Will Rem OK put an end to EUAs in US?
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Posted On: 10/22/2020 8:54:29 PM
Taken from a MSM article on the f'nda's approval of gilead's junk science:
Merdad Parsey, Gilead's chief medical officer, said in an open letter Thursday that the data from the WHO trial "does not negate other study results," like those from the NIH trial.
And Francisco Marty, an infectious disease doctor at Brigham and Women's Hospital in Boston who worked on a Gilead-sponsored trial of remdesivir, said the data from the NIH trial was better quality than that from the WHO trial, "and it was done in the U.S."
The FDA, which normally convenes an independent advisory committee to review drugs prior to approval if there are questions about a treatment's efficacy or safety, did not do so for remdesivir. The agency said it was not necessary because Gilead's application for approval "did not raise significant safety or efficacy issues."
Background: The FDA has approved the use of remdesivir in adults and children over age 12 who are hospitalized with Covid-19.
The agency gave the drug an emergency-use authorization in May after preliminary data from the government trial, run by NIH's National Institute of Allergy and Infectious Diseases, showed that remdesivir cut the length of hospital stays.
Since then, thousands of patients — including President Donald Trump — have taken the drug.
Sweetening the deal: As part of its approval, the FDA awarded Gilead a priority review voucher that it can use or sell to other companies to speed the review of another drug. Remdesivir qualified for the voucher because the agency considers it a medical countermeasure to a material threat — in this case, the virus.
The voucher is potentially worth about $100 million.
Ripple effects? The approval for remdesivir could have wider implications for other potential Covid-19 treatments.
Gellad said that the approval could prevent the FDA from issuing emergency-use authorizations for other coronavirus treatments for hospitalized patients. That's because the agency can noly issue an EUA when no approved therapy is available.
But Rachel Sachs, an associate professor of law at Washington University in St. Louis, said she thinks it's unlikely as "the legal standards ('adequate,' 'available,' etc) leave room for more authorizations, especially for products that have different mechanisms of action or indications."
Merdad Parsey, Gilead's chief medical officer, said in an open letter Thursday that the data from the WHO trial "does not negate other study results," like those from the NIH trial.
And Francisco Marty, an infectious disease doctor at Brigham and Women's Hospital in Boston who worked on a Gilead-sponsored trial of remdesivir, said the data from the NIH trial was better quality than that from the WHO trial, "and it was done in the U.S."
The FDA, which normally convenes an independent advisory committee to review drugs prior to approval if there are questions about a treatment's efficacy or safety, did not do so for remdesivir. The agency said it was not necessary because Gilead's application for approval "did not raise significant safety or efficacy issues."
Background: The FDA has approved the use of remdesivir in adults and children over age 12 who are hospitalized with Covid-19.
The agency gave the drug an emergency-use authorization in May after preliminary data from the government trial, run by NIH's National Institute of Allergy and Infectious Diseases, showed that remdesivir cut the length of hospital stays.
Since then, thousands of patients — including President Donald Trump — have taken the drug.
Sweetening the deal: As part of its approval, the FDA awarded Gilead a priority review voucher that it can use or sell to other companies to speed the review of another drug. Remdesivir qualified for the voucher because the agency considers it a medical countermeasure to a material threat — in this case, the virus.
The voucher is potentially worth about $100 million.
Ripple effects? The approval for remdesivir could have wider implications for other potential Covid-19 treatments.
Gellad said that the approval could prevent the FDA from issuing emergency-use authorizations for other coronavirus treatments for hospitalized patients. That's because the agency can noly issue an EUA when no approved therapy is available.
But Rachel Sachs, an associate professor of law at Washington University in St. Louis, said she thinks it's unlikely as "the legal standards ('adequate,' 'available,' etc) leave room for more authorizations, especially for products that have different mechanisms of action or indications."
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