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Regulatory Alert Comorbidities & Linking Strategies - Digitas Health - September 2011

Regulatory Alert Comorbidities & Linking Strategies - Digitas Health - September 2011

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Published by Digitas Health
The FDA has taken enforcement action against promotional activities by Pfizer that further clarifies FDA’s view on website linking strategies. This action also has implications for the cross-promotion of other products treating comorbidities and franchise marketing efforts. Companies should scour existing promotional activities to ensure there are no mentions of products and indications without relevant risk information, and avoid mention of specific products as part of their linking strategies.
In addition, this violation was reported via the Bad Ad Program. FDA’s initiative to encourage health care professionals to report allegedly violative materials is clearly increasing those reports and industry needs to take heed.
The FDA has taken enforcement action against promotional activities by Pfizer that further clarifies FDA’s view on website linking strategies. This action also has implications for the cross-promotion of other products treating comorbidities and franchise marketing efforts. Companies should scour existing promotional activities to ensure there are no mentions of products and indications without relevant risk information, and avoid mention of specific products as part of their linking strategies.
In addition, this violation was reported via the Bad Ad Program. FDA’s initiative to encourage health care professionals to report allegedly violative materials is clearly increasing those reports and industry needs to take heed.

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Published by: Digitas Health on Sep 20, 2011
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03/04/2014

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Regulatory Alert
FDA Enforcement Action on Comorbidity & Linking Strategies
September 13, 2011
Analyst: Dale Cooke
EXECUTIVE SUMMARY
The FDA has taken enforcement action against promotional activities by Pfizer that further clarifies FDA’sview on website linking strategies. This action also has implications for the cross-promotion of other productstreating comorbidities and franchise marketing efforts. Companies should scour existing promotionalactivities to ensure there are no mentions of products and indications without relevant risk information, andavoid mention of specific products as part of their linking strategies.In addition, this violation was reported via the Bad Ad Program. FDA’s initiative to encourage health careprofessionals to report allegedly violative materials is clearly increasing those reports and industry needs totake heed.
BACKGROUND
On August 31, 2011, the Food and Drug Administration’s Division of Drug Marketing Advertising andCommunications (DDMAC) issued an untitled letter to Pfizer for its marketing of CADUET
®
(amlodipinebesylate/atorvastatin calcium) Tablets, CHANTIX
®
(varenicline) Tablets, and NORVASC
®
(amlodipine besylate)Tablets. Specifically, Pfizer had placed on the Lipitor.com website a link to the product sites, along with amention of the product names, and an abbreviated description of the product indications. On the webpage,there was risk information provided for the use of LIPITOR
®
(atorvastatin calcium) Tablets, but there was norisk information provided for Caduet, Chantix, or Norvasc.Another item worth noting about this enforcement activity is that FDA again attributed the action to a“complaint to the DDMAC Bad Ad Program.”
1
The Bad Ad Program, which was launched in May 2010,encourages healthcare professionals to report allegedly violative promotional materials to the FDA. FDA hastaken steps to educate healthcare professionals about advertising regulations for prescription drugs and haspromoted the program via webinars, press releases, and promotional videos.
2
So far in 2011, five of DDMAC’s 21 enforcement actions have been attributed to the Bad Ad Program. Clearly,this is now a major source for enforcement actions and all members of industry should assume that healthcare professionals are more aware of the advertising regulations, and because FDA has made it easier toreport allegedly violative materials, health care professionals are more likely to report them.
3
 It’s also worth noting that the use of links has been an ongoing area of interest for the FDA, dating back atleast to the 1996 hearings on the FDA and the Internet.
4
 This topic was again on the docket for the November2009 Part 15 hearings on the use of the Internet and social media tools to promote medical products.
5
 One of the detailed questions the FDA was seeking information about was “Should parameters be established forlinks to and from Web sites?”
6
 
RELEVANT FACTS
Lipitor is indicated as an adjunct treatment for high cholesterol for those at increased risk of coronary heartdisease. According to the promotional materials posted by the FDA, the webpage on Lipitor.com included alisting of other places online where people could learn more about heart health. At the top of the page,Pfizer posted information about other medicines that “may help manage other risk factors for heartdisease.”
7
Following that description were a series of links to the websites for Caduet, Chantix, and Norvasc,with a brief description of the indications for those medicines as shown
8
:CADUET
®
(amlodipine besylate/atorvastatin calcium)Learn about a treatment for high blood pressure and high cholesterol in a single pill.CHANTIX
®
(varenicline)Learn about a prescription drug to help people quit smokingNORVASC
®
(amlodipine besylate)Learn about a treatment for high blood pressure and the chest pain of anginaBelow this series of links, there was a paragraph about community programs and a list of links to third-partysites such as the American Heart Association, Centers for Disease Control and Prevention, and Mayo Clinicwith additional information about heart disease.At the bottom of the page, a larger description of the indication statement for Lipitor was provided followedby risk information including the contraindications, adverse events, and warnings and precautions.Nowhere on the page was any risk information about the use of Caduet, Chantix, or Norvasc provided.According to FDA’s letter,
9
clicking on the links took site visitors to a further Lipitor.com webpage with a“Click to Continue” link. Clicking on that further link took site visitors to the websites for the respectiveproducts, where the full PI was provided.
IMPLICATIONS
The first implication for future marketing efforts is that FDA is reiterating that risk information must bepresented at the same time in the same location as benefit information related to a product.Second, companies with more than one product in a treatment category who wish to make site visitors awareof multiple products must ensure that risk information is provided for each specific product whose benefitsare discussed. In the context of a discussion of comorbidities or risk factors, it would be difficult to includeany product names without implying a benefit. Consequently, any mention of a product name in such contextshould be assumed to require presentation of risk information. This will be particularly relevant to anyfranchise marketing efforts that promote a company’s entire product line within a therapeutic area.
RECOMMENDATIONS
1.
Review existing and planned discussions of comorbidities on product sites. Ensure there isno explicit mention of products and indications (either complete or abbreviated) without materialrisk information.
September 13, 2011Regulatory Alert: FDA Enforcement Action on Comorbidity & Linking StrategiesPage2 of 4
 
2.
Linking strategies to product pages should avoid mention of the product name withinformation about the indication unless sufficient risk information is provided.
In context of comorbidities or the treatment of additional risk factors, special care should be taken.3.Product sponsors must take into account the extensive reporting of allegedly violativepractices by health care professionals as reports from the Bad Ad Program constitute nearly 25% of all enforcement actions taken in 2011.
SUPPLEMENTAL MATERIAL
Bad Ad Program Information on the FDA website:http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/DrugMarketingAdvertisingandCommunications/ucm209384.htmWarning Letters from 2011 (including the letter discussed in this alert) on the FDA website:http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm238583.htm#DDMAC
ENDNOTES
September 13, 2011Regulatory Alert: FDA Enforcement Action on Comorbidity & Linking StrategiesPage3 of 4

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