For The Defense, October 2010 - DRI Today

D R U G A N D M E D I C A L D E V I C Ebe shorter and use less complex languagethan a drug’s professional labeling. Patientpackage inserts are intended for a differentaudience. If you question a plaintiff about apatient package insert during a deposition,ask the plaintiff specifically to identify anythinghe or she claims that he or she did notunderstand about the risks discussed in theinsert or the particular words that he or sheA patient packageinsert… literally puts riskinformation and warnings ina patient’s hands every timea patient fills a prescription.found confusing. Ask the plaintiff if he orshe called his or her doctor or pharmacistfor clarification.Once approved, a patient package insertmay be used with printed advertisementsfor the drug. See Ctr. for Drug Evaluation& Research, U.S. Food & Drug Admin.,Consumer Medication Information (CMI):Expert and Consumer Evaluation of ConsumerMedication Information 2008:Questions and Answers, http://www.fda.gov/AboutFDA/CentersOffices/CDER/ReportsBudgets/ucm163786.htm. When a plaintiff claims thata drug advertisement in a magazine eitherconvinced him or her to start taking a drugor offered “reassurance” that continuing totake the drug was a good idea, ask if he orshe read the entire advertisement. At trial,be prepared to introduce an authenticatedcopy of the entire document, which shouldinclude the patient package insert.40 n For The Defense n October 2010Medication GuidesPlaintiffs often admit that they received“printouts” or “flyers” from pharmacieswith their prescriptions. In many cases,they are describing a FDA- approved “medicationguide” created by the manufacturer.The FDA may determine that certainprescription drugs and biological products“pose a serious and significant publichealth concern” that makes a written,patient- oriented medication guide “necessaryto patients’ safe and effective use” ofthe product. 21 C.F.R. §208.1(a)–(b). TheFDA can require a medication guide in oneof three circumstances: (1) patient labelingmay help prevent serious adverse effects,(2) a drug has serious risks that patientsshould weigh against its benefits in decidingto use the drug, or (3) a drug is considered“important to health” and patientadherence to directions for use is criticalto the drug’s effectiveness. 21 C.F.R.§208(1)(c).Among other things, a medication guideis• Written in “non- technical, understandable”English;• Legible and clearly presented;• Not promotional in tone or content;• Scientifically accurate and consistentwith the professional labeling; and• Specific and comprehensive.21 C.F.R. §208.20(a). The regulations furtherspecify the formatting and requiredcontent of a medication guide. 21 C.F.R.§208.20(b).Because the primary objective of a medicationguide is to ensure that a patient iswell- advised of the risks associated withthe medication, risks are discussed inseveral different sections and subheadingsof a medication guide. See 21 C.F.R.§208.20(b)(2) (“What is the most importantinformation I should know about”the drug); 21 C.F.R. §208.20(b)(4) (“Whoshould not take” the drug); 21 C.F.R.§208.20(b)(6) (“What should I avoid whiletaking” the drug); 21 C.F.R. §208.20 (b)(7)(“What are the possible or reasonably likelyside effects of” the drug). Note that, interms of the section describing likely sideeffects, a medication guide must describeadverse “reactions that are likely to becaused by the drug product that are seriousor occur frequently.” 21 C.F.R. §208.20(b)(7)(i) (emphasis added).While a drug manufacturer is responsiblefor preparing and obtaining FDAapproval of a medication guide beforedistribution, medication guides are distributedto consumers by pharmacies, or“dispensers” or “distributors.” See 21 C.F.R.§208.24. A patient should receive a medicationguide with a new prescription andwith each refill.Medication guides were not intendedto be ubiquitous. When the final ruleestablishing medication guides went intoeffect in 1998, the FDA expected that “nomore than 5 to 10 products per year wouldrequire such information.” PrescriptionDrug Product Labeling: Medication GuideRequirements; Final Rule, 63 Fed. Reg.66479 (Dec. 1, 1998). However, in 2005, theFDA began approving classwide medicationguides. As a result, medication guidesare currently available for more than 200prescription medications and over thecounter drugs, including antidepressants,nonsteroidal anti- inflammatory drugs(NSAIDs), narcotic pain relievers, attentiondeficit hyperactivity disorder (ADHD)medications, and certain antibiotics. SeeU.S. Food & Drug Admin., MedicationGuides, http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm (listing currently availablemedication guides, including .pdf images)(last visited Sept. 2, 2010).Risk Evaluation and Mitigation StrategiesThe FDA’s risk evaluation and mitigationstrategies (REMS) may be another avenuethrough which consumers receive warningsabout the risks associated with prescriptionpharmaceuticals. REMS arosefrom a new section, 505-1, of the Food,Drug, and Cosmetic Act (FDCA), under theFood and Drug Administration AmendmentsAct of 2007, which went into effectin October 2009. In September 2009 theFDA issued a draft guidance, “Format andContent of Proposed Risk Evaluation andManagement Strategies (REMS), REMSAssessments, and Proposed REMS Modifications.”U.S. Food & Drug Admin.,http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM184128.pdf (Sept. 30, 2009).The draft guidance provides a blueprintfor developing and implementing REMS.Although the REMS provisions took effectonly recently, the FDA’s website currentlylists over 100 pharmaceutical products thathave been subject to and for which it hasapproved REMS.The FDA may require REMS for anydrug or biological product subject to a newdrug application (NDA), abbreviated newdrug application (ANDA), or therapeuticbiologic application (BLA) at any timeif it determines that (1) “new safety information”comes to light, and (2) it is necessaryto make certain that the benefits of