The commissioner of the Food and Drug Administration, Stephen Hahn, quickly clarified that the agency had not in fact approved the drug as a safe and effective treatment for the new disease, shortly after the president claimed that the drug was "Approved very, very quickly and it's now approved by prescription."
The confusion over chloroquine-along with the broader performance of U.S. regulatory agencies during this epidemic-highlights how our federal process for reviewing and approving drugs and medical devices still leaves much to be desired.
After an innovator submits an Investigational New Drug application, the FDA requires a three-stage testing process, then the submission of a formal New Drug Application that typically includes hundreds of thousands of pages of documentation.
Once the FDA has approved a pharmaceutical compound as safe and effective for a particular use, doctors can prescribe the drug for an alternative use that has not been run through the full FDA review-commonly called "Off-label" drug prescription.
Off-label drug prescription is particularly common in emergency settings: a 2011 study in the Journal of Critical Care found that 36 percent of all drugs used in intensive-care units are for off-label indications.
Scientists have been testing scores of drugs approved for other uses for efficacy in treating the new disease.
The 1992 Prescription Drug User Fee Act has helped facilitate getting some drugs to market more quickly.
https://www.city-journal.org/government-regulation-exacerbated-covid-19-crisis
The confusion over chloroquine-along with the broader performance of U.S. regulatory agencies during this epidemic-highlights how our federal process for reviewing and approving drugs and medical devices still leaves much to be desired.
After an innovator submits an Investigational New Drug application, the FDA requires a three-stage testing process, then the submission of a formal New Drug Application that typically includes hundreds of thousands of pages of documentation.
Once the FDA has approved a pharmaceutical compound as safe and effective for a particular use, doctors can prescribe the drug for an alternative use that has not been run through the full FDA review-commonly called "Off-label" drug prescription.
Off-label drug prescription is particularly common in emergency settings: a 2011 study in the Journal of Critical Care found that 36 percent of all drugs used in intensive-care units are for off-label indications.
Scientists have been testing scores of drugs approved for other uses for efficacy in treating the new disease.
The 1992 Prescription Drug User Fee Act has helped facilitate getting some drugs to market more quickly.
https://www.city-journal.org/government-regulation-exacerbated-covid-19-crisis
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