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Rice BIOE 301 - Lecture Notes

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BIOE 301FDAHistory of RegulationTodaySlide 5Post-Marketing SurveillanceRegulation of Medical Devices19761976: Device amendments to FD&C ActRole of CDRHDevice Approval ProcessIDEHumanitarian Use ExemptionMedical Device ReportingRecently Approved DevicesWho Funds R&D? Who Does R&D?Types of UniversitiesTotal Research Expenditures @ RiceR&D Funding for Biomedical ResearchUS Senate Report – May, 2000NIHThe Funding ProcessBIOE 301Lecture Twenty-TwoFDARegulates products whose annual sales account for ¼ of consumer spending in USResponsible for ensuring SAFETY and EFFICACY of CHEMICAL, BIOLOGICAL agents and sophisticated medical DEVICESSafe:Probable benefits to health for intended use outweigh any probable risk of harm Effective:Device does what it is supposed to do in a reliable fashionHistory of Regulation1906Food and Drug ActCan’t lie on label1938Food, Drug and Cosmetic ActPremarket notification1962Drug amendments to FD&C ActPremarket approval1976Medical Device Amendments to FD&C Act1994Dietary Supplement Health Education ActTodayCANNOT mention diseaseCAN make claims that food can affect structure of function of bodyExamples:CANNOT say that a product reduced cholesterol but CAN say it maintains healthy cholesterol levelsCANNOT say echinacea cures disease, but CAN say it has natural antibiotic activities and is considered an excellent herb for infections of all kindsPost-Marketing SurveillanceVioxx – withdrawn from marketCelebrex – black box warningBextra – sales suspendedhttp://www.fda.gov/medwatch/ http://www.npr.org/templates/story/story.php?storyId=4500447 http://www.npr.org/templates/story/story.php?storyId=5229443 http://www.npr.org/templates/story/story.php?storyId=5336272Regulation of Medical DevicesFDA did not regulate devices before 19381938:FDA could only challenge sale of products it believed were unsafeCould only remove them from the market after patient injuries1960s:Rapid innovation in medical technologyTried to regulate many as drugs: contact lenses, IUDsCatastrophic failures of heart valves and pacemakers1970s:Broad recognition that different rules were needed to regulate devices1976Device amendments to FD&C Act:No single policy would work for all devicesTongue depressorArtificial heart1976: Device amendments to FD&C ActThree classes of devices:Class I: Pose least risk to patientNot life sustainingGMP, proper record keeping required 30% of devicesX-ray film, tongue depressors, stethoscopesClass II: Not life sustaining, but must meet performance standardsBlood pressure monitors, Catheter guide wires60% of devicesClass III: Pose greatest risk to patient For use in supporting or sustaining human life10% of devicesStents, heart valves, LVADsRequire GMP, failure modes analysis, animal tests, human clinical studies under IDERole of CDRHEnsure that products coming to market have more benefit than riskEnsure that products are labeled so that practitioners and patients know what to expect from their useRegulates 1,700 types of devices23,000 registered manufacturers1996: received 20,236 device related submissionsDevice Approval ProcessDevice + intended use considered togetherManufacturer submits request for marketing approvalAdvisory panel:One consumer representative (non-voting)One industry representative (non-voting)Physicians and scientistsFDA not required to follow recommendations of panel, although they usually doIDEInvestigational Device ExemptionEnables experimental use of high risk deviceMust have positive engineering and animal data First give approval for feasibility studies with small number of patientsThen proceed to multi-center trials Larger data sets frequently show results from small sample sets are not trueHumanitarian Use ExemptionDevice designed to treat or diagnose condition that affects <4,000 patients/yearDevice would not otherwise be available without exemptionNo comparable device is availablePatients will not be exposed to unreasonable or significant risk of injury or illness by deviceMedical Device ReportingSystem to detect device related problems in a timely mannerSerious injuries or deaths that may have been caused by or related to a a medical device must be reported to the manufacturer of the device within 10 daysMust be reported to the FDA within 10 daysRecently Approved Deviceshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/MDA/mda-list.cfm?list=1NIRflex Stent Systemhttp://www.fda.gov/cdrh/mda/docs/p020040.html http://www.medinol.com/nirflex.html http://www.fda.gov/cdrh/PDF2/P020040a.pdf http://www.fda.gov/cdrh/PDF2/P020040.htmlWho Funds R&D? Who Does R&D?http://www.nsf.gov/sbe/srs/seind02/c4/fig04-12.gifTypes of UniversitiesCarnegie ClassificationTaxonomy of colleges and universities Doctorate-Granting InstitutionsResearch Universities /Very High Research ActivityResearch Universities/ High Research ActivityDoctoral/Research UniversitiesMaster’s Colleges & UniversitiesBaccalaureate Colleges http://www.carnegieclassification-preview.org/index.aspx RiceTotal Research Expenditures @ RiceR&D Funding for Biomedical ResearchFederal government:Funds ~ 36% of all medical research in USMostly funded through NIH:Current NIH budget: $28 billion/yearNIH budget doubled from 1998-2003This year: 0% increase Focus is on basic researchUS Senate Report – May, 200021 drugs introduced between 1965 and 1992: Considered by experts to have had highest therapeutic impact on society Public funding of research was instrumental in development of 15 of the 21 drugs (71%)Three-captopril (Capoten), fluoxetine (Prozac), and acyclovir (Zovirax)-had more than $1 billion in sales in 1994 and 1995Others, including AZT, acyclovir, fluconazole (Diflucan), foscarnet (Foscavir), and ketoconazole (Nizoral), had NIH funding and research to help in clinical trialsNIHNational Cancer InstituteNational Eye InstituteNational Heart, Lung, and Blood InstituteNational Human Genome Research InstituteNational Institute on AgingNational Institute on Alcohol Abuse and AlcoholismNational Institute of Allergy and Infectious DiseasesNational Institute of Arthritis and Musculoskeletal and Skin DiseasesNational


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