Great to see new attention to this study showing unintended consequences to #FDA's Unapproved Drugs Initiative - also a great example of how #HealthServicesResearch can contribute to policy change, since the UDI was terminated in 2020, citing this work: https://www.govinfo.gov/content/pkg/FR-2020-11-25/pdf/2020-26133.pdf #HealthPolicy #RxPolicy
QT @iwashyna
ok, like half of the useful non-antibiotic #ICU #drugs are apparently #UnapprovedByFDA
Source: #RaviGupta #JoeRoss in https://pubmed.ncbi.nlm.nih.gov/28944731/
"Specific manufacturers that received direct FDA warning letters also were found to have raised prices after obtaining approval for drug products they had already marketed without approval. In addition, all but 2 drugs that received new approval through voluntary compliance or after UDI regulatory action were supported by literature reviews and bioequivalence to older drug products, not new clinical trial evidence"
Source: https://pubmed.ncbi.nlm.nih.gov/28944731/ #Drugs #Pharma #DrugShortage
This project was not supported by any external grants or funds. Gupta was supported by the Yale University School of Medicine Office of Student Research at the time of this study. Dhruva is supported by the Department of Veterans Affairs as part of the Robert Wood Johnson Foundation Clinical Scholar β¦
ok, like half of the useful non-antibiotic #ICU #drugs are apparently #UnapprovedByFDA
Source: #RaviGupta #JoeRoss in https://pubmed.ncbi.nlm.nih.gov/28944731/
#WTF
#atropine #epinephrine #hydrocodone #levothyroxine #morphine #nitroglycerine #oxycodone #pancrelipase #phenylephrine #vasopressin
This project was not supported by any external grants or funds. Gupta was supported by the Yale University School of Medicine Office of Student Research at the time of this study. Dhruva is supported by the Department of Veterans Affairs as part of the Robert Wood Johnson Foundation Clinical Scholar β¦
#RaviGupta pointing out there is a #DrugShortage #Database
"U.S. Drug Shortages
We used the University of Utahβs Drug Information Service drug shortage database from January 1, 2004, to December 31, 2015. A shortage is defined as a supply issue that affects how a pharmacy prepares or dispenses a drug product that influences patient care when prescribers must use an alternative agent.26...
ok, more #JohnsHopkins #RaviGupta on #DrugInsanity #pharma
"The FDA estimated that approximately 2% of all prescriptions dispensed in the United States in 2006 may have been for drug products lacking FDA approval"
https://pubmed.ncbi.nlm.nih.gov/28944731/
Including things like #hydrocodone and #SublingualNitroglycerine
Where's #Twitterx #Pharmastodon at?
This project was not supported by any external grants or funds. Gupta was supported by the Yale University School of Medicine Office of Student Research at the time of this study. Dhruva is supported by the Department of Veterans Affairs as part of the Robert Wood Johnson Foundation Clinical Scholar β¦
Reading my new #JohnsHopkins colleague #RaviGupta's paper on new drug formulations in #JAMAHealthForum
https://pubmed.ncbi.nlm.nih.gov/35977259/
Levels of devious #pharma and clever data
Devious + #NewToMe: #Evergreening #ProductHopping
Super Cool #data: #DrugInnovativeness and #Prescrire
In this cross-sectional study of novel drugs in tablet or capsule form approved by the FDA between 1995 and 2010, manufacturers pursued new formulations of best-selling brand-name drugs and those granted accelerated approval but did so less frequently once generic competitors entered the market. Oth β¦
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Audrey D. Zhang
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