Abolish the FDA

[acesfull86]

https://nymag.com/intelligencer/2022...ect-plant.html

As monkeypox cases have ticked up nationwide, the White House and federal agencies have repeatedly assured the public that millions of vaccine doses will be distributed to at-risk populations before the end of the year. Yet since the World Health Organization announced the global monkeypox outbreak in May, only tens of thousands of shots have been administered in the U.S. The slow start is due, at least in part, to the fact that 1.1 million doses have been stored in a Denmark pharmaceutical facility while the Food and Drug Administration has taken almost two months to approve their release here, according to people familiar with the situation. FDA officials only began to inspect the facility last week. The lag time, public-health experts say, is indicative of the federal government’s lackadaisical approach to a growing public-health emergency.

…

It’s unclear why the FDA took so long to send inspectors to Denmark. The agency regularly conducted virtual inspections of drug facilities early in the COVID-19 pandemic, according to the agency’s guidance, and public-health activists are demanding answers. “Members of at risk communities are being turned away from monkeypox vaccination because these vaccines are not available in sufficient quantity in the U.S., but instead sitting in freezers in Denmark,” members of the advocacy group PrEP4All and Partners in Health wrote in a letter to federal officials overseeing the outbreak response last week.

Compounding their frustrations was the FDA’s refusal to accept an inspection done last year by its counterpart, the European Medicines Agency, which deemed the company’s facility in compliance with the FDA’s own standards.

“The FDA does not grant reciprocity for EMA authorization of any vaccines, for monkeypox or other diseases,” a spokesperson for the FDA said in a statement.

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Welp, seems the FDA learned nothing from its COVID mistakes.

Wish there would be a national conversation about this agency (and the CDC). If only they’d start carrying handguns or dressing in drag…

[sturg33]

https://nymag.com/intelligencer/2022...ect-plant.html

As monkeypox cases have ticked up nationwide, the White House and federal agencies have repeatedly assured the public that millions of vaccine doses will be distributed to at-risk populations before the end of the year. Yet since the World Health Organization announced the global monkeypox outbreak in May, only tens of thousands of shots have been administered in the U.S. The slow start is due, at least in part, to the fact that 1.1 million doses have been stored in a Denmark pharmaceutical facility while the Food and Drug Administration has taken almost two months to approve their release here, according to people familiar with the situation. FDA officials only began to inspect the facility last week. The lag time, public-health experts say, is indicative of the federal government’s lackadaisical approach to a growing public-health emergency.

…

It’s unclear why the FDA took so long to send inspectors to Denmark. The agency regularly conducted virtual inspections of drug facilities early in the COVID-19 pandemic, according to the agency’s guidance, and public-health activists are demanding answers. “Members of at risk communities are being turned away from monkeypox vaccination because these vaccines are not available in sufficient quantity in the U.S., but instead sitting in freezers in Denmark,” members of the advocacy group PrEP4All and Partners in Health wrote in a letter to federal officials overseeing the outbreak response last week.

Compounding their frustrations was the FDA’s refusal to accept an inspection done last year by its counterpart, the European Medicines Agency, which deemed the company’s facility in compliance with the FDA’s own standards.

“The FDA does not grant reciprocity for EMA authorization of any vaccines, for monkeypox or other diseases,” a spokesperson for the FDA said in a statement.

———————

Welp, seems the FDA learned nothing from its COVID mistakes.

Wish there would be a national conversation about this agency (and the CDC). If only they’d start carrying handguns or dressing in drag…

[acesfull86]

https://www.cato.org/blog/fda-modern...rgently-needed

Today the U.S. Senate passed, by unanimous consent, the FDA Modernization Act 2.0, co‐​sponsored by Senators Rand Paul (R‑KY) and Cory Booker (D‑NJ). The bill removes the mandate, included in the 1938 Food, Drug, and Cosmetic Act (FDCA), that requires all drugs to be tested on animals to exclude toxicity. The bill does not end animal testing, but it now permits drug developers to use alternative methods to test for toxicity when feasible. Similar provisions are in a bill passed earlier in the U.S. House of Representatives, making this reform likely to become law.

…

This bipartisan legislation is certainly commendable. But, to be fair, it’s low‐​hanging fruit. The FDCA needs much more comprehensive reform and must be made consistent with its authors’ pledge to respect the people’s right to self‐​medicate.

In our white paper “Drug Reformation,” Michael Cannon and I provide a laundry list of reform proposals, ranging from ending the FDA’s monopoly over deciding which drugs may be over‐​the‐​counter and which may be prescription‐​only, to allowing Americans to purchase drugs that have been approved by designated certification agencies, including foreign regulatory bodies. We point out:

According to one study, recognizing drug approvals by regulatory bodies in Canada and Europe between 2000 and 2010 would have given U.S. consumers quicker access to 37 “novel” drugs for which “no other FDA‐​approved prescription medicine had the same mechanism of action,” including 10 drugs treating mostly orphan diseases “for which no alternative therapy was available in the USA.” Such recognition would have allowed U.S. consumers to access those drugs a median of 13.6 months earlier.

[nsacpi]

Paul and Booker are to be commended for working on this.