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US Food and Drug Administration: c000006

US Food and Drug Administration: c000006

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Published by: FDA on Jan 23, 2008
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Board of Directors
Linda F. Golodner
L&and H. Swenson
Jane King
Vice Chair
Esther Shapiro
Vice Chair
Don RoundsTreUSUWTheodore R. Debro, Jr.Secre&ryTack BlumRobert R. Nathan
Honorary Chair
Erma Angevine
Honorary President
Esther Peterson (1906-1997)
Honorary President
Morton BahrDebra BetlynAlan BoschJames BrownElizabeth BunnSommer K. ClarkeJim ConranEvelyn DubrowGlenn EnglishMary FingerDorothy GarrickPastor Herrera, Jr.Mary HeslinArlene H&-BakerRuth JordanHarry KranzRobert N. MayerJoyce
MillerLarry MitchellCarl OshiroBrandolyn T. Clanton PinkstonAlma Morales RiojasTracey L. DeYampert RogersPhyllis RowePatricia RoyerBert SeidmanSamuel A. SimonCaroline StellmannRicki StochajPatricia Tyson
Barbara Van
BlakeGladys Gary VaughnClinton WarneLot-a WeberFrances WestBetsy Woodward
1701 K Street, NW, Suite 1200, Washington, DC 20006“o‘i “‘Z ?
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(2b‘2) 835-3323
(202) 835-0747
July 19,200lDockets Management Branch(HFA - 305)Food and Drug Administration5630 FishersLaneRoom 1061Rockville, MD 20852Re:Docket No. OlD-0162; Draft Guidance for TndustrvonUsing FDA-Approved Patient Labeling in Consumer-Directed Print AdvertisementsDear Sir or Madame:The National ConsumersLeague (NCL) appreciates his opportunity tocomment on the Food and Drug Administration’s (FDA) Draft Guidance for Industryon Using FDA-Approved Patient Labeling in Consumer-Directed PrintAdvertisements. Draft Guidance for Industry on Using FDA-Approved PatientLabeling In Consumer-Directed Print Advertisements, 66 Fed. Reg. 20468 (April 23,200 1). NCL is a national nonprofit consumer advocacy organization founded in1899 to represent consumers n the marketplace and the workplace. NCL welcomesFDA’s efforts to improve the quality of the information about prescription drugproducts directed to consumers.NCL has been involved with the issuessurrounding prescription drugadvertising for many years.NCL offered testimony at the FDA’s public hearing ondirect-to-consumer (DTC) promotion in 1995. NCL has also conducted research ntoconsumer perceptions and the impact of prescription drug promotion.In January 1996 and again in September 1998, NCL invited stakeholders oroundtable meetings to discussDTC promotion.The goal of these roundtables wasto reach some consensuson various aspectsof this issue. FDA participated in theseroundtables as an “observer.” We distributed reports on these roundtable discussionsto FDA and others. Copies of the reports of NCL Roundtables I and II are attached.Among the conclusions drawn from the roundtables:While DTC promotion benefits consumersby providing themwith information about the availability and characteristics ofdrugs they might not have otherwise known, it ismore effective in communicating benefits than risks..
Letter to Dockets Management BranchJuly 19,200lPage 2DTC promotion can convey only a limited amount of informationdue to time and spaceconstraints; additional information sourcesoffering balanced nformation must be available to consumers.For print advertising, most brief summariesdo not convey usefulinformation to consumersand the requirements should be reformedto assure hat the information conveyed s less detailed and moreconsumer friendly.Brief summariesshould be re-formatted to better provide importantusage and safety information in consumer-friendly language. Thebrief summary should reflect the recommendationsof the 1996Keystone Committee and include the most serious and mostfrequent side effects and information about the disease he drug isintended to treat and what the drug does and does not do.Health care professionals should receive different messageshanconsumersdo.DTC promotion should not be false or misleading, should be fairlybalanced, may refer consumers o other sources or furtherinformation.DTC promotion is a component to empowering consumerswith information about theprescription drugs they use. Advertising can inform consumersabout goods and services n themarketplace, ncluding even products as potent as prescription drugs. To fulfill this vital role,however, prescription drug promotion must be fairly balanced and adequately nform consumersof the risks of drugs to avoid misuse, noncompliance, and adverseeffects. With balanced, clearinformation, most consumerscan understand