The Myth of ‘FDA Approved’ and Drug Safety

by Jim Orr

The Michigan state legislature passed a law in 1996 providing that “a drug is not defective or unreasonably dangerous”—and thus the manufacturer is not responsible for injury and death resulting from a drug— “if the drug was approved” by the FDA. The basic idea of the law is that if the FDA approved it, it must be safe. Fortunately for all those who don’t happen to own a drug company, no other state has placed such absolute, blind trust on our overburdened federal drug approval system.

There are more than 11,000 FDA-regulated drugs on the market and nearly one hundred more approved each year. If you think the FDA has tested these drugs and determined the drugs are safe and effective before approving them, think again.

FDA approved drugs have actually been tested only by the same drug companies that plan to profit from selling the drugs they test. The FDA does not test the drugs. One more time: the FDA does not test the drugs. Here it is from the FDA’s website:

What’s the role of the FDA in approving new drugs & medical treatments?

The Food and Drug Administration’s job is to make sure medical treatments are safe and effective for people to use. However, FDA does not develop new therapies, or conduct the clinical trials to demonstrate safety and effectiveness.

“When you fill a prescription for a relatively new drug, you are entering, in effect, a vast and unregulated human experiment,” explains a Johns Hopkins Medicine Health Alert. After a drug is approved, the results of this ongoing “unregulated human experiment” are also monitored largely by only the drug companies. The FDA depends on the drug companies – and the public – to report when bad things happen while using “approved” drugs. If a drug company does not report or is very slow to report, the FDA will typically have no reason to suspect a problem until a report is made

Should we depend entirely on a system that relies so heavily on the drug companies themselves? In a brief filed with the Supreme Court, ten former and current editors and authors of the New England Journal of Medicine (NEJM) detailed examples of companies such as Merck, Wyeth and Bayer Healthcare withholding important information from the FDA regarding the safety of certain drugs, costing many lives. The brief goes on to explain the problems with relying on the FDA as the “sole monitor” of drug safety.

More recently, concerns about major drug companies paying for research favorable to the opioid painkilling drugs they sell has become serious enough that the United States Senate Finance Committee has launched an investigation. The same Senate committee recently concluded that the medical device company Medtronic manipulated research studies to make its products appear safer. We reported the results of that investigation in a previous blog post on our website.

The Union of Concerned Scientists has produced a piece addressing “Three Myths about How the FDA Drug Approval Process Works.”

It is an unfortunate truth in the United States that all too often a drug company’s decision regarding whether to conduct research about a drug or medical device or whether to share the results of such research with the FDA and the public is not based on the health, safety and welfare of the people who use their drugs and medical devices. It is instead motivated by their desire to avoid taking responsibility for their mistakes and threatening their enormous profits. Given the billions of dollars the pharmaceutical industry makes from the sale of their drugs each year, it is no wonder so many companies hide negative research results.

At Heygood, Orr & Pearson, we believe when a drug company sells a drug or medical device that is dangerous and unsafe they should be held responsible for the damage caused by doing so. We have spent years holding drug companies and medical device manufacturers responsible for the injuries and deaths caused by their reckless conduct. From dangerous fentanyl pain patches to defective hip and knee implant devices to Yaz, Actos, Avandia and Accutane, the lawyers at Heygood, Orr & Pearson have made it a career priority to hold drug manufacturers accountable and responsible for their actions

Contact the law firm of Heygood, Orr & Pearson for a free consultation so we can help you determine the best way to protect your legal rights and interests. You can reach us by calling our toll-free hotline at 1-877-446-9001, or by filling out our free case evaluation form located on this page.

by Jim Orr

Jim Orr is a licensed attorney and a partner at HO&P focusing on business and personal injury litigation. Jim was selected multiple times to the Super Lawyers List and has tried 70+ cases to verdict.