varenicline); Detrol LA (tolterodine); Lyrica (pregabalin); and Celebrex (celecoxib).
GlaxoSmithKline's include: Avandia (rosiglitazone) ; Avandamet (rosiglitazone/metformin) ; Avandaryl (rosiglitazone/glimepiride) Tablets; Avodart (dutasteride); Coreg CR (carvedilol); and Tykerb (lapatinib).
Genentech's include: Avastin (bevacizumab); Lucentis (ranibizumab injection); Rituxan (rituximab); Xolair (omalizumab); Herceptin (trastuzumab); and Pulmozyme (dornase).
Novartis received five citations including: Femara (letrozole); Diovan (valsartan) tablets; Exforge (amlodipine/valsartan); Exjade (deferasirox); and Gleevec (imatinib).
Forest Laboratories received four citations for Bystolic (nebivolol); Campral (acamprosate); Lexapro (escitalopram); and Namenda (memantine).
Merck also received four citations for: Januvia (sitagliptin); Propecia (finasteride); Singulair (montelukast); and Emend (aprepitant).
Firms with three citations include: Bayer for Levitra (vardenafil); Yaz (drospirenone/ ethinyl estradiol) and Mirena (levonorgestrel-releasing intrauterine system); Hoffma-LaRoche for Boniva (ibandronate); Pegasys (peginterferon alfa-2a); and Xeloda (capecitabine); and Boehringer Ingelheim for Spiriva HandiHaler (tiotropium); Flomax (tamsulosin hydrochloride); and Mirapex (pramipexole). As well as Lilly for Cymbalta (duloxetine); Evista (raloxifene); and Gemzar (gemcitabine).
Firms with two or fewer citations include: Cephalon for Fentora (fentanyl) and Treanda (bendamustine); Biogen Idec for Tysabri (natalizumab); Sanofi-Aventis for Plavix (clopidogrel); Johnson & Johnson for Prezista (darunavir).
Tuesday, April 07, 2009
by Carlene Olsen ( http://bit.ly/8WCD)