11/9 Pharma & Tech
Thursday, October 6, 2022
17:20
Background Definitions Drug: chemical cmpds for cure/treatment/prevention of disease . Biologicals: vaccines, blood components, stem cells, recombinant proteins, antibodies, gene therapy . Device: -"an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article...,. FDA
Deput
The Executive Secretariat
ntal anc
office
nolog
Operating Divisions
Office of the Assistant Secretary for Administration
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for Legislation
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F22 Page 32
Food and Drug Administratior
September 2021
Office of the Commissioner
Commissioner of Food&Drugs Janet Woodcock,MD(Acting
Principal Deputy Commisioner Vacant
Julia Tiemey (Acting)
DCA
ood Safet Appl
Diredor
MD.Ph
FDA Approval FDA serves to ensure that drugs/pharmaceuticals (chemical drugs and also biologics) are safe and effective- not that one is better than the current options Uses clinical trial data- but by those who performed the trial Examines effectiveness against disease of interest- but only for that disease (investigates only 1 indication) Track risks of drug/biologic Manages drug safety in production (drugs not contaminated, factories safe, ensure that dose is correct, shelf life is correct, etc.) FDA approval is very clear in what the drug is approved for; doesn't mean the drug is more effective than current drugs on the market for the same thing o Once drug is approved, company can advertise it Only counts for the US, but other countries' regulatory bodies can grant reciprocity (if FDA approved, this country will approve) o However, the FDA doesn't have a lot of reciprocity from other countries' approvals
to do in other countries) Much of the research on a drug is being done by academic physicians and the healthcare system, not the pharma company itself. The pharmaceutical agency sponsors the cost of the clinical trial, but they are underpaid. Thus, institution carries burden of the difference. Cost gets pushed down to basic care delivery and onto people not enrolled in clinical trials o Much of the innovation is actually happening in academia (e.g., car-T cell therapy on leukemia) Car-T cells: extract T cells from pt via phoresis, use a genetically-modified vector to add an antibody specific to CD-19, which leukemia cells express. You then reinfuse these T cells into pt. This research was done in academic hospitals o Novartis bought out this process, streamlined it, and said the price is $890k/dose. They charge closer to $1.5mn/dose. Novartis is profiting off the work academia did. Thus, innovation is happening in academia and not these companies. Special Approvals Accelerated appr