The U.S. Food and Drug Administration (FDA) is tasked with overseeing the safety of a number of products. However, its authority isn’t as great as many Americans assume it is — and as some lawmakers would like it to be.
The FDA can recall many of these products, including vaccines and medical devices, if they’re found to be dangerous or defective. It’s been less than a decade since President Obama signed food safety legislation that — among other things — gave the FDA power to recall unsafe food, and only if the company behind it refuses to do so.
However, the FDA still can’t recall drugs. The most the agency can do is urge drug companies to recall unsafe products and try to get them as well as pharmacies to notify customers about the potential danger.
The FDA can and does issue its own safety warnings. However, drug recalls have to be voluntarily done by the manufacturer. The FDA can’t penalize drug manufacturers if they refuse to recall a product.
The same lawmaker who introduced the bill that President Obama signed in 2011 is still working to give the FDA more authority — whether the agency wants it or not.
As the 2020 congressional session got underway, Congresswoman Rosa DeLauro reintroduced a bill called the Recall Unsafe Drugs Act. Some of her Democratic colleagues have also signed on to the proposed legislation that would give the FDA the authority to mandate drug recalls.
The bill is going to face some opposition from the pharmaceutical industry, which claims that it typically complies with FDA requests for voluntary recalls. According to at least one media report, FDA officials don’t want the power to require drug recalls.
It remains to be seen whether this bill is able to gain any traction in a Congress that’s divided on issues large and small along partisan lines. That’s why it’s essential that consumers to pay attention to safety alerts — particularly when it comes to prescription as well as over-the-counter drugs.
One way that consumers can incentivize drug manufacturers to pull potentially dangerous products off the shelves is to take legal action when a drug has caused them to suffer harm. If this has happened to you or a loved one, an experienced attorney can provide valuable guidance.