Is the FDA Failing to Protect us From Dangerous Drugs and Medical Devices?

By Bill O'Mara, Chesapeake Dangerous Drugs Lawyer

The U.S. Food and Drug Administration (FDA) is charged with making sure the drugs we take and medical devices we use are safe?

So how come so many lawsuits have been filed over dangerous pills and medical devices?

Critics of the FDA point to shortcomings in the processes that allow products to go on the market as well as those that trigger recalls. The FDA came into being in 1906 when the Pure Food and Drug Act was passed.

“FDA was our country’s first consumer protection agency and Americans have relied on FDA to ensure the safety of their food and drugs for 100 years,” said Representative Henry A. Waxman at a ceremony in 2006. “Under the Bush Administration, FDA has undermined enforcement and betrayed its consumer-first legacy. FDA must start enforcing the law and return to a culture that places public health concerns ahead of industry profits.”

Waxman is a Democrat. Some of his harsh comments for the FDA should be put in the context of his criticism of the Bush administration.

He is one of many voices that have raised concerns about the FDA.

John Cooper of Cooper Injury Lawyers talks about dangerous drugs and devices

In a report, the Union of Concerned Scientists, voiced its concerns after the drug giant Merck voluntarily withdrew its pain medication Vioxx from the market after evidence was discovered that it put patients at increased risk of heart attack while taking the drug.

In testimony before the Senate Finance Committee, a reviewer in the Food and Drug Administration's (FDA) Office of Safety Research claimed that the agency's system for evaluating the safety of drugs is broken and fails to protect public safety.

Dr. David Graham claimed that the FDA's procedures and culture meant it is impossible to properly investigate drugs, the ongoing safety monitoring after the approval of a drug is especially compromised, Graham claimed in his November 2004 testimony.

The Controversial 510 (K) Clearance Process

The FDA has also come under fire over a fast track clearance system that allows new medical devices to go onto the market if they are similar to other devices that are already there. The 510 (k) clearance process has allowed a number of devices that have later been linked to serious complications including metal-on-metal hips and transvaginal mesh products to skip the costly and time-consuming clinical and observational trials before going on the market.

The FDA has also been dogged with concerns about technology, Recently, officials at the congressional watchdog, the Government Accountability Office (GAO) told the FDA it needs to identify information technology that will allow regulatory staffers to have better oversight.

It all adds up to a very real concern that the FDA is influenced by the big drug companies and not sufficiently in the corner of patients.

If you or a loved one has been injured by a dangerous drug or medical device, call us at Cooper Hurley Injury Lawyers for a free consultation at (757) 455-0077 or see

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