Could the 21st Century Cures Act Compromise Patient Safety?
August 14th, 2015|
The U.S. Food and Drug Administration (FDA) is responsible for regulating the safety of medical products released in the United States. They achieve this through strict policies that require testing of any new drug or medical device. Our defective product lawyers at Fleschner, Stark, Tanoos & Newlin explain a new law has been introduced to federal lawmakers that could potentially compromise the agency’s ability to ensure the safety of medications and medical devices in our country though.
The 21st Century Cures Act was passed through the House of Representatives last month and will now go before the Senate for consideration. The bill is intended to enhance the development of medical technology in the U.S., but in doing so, could put the health and safety of patients at risk.
According to Health News Review, the 21st Century Cures Act would allow new medical devices to submit case studies as evidence of a product’s safety for premarket approval. Current law requires these new products to undergo rigorous studies that can quantify the safety of a product, rather than simply depending on the results that were found in a small batch of tests.
Not only would the bill lower the standards for proving a product’s safety, but it could also present a conflict of interest in how evidence of a product’s performance is gathered. That’s because the bill allows companies to hire independent, third parties to conduct the testing of devices.
Protecting the public from the dangers of a defective medical device is a top priority for our Terre Haute personal injury attorneys at Fleschner, Stark, Tanoos & Newlin and we’re hopeful lawmakers will carefully consider the benefits and risks of the 21st Century Cures Act before voting on the measure.