Biden administration limits use of two monoclonal antibody treatments

[Right_in_Virginia]

Biden administration limits use of two monoclonal antibody treatments
The Hill, Jan 24, 2022

The Food and Drug Administration (FDA) on Monday significantly restricted the use of a pair of monoclonal antibody treatments for COVID-19 because they are ineffective against the omicron variant.

The agency said the therapies made by Eli Lilly and Regeneron should only be used in patients that have been infected with or exposed to a variant that is susceptible to the treatments.

"Because data show these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States, these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time," the FDA said.

"In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions," the FDA said.

https://thehill.com/policy/healthcare/591129-biden-administration-limits-use-of-two-monoclonal-antibody-treatments

[Right_in_Virginia]

FDA Closes Monoclonal Antibody Clinics In Florida, DeSantis Seeks Reversal
Washington Examiner, Jan 25, 2022

Monoclonal antibody sites throughout Florida will be closed after the Food and Drug Administration adjusted its authorization for the COVID-19 treatment.

The new FDA policy only allows those "likely to have been infected with or exposed to a variant that is susceptible to these treatments" to receive the new medication, despite Florida's leadership advocating for its use among the populace.

"This indefensible edict takes treatment out of the hands of medical professionals and will cost some Americans their lives," Florida Gov. Ron DeSantis said in a Monday statement. "There are real-world implications to Biden's medical authoritarianism — Americans' access to treatments is now subject to the whims of a failing president."

DeSantis is demanding that the Biden administration reverse the decision.

The FDA says that its reversal of the treatment's authorization is because the treatments are "highly unlikely to be active against the omicron variant," which was considered the dominant strain at one point.

"Florida disagrees with the decision that blocks access to any available treatments in the absence of clinical evidence," the state health department said in a press release.


More:  https://www.washingtonexaminer.com/news/fda-florida-monoclonal-antibodies

[libertybele]

FDA Closes Monoclonal Antibody Clinics In Florida, DeSantis Seeks Reversal
Washington Examiner, Jan 25, 2022

Monoclonal antibody sites throughout Florida will be closed after the Food and Drug Administration adjusted its authorization for the COVID-19 treatment.

The new FDA policy only allows those "likely to have been infected with or exposed to a variant that is susceptible to these treatments" to receive the new medication, despite Florida's leadership advocating for its use among the populace.

"This indefensible edict takes treatment out of the hands of medical professionals and will cost some Americans their lives," Florida Gov. Ron DeSantis said in a Monday statement. "There are real-world implications to Biden's medical authoritarianism — Americans' access to treatments is now subject to the whims of a failing president."

DeSantis is demanding that the Biden administration reverse the decision.

The FDA says that its reversal of the treatment's authorization is because the treatments are "highly unlikely to be active against the omicron variant," which was considered the dominant strain at one point.

"Florida disagrees with the decision that blocks access to any available treatments in the absence of clinical evidence," the state health department said in a press release.


More:  https://www.washingtonexaminer.com/news/fda-florida-monoclonal-antibodies

This is absolutely disgraceful and Joe WILL continue to have blood on his hands. He has no conscience (and neither does the one pulling his strings).

[Right_in_Virginia]

REPORTER: "Florida continues to push for [monoclonal antibody] treatment ... What's your response to Gov. DeSantis?"

PSAKI: "Let's just take a step back here just to realize how crazy this is ... We know what works, vaccines and boosters."

(Video)

https://mobile.twitter.com/Breaking911/status/1486056528356515847

[Right_in_Virginia]

This is absolutely disgraceful and Joe WILL continue to have blood on his hands. He has no conscience (and neither does the one pulling his strings).

This is criminal, IMO.  It's a political move designed to harm citizens.

[Right_in_Virginia]

Ron DeSantis
@GovRonDeSantis

Without a shred of clinical data to support its decision, the Biden Administration has revoked the emergency use authorization for lifesaving monoclonal antibody treatments.

8:50 AM · Jan 25, 2022·Twitter Web App

Ron DeSantis
@GovRonDeSantis

Floridians have benefited from the state’s treatment sites and their access to treatment shouldn’t be denied based on the whims of a floundering president.

8:50 AM · Jan 25, 2022  Twitter Web App

[Fishrrman]

This is political punishment, pure and simple.

What if Mr. DeSantis were to make efforts at importing such antibodies from sources other than the U.S. government?

Perhaps by dealing directly with other countries?

These are extraordinary times, and require extraordinary means...

[Right_in_Virginia]

thebradfordfile
@thebradfordfile

Florida's current death rate is less than half of New York, in case you were wondering why the FDA changed the rules on monoclonal antibodies. These people are evil.


11:10 PM · Jan 24, 2022·TweetDeck