Help Us Make Your Prescription Drugs Safer With Improved Oversight By The FDA
Here’s an alarming fact: More than 2,000 pharmaceutical plants (both overseas and in the U.S.) have not been inspected by the Food and Drug Administration (FDA) in five years or more. This represents 42% of all 4,700 plants currently registered to produce drugs for the U.S. These facilities, which the FDA last reviewed prior to May 2019, produce essential medications such as antibiotics, blood thinners, and cancer treatments*.
This lack of inspections means that no one can know if these labs are taking the necessary steps to prevent contamination that can and has caused harmful side effects and even deaths.
What’s more, cuts to the HHS workforce starting in March 2025 have the potential to exacerbate the problem.
Recent cases of actual harm due to unregulated labs include blindness from eye drops tainted with bacteria, and impurities in dozens of brands of a chemotherapy drug that endangered an estimated 70,000 pediatric leukemia patients worldwide**. Despite this record of spotty oversight, medications from these uninspected facilities continue to flow into our pharmacies—and into our bodies.
Doesn’t the public deserve better?
At MedShadow, we are a non-profit that advocates for improved drug safety for all. We produce high-quality, independent investigative journalism to help people make decisions in their daily lives. At the same time, we aim to spark public discussion — and hold regulatory bodies accountable — when it comes to urgently needed changes throughout the entire drug manufacturing and distribution processes. No one at MedShadow — not staff, writers, or partners — ever receives financial support from the pharmaceutical or supplement industries. This commitment ensures the integrity and independence of our reporting and analysis.
All this is why we must fight to get more drug-manufacturing labs inspected now, and we need your help in making this demand heard—and acted on.
FDA inspections need to address these critical areas of drug safety:
- Quality Control: Mandatory regular inspections of all pharmaceutical manufacturing facilities.
- Thorough Testing: Implementing protocols to conduct chemical analysis on every batch of drugs to identify impurities or quality issues before they hit shelves.
- Decisive Action: Taking swift measures when FDA-approved drugs are discovered to have been approved using fraudulent information.
Thank you for joining with us to achieve our goal of safe, effective medicines for everyone who needs it.
Discover more about these urgent issues and our fight for safer medicines below.
– The MedShadow Team
References:
*Masquelier-Page, A. (2024, September 6). Nearly 2,000 drug plants are overdue for FDA checks after COVID delays, AP finds. The Associated Press.
**Joseph, A., & Hensley, S. (2024, January 25). Inside the investigation into chemotherapy drug asparaginase and its manufacturing flaws. STAT News.
@medshadow_foundation What can you do when the FDA fails to inspect thousands of drug manufacturing labs? @Health Journo Emma #fda #medicine #health #healthcare #inspection #medication #otc #prescriptionmeds #drugsafety ♬ original sound - MedShadow Foundation
Help us make your prescription drugs safer with improved oversight by the FDA.
THE PROBLEM
The Patient
The FDA
The Pharma Business
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WAYS TO HELP
donate
advocate
contribute
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FOLLOW THE FDA STORY
Medicines should be safe and effective for everyone.
Unfortunately, this is not the case. There are critical gaps in the FDA quality control process that can lead to contaminated drugs that make patients sick. Take a look at how we’re bringing these problems to light and calling on the FDA to address the shortfalls of inspections worldwide.
Tax Information: MedShadow Foundation is a 501(c)(3) non-profit organization and contributions are tax-deductible to the extent permitted by law. Our tax identification number is EIN 46-1326364
Turning Awareness into Action
Not all prescription and over-the-counter drugs are safe from medical harm.
Yet the FDA faces a backlog of over 2,000 drug manufacturing labs that haven’t been inspected.
And hundreds of drugs that may have been approved based on fraudulent trials are still on the market.
Now is the time to push for better safety standards and prevent further harm.
Helping Close the Gap
Throughout this campaign, we’ll be telling stories, sharing vetted and peer-reviewed research, and educating the public on the important side effects of their medications.
Our goal is to inform, inspire, and empower through clarity and actionable steps that drive meaningful change.
Together, we can work towards a future where 100% of drugs and their manufacturing facilities are tested, where greater transparency is the norm, and where we can trust that the medicines we take are safe and effective.
Maximizing Every Contribution
Not all prescription and over-the-counter drugs are safe from medical harm.
Yet the FDA faces a backlog of over 2,000 drug manufacturing labs that haven’t been inspected.
And hundreds of drugs that may have been approved based on fraudulent trials are still on the market.
Now is the time to push for better safety standards and prevent further harm.