and evaluate drug benefit claims and form accurateopinions about prescription drugs.The healthcare environment has changed dramatically in recent years and this trend willcontinue. Today, a physician ,isnot the only or even necessarily, he primary, source forinformation about a patient’s own health care. Patients gather information through the mediaand Internet, from family and friends, and in their workplace.Consumersmay not alwaysdevelop close relationships with their physicians when they are receiving their medical carethrough clinics, emergency ooms, and managed-caresystems.Still, even amidst these changes, t is health care professionals who are responsible orensuring that consumersunderstand how to safely and effectively use drugs. Only the healthprofessional can evaluate whether the drug is appropriate for a particular patient.The healthprofessional must discuss he risks and benefits of medications and other treatment options withthe patient. The patient should also take responsibility for personal health decisions. NCL
Letter to Dockets Management BranchJuly 19,200lPage 3encouragesstronger relationships between patients and their physicians, pharmacists,nurses,and other healthcare professionals.In 1995, NCL commendedFDA for its commitment to aiding this dialogue aboutprescription and over-the-counter drugs between professionals and consumers. We do so againtoday. Allowing drug advertisers o fulfill the brief summary requirement by providing FDA-approved patient labeling will improve the quality and comprehensionof information flowing topatients. NCL urges FDA to adopt the Draft Guidance quickly.In 1995, NCL also reminded FDA that the existing regulations on the DTC promotion ofprescription drugs were outmoded and not helpful to consumers. NCL urged FDA to adopt newstandardsspecifically for prescription drug advertising directed to the consumer, rather than tothe health care professional. Similar recommendationscame out of the 1996 and 1998roundtables. NCL repeats his call again.The current regulations are ill-suited to communicate mportant risk information toconsumers. While DTC promotion is usually quite good at communicating a product’s benefits,it is less effective in communicating a drug’s risks. The best DTC promotion is not necessarilythe one that is the most exhaustive n its recitation of risk information. The brief summaries(and, with this Draft Guidance, the FDA-approved patient labeling) that accompany printadvertising are quite comprehensiveand often complex. They are also generally presented nvery small type. They are often written in technical language only a medical professional wouldunderstand. They are formatted so that it is difficult for a consumer o distinguish the likelihoodand severity of adverseevents. These documents may recite all of a drug’s risk information;however most patients cannot and do not read it, and if they do so, many cannot understand whatthey read.The current regulatory scheme s especially difficult for those with limited reading andcomprehensionabilities. Those with limited education and people whose first language s notEnglish are particularly vulnerable. The elderly, who take most of the prescription drugs, oftencannot read the very small print. In this respect, he Draft Guidance is a positive step, but doesnot go far enough. FDA-approved patient labeling is very detailed. When condensed nto aformat that can fit on a single page for a print advertisement,patient labeling is likely to appearmuch as the current brief summary does -- dense, ong, and technical.Above all, risk information must be presented n a format and language hat is consistent,useful, and easy or the consumer o read and understand.Regulations that mandate differentpresentationsof the same isk information in varying levels of detail do not serve consumerswell. For instance, whether a consumer receives a brief summary or full package abeling for adrug should not turn on whether the promotion triggering the disclosure s deemed advertising orpromotional labeling. In NCL’s view, the format for presenting risk information for prescriptiondrugs should be standardized,as it is for over-the-counter drugs, dietary supplementsand foods.The “Drug Facts,“Supplement Facts” and “Nutrition Facts” formats provide excellent modelsfor the presentation of important risk and usage nformation for prescription drugs.It is a formatthat consumersare now familiar with and one that has helped them make informed choices forthese products.

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