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-TwoFDARegulates products whose annual sales account for ¼ of consumer spending in USResponsible for ensuring SAFETY and EFFICACY of CHEMICAL, BIOLOGICAL agents and sophisticated medical DEVICESSafe: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 Regulation1906Food and Drug ActCan’t lie on label1938Food, Drug and Cosmetic ActPremarket notification1962Drug amendments to FD&C ActPremarket approval1976Medical Device Amendments to FD&C Act1994Dietary Supplement Health Education ActTodayCANNOT mention diseaseCAN make claims that food can affect structure of function of bodyExamples:CANNOT say that a product reduced cholesterol but CAN say it maintains healthy cholesterol levelsCANNOT say echinacea cures disease, but CAN say it has natural antibiotic activities and is considered an excellent herb for infections of all kindsPost-Marketing SurveillanceVioxx – withdrawn from marketCelebrex – black box warningBextra – sales suspendedhttp://www.fda.gov/medwatch/ http://www.npr.org/templates/story/story.php?storyId=4500447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 DevicesFDA did not regulate devices before 19381938:FDA could only challenge sale of products it believed were unsafeCould only remove them from the market after patient injuries1960s:Rapid innovation in medical technologyTried to regulate many as drugs: contact lenses, IUDsCatastrophic failures of heart valves and pacemakers1970s:Broad recognition that different rules were needed to regulate devices1976Device amendments to FD&C Act:No single policy would work for all devicesTongue depressorArtificial heart1976: Device amendments to FD&C ActThree classes of devices:Class I: Pose least risk to patientNot life sustainingGMP, proper record keeping required 30% of devicesX-ray film, tongue depressors, stethoscopesClass II: Not life sustaining, but must meet performance standardsBlood pressure monitors, Catheter guide wires60% of devicesClass III: Pose greatest risk to patient For use in supporting or sustaining human life10% of devicesStents, heart valves, LVADsRequire GMP, failure modes analysis, animal tests, human clinical studies under IDERole of CDRHEnsure that products coming to market have more benefit than riskEnsure that products are labeled so that practitioners and patients know what to expect from their useRegulates 1,700 types of devices23,000 registered manufacturers1996: received 20,236 device related submissionsDevice Approval ProcessDevice + intended use considered togetherManufacturer submits request for marketing approvalAdvisory panel:One consumer representative (non-voting)One industry representative (non-voting)Physicians and scientistsFDA not required to follow recommendations of panel, although they usually doIDEInvestigational Device ExemptionEnables experimental use of high risk deviceMust have positive engineering and animal data First give approval for feasibility studies with small number of patientsThen proceed to multi-center trials Larger data sets frequently show results from small sample sets are not trueHumanitarian Use ExemptionDevice designed to treat or diagnose condition that affects <4,000 patients/yearDevice would not otherwise be available without exemptionNo comparable device is availablePatients will not be exposed to unreasonable or significant risk of injury or illness by deviceMedical Device ReportingSystem to detect device related problems in a timely mannerSerious 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 daysMust be reported to the FDA within 10 daysRecently Approved Deviceshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/MDA/mda-list.cfm?list=1NIRflex Stent Systemhttp://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 UniversitiesCarnegie ClassificationTaxonomy of colleges and universities Doctorate-Granting InstitutionsResearch Universities /Very High Research ActivityResearch Universities/ High Research ActivityDoctoral/Research UniversitiesMaster’s Colleges & UniversitiesBaccalaureate Colleges http://www.carnegieclassification-preview.org/index.aspx RiceTotal Research Expenditures @ RiceR&D Funding for Biomedical ResearchFederal government:Funds ~ 36% of all medical research in USMostly funded through NIH:Current NIH budget: $28 billion/yearNIH budget doubled from 1998-2003This year: 0% increase Focus is on basic researchUS Senate Report – May, 200021 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 1995Others, including AZT, acyclovir, fluconazole (Diflucan), foscarnet (Foscavir), and ketoconazole (Nizoral), had NIH funding and research to help in clinical trialsNIHNational Cancer InstituteNational Eye InstituteNational Heart, Lung, and Blood InstituteNational Human Genome Research InstituteNational Institute on AgingNational Institute on Alcohol Abuse and AlcoholismNational Institute of Allergy and Infectious DiseasesNational Institute of Arthritis and Musculoskeletal and Skin DiseasesNational
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