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., including 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 increase chemical analyses on batches of drugs, and alerting the public promptly if impurities or quality issues are found.
• 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.

– 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.