Tag: FDA
Why the Hell Has the FDA Not Approved Cheap Rapid COVID-19 Self-Tests Yet?
“a bin of at-home rapid Flowflex COVID-19 tests for sale for about $3.50 apiece at a supermarket in the Netherlands. The test is manufactured by a company headquartered in the U.S., but the Food and Drug Administration (FDA) has not approved it for sale here. In the bin below the Flowflex test, you’ll see another COVID-19 self-test offered by Roche. You can buy it in the Netherlands for about $5.90 per test. It too is not approved by the FDA.”
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“From the beginning of the pandemic 20 months ago, hypercautious federal bureaucrats have massively bungled COVID-19 diagnostic testing. Way back in March 2020, I argued that the FDA should get out of the way of rapid at-home COVID-19 testing. Instead, the agency prevented private companies and academic labs from developing and deploying any COVID-19 tests. It especially took its sweet time approving at-home diagnostic tests. The first real at-home COVID-19 wasn’t finally approved until mid-December.”
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“If cheap rapid COVID-19 self-tests are good enough for Europeans, surely they are good enough for Americans.”
The FDA Wants To Lower Nicotine in All Cigarettes, Which Will Make Smokers Smoke More
The FDA Continues To Drag Its Feet on Vaccine Approval
“the FDA’s approval is coming nearly two weeks after British regulators greenlighted the same vaccine, and almost a month since Pfizer/BioNTech submitted its final data for the agency to review.
Had the FDA acted more swiftly—say by bumping up the December 10 meeting it held to recommend approval of the Pfizer vaccine—Monday’s good news could have arrived a few weeks earlier. Meanwhile, the advisory committee tasked with evaluating another vaccine developed by Moderna is not set to meet until Thursday.
Given the slow rollout of these vaccines (slow, at least, when considered against the number of people needing to be vaccinated), it’s easy to think that the delay of a few days or weeks isn’t all that consequential.
Not so, says George Mason University economist Alex Tabarrok, who deploys some back-of-the-envelope math to argue that a few thousand people will die for every day the FDA dawdles in approving new vaccines.”
FDA Relaxes Rules To Allow for More Ventilators, Finally
“The Food and Drug Administration (FDA) is easing up on some regulations so that ventilators can be manufactured and implemented more quickly to respond to the spread of COVID-19.”
Health Bureaucrats Botched the Response to Coronavirus. Trump Made It Even Worse.
“The single most important failure of the U.S. response to COVID-19, the disease caused by the novel coronavirus, has been the slow rollout of testing. This was an abject failure of bureaucracy. But it was also a failure of presidential leadership.
The countries that have had the most success in containing the outbreak, such as South Korea and Singapore, have done so through early, rapid, and widespread testing and contact tracing, followed by targeted quarantines. South Korea and the United States discovered initial cases of the coronavirus on the same day in January. Since then, some 290,000 people in South Korea have been tested and new daily cases have fallen from 909 to just 93. Despite a much larger population, the United States, tested just 60,000 people in the same period of time.”
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“Much of the failure to make mass testing available lies with the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). As a Wall Street Journal report makes clear, the CDC, which managed the development of the initial test kits, botched the job in just about every possible way: The CDC not only produced a faulty test that had to be retracted but adopted narrow testing criteria that meant many people with symptoms simply couldn’t be tested.
Perhaps most disastrously, as The Washington Post reports, federal health agencies initially declined to certify tests produced by private companies that were better suited for rapid mass testing anyway. This is despite the fact that experts, including the former head of the FDA, were publicly recommending that they do so as early as February 2.
The CDC was following its usual protocols, developing initial diagnostic tests on its own in order to maintain quality control, as it usually does. But that’s exactly the problem.”
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“But this was also a failure of political leadership, most notably from President Donald Trump. For weeks, Trump and senior White House officials actively downplayed the threat of the virus.
As late as February 25, National Economic Council adviser Larry Kudlow was offering assurances that the coronavirus was “contained” and that it was “pretty close to airtight.” Trump treated the virus with similar breeziness, suggesting that the virus was “going to disappear” and that while it might get worse, “nobody really knows.””
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“The problem here is obvious: Trump, who as the head of the executive branch oversees federal agencies such as the FDA, did not view the virus as a serious problem—and did not want others to view it that way either. That, in turn, translated into a downstream lack of urgency, which meant that critical aspects of the response were not prioritized. According to The Wall Street Journal, health officials who have examined the testing calamity have concluded that it was a result of both bureaucratic bumbling and a “broader failure of imagination,” in which Trump and other administration officials “appeared unable or unwilling to envision a crisis of the scale that has now emerged.”
The job of a president is to make decisions, set priorities, and convey clear information to both the public and the staff of the executive branch. This is especially important in a moment of crisis, when the executive is in charge of acting both quickly and with sound judgment. In this outbreak, Trump has failed on every count. Not only did he fail to see the threat even when it was apparent to experts, but he actively undermined preparedness by downplaying its significance far long after the problem was apparent, and by providing false and misleading information as the mitigation effort proceeded.”
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“The federal health bureaucracy deserves much of the blame for America’s faltering response to the coronavirus outbreak. But the president has made the fiasco worse.
The bureaucracy reports up to an executive, who is tasked with setting priorities and ensuring performance—and for taking responsibility when there are failures. Instead, Trump has inaccurately blamed the Obama administration for failures that occurred on Trump’s watch. (Indeed, under Barack Obama, diagnostic tests for swine flu were designed and approved in less than two weeks.) Asked whether any of this is his fault, the president rejected the idea, saying, “I don’t take responsibility at all.” Trump’s refusal to admit failures makes it more likely that he will repeat them, and that more Americans will pay the price.”