Misplaced Trust: Why FDA Approval Doesn’t Guarantee Drug Safety


When 37-year-old Timothy “Woody” Witczak’s doctor gave him a few Zoloft (sertraline) samples to help him sleep in 2003, neither he nor his wife, Kim, was alarmed

“Woody and I never once questioned the drug. Why would we? Zoloft is FDA-approved, given to him by his doctor, and advertised and sold as safe and effective,” Kim told Drugwatch […]

Five weeks later, Woody — a happily married, energetic, compassionate and cheerful man with a successful career — was dead. He had hung himself in the garage […]

The family discovered Zoloft, an FDA-approved antidepressant, led to Woody’s tragic death.

Unfortunately, what Woody’s family didn’t know is the FDA’s approval process may favor drug companies over consumers — and FDA-approval does not guarantee safety. In fact, Big Pharma actually pays for the majority of drug safety reviews, provides the FDA with safety data for the review and has the option to have drugs approved faster with fewer clinical trials […]

“FDA approval is based on evidence — provided by the company that makes the medical product — that the benefits of the product outweigh the risks for most patients for a specific use. It doesn’t necessarily mean the product is safe.” – Diana Zuckerman, President, National Center for Health Research

Each year, more than 2 million Americans suffer serious adverse reactions from FDA-approved drugs like Zoloft. Each year, severe side effects kill roughly 1 in 20 people who experience them

Each year, severe side effects kill roughly 1 in 20 people who experience them

While taxpayers still provide about one third of the FDA’s funding, the agency receives the majority of its drug-review funding from Big Pharma — the very industry it should be regulating. It’s a little-known fact to most Americans, and it raises red flags for a number of consumer groups […]

“Taxpayers are also paying for agency [funding], but we’re not treated as the customers — the companies are,” Zuckerman said.

Under the Prescription Drug Use Fee Act (PDUFA) of 1992, drug companies pay user fees to get drugs approved. Initially, Congress passed PDUFA to provide a budget to hire more medical scientists and researchers to deal with the drug application load […]

Witczak stresses education. She says consumers should challenge their physicians and find out all they can about a drug. The FDA also needs more authority to compel recalls and police drug and device companies.

“It was too late for our family,” she said. “But if just one family is informed, then Woody’s life and death made a difference.”

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