FDA
The Food and Drug Administration directly affects your life every time you swallow a pill - Joe Graedon
image by: The U.S. Food and Drug Administration
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The F.D.A. Has Reached a New Low
In recent years, under steady pressure from the pharmaceutical industry and the patient groups it funds, the F.D.A. has progressively lowered its standards of effectiveness and safety required for drug approvals. New drugs are now more likely to be supported by fewer studies and less adequate clinical trial designs than in the past. Worse, more than half of new drugs are now approved based on what’s called surrogate endpoints — changes in the body measured by lab tests that may not reflect clinical benefit — rather than requiring that the drug affect how a person feels, functions or survives.
Resources
How the FDA should protect its integrity from politics
The US drug regulator is accused of misrepresenting data on COVID-19 therapies. A decade ago, it set criteria to ensure its decisions are driven by science.
Is FDA Credibility Irreversibly Damaged?
You rely on the FDA to guarantee the safety of your food and medicine. Do you trust the agency? FDA credibility is at an all time low.
Another FDA Blunder
How the Food and Drug Administration botched the vaccine-approval process for young children
Biden’s FDA Should Heed Own Advice and ‘Follow the Science’ on Vape Products
Instead of focusing on fixing the baby formula crisis that continues to be a problem, the FDA instead rolled out a series of tobacco-related decisions, not backed by science, to earn a quick win that would shift media headlines.
Credibility: Business Lessons From FDA And CDC
Credibility management comes down to one basic rule: speak the truth and act on the truth. For those who think this needs elaboration, we can add some details.
FDA Struggles to Retain Credibility
Dealing with the COVID-19 pandemic has been disastrous for FDA. A series of actions signaling premature support for unproven treatments promoted by the White House has undermined confidence in the agency’s decisions and independence.
Honesty is Hardly Ever Heard, And Mostly What FDA Needs From Your Firm: Handling a Regulatory Call or Meeting With FDA
Part of our day-to-day job is to help clients respond to FD-483s, Warning Letters, and other compliance and enforcement actions brought by FDA and similar regulatory bodies.
Risky Drugs: Why The FDA Cannot Be Trusted
This evidence indicates why we can no longer trust the FDA to carry out its historic mission to protect the public from harmful and ineffective drugs. Strong public demand that government “do something” about periodic drug disasters has played a central role in developing the FDA. Yet close, constant contact by companies with FDA staff and officials has contributed to vague, minimal criteria of what “safe” and “effective” mean.
The FDA is 5X too worried about long term credibility
Readers should absolutely question my assumptions. This post is a simplified back-of-the-envelope exercise because I believe all of the discussion so far has only been qualitative. If you think any of my assumptions are substantively wrong (and I’m sure some are!), it’s best to propose a quantitative alternative.
Why FDA Approval Doesn't Guarantee Drug Safety
The U.S. Food and Drug Administration is supposed to protect Americans from harmful drugs. But in reality, FDA-approval does not guarantee safety. Critics say Big Pharma funds FDA reviews of new drugs, creating a conflict of interest. The agency is too focused on approving drugs to appease Big Pharma and it lacks the proper authority and funding to protect the public.
The F.D.A. Has Reached a New Low
Decades ago, drugmakers in the United States could sell medicines without demonstrating that they actually worked. That came to an end in the early 1960s after tens of thousands of women worldwide gave birth to children with severe birth defects after taking the inadequately tested drug thalidomide.
FDA
The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.
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