Frequently Asked Questions

HOW CAN A DRUG BE DANGEROUS IF IT WAS APPROVED BY THE FDA?

The drug approval process is lengthy and complicated. The FDA reviews all data provided to it by the manufacturer of the new drug in an attempt to determine if the compound will be safe in humans. But the FDA doesn't conduct any testing on the new drug. The agency is at the mercy of the manufacturer to disclose all information about the drug. This creates a conflict of interest between the FDA, which needs all relevant data, and the manufacturer, which wants the drug approved as quickly as possible.

It is true that no drug is completely safe. This is why doctors weigh the risks of the drug against the benefit they can expect their patient to receive. But often times, risks are downplayed by drug manufacturer sales representatives in order to compete with other, similar drugs. When this happens, the number of serious reactions to the drug increases.

WHY DOESN'T THE FDA DISCOVER THE DANGERS OF NEW DRUGS DURING TESTING?

The FDA performs no testing on new drugs. Rather, the manufacturers perform the testing and then send the results in a document called a New Drug Application. These are massive documents - enough to fill a tractor trailer in years past. The FDA then reviews the material and decides whether to approve the new drug for market. The problem with this system is the FDA is a comparatively small federal agency, with very limited resources. On the other hand, the drug manufacturer has hundreds of millions of dollars invested in a potential new drug, and failure to obtain FDA approval can be disastrous financially. This system sets the manufacturer in opposition to the FDA, and often times colors the results and data drug companies send to the agency.

HOW ARE DRUGS WITHDRAWN FROM THE MARKET?

Once a drug is approved, the manufacturer has an obligation to conduct analysis of what is called "post-marketing data." This data is complied from further tests on the drug and from doctors and patients who are using the product, and gives the manufacturer a developing picture of the drug's safety record. But many times, this new data isn't finding new risks, but only confirming what was seen in early tests. Many times, manufacturers will see negative results in pre-approval trials, but will adjust the data before submitting it to the FDA to ensure approval. Post-marketing data is harder to explain away. Typically, it is material like this that attracts scrutiny.

When the FDA learns of further risks with a drug, it usually convenes a group of experts to analyze the data and make a recommendation. This is called an "Advisory Committee." The recommendations of these committees usually are what motivates the withdrawals of drugs. Many times, manufacturers will realize that a recommendation for withdrawal is in the works and will preemptively "voluntarily" withdraw the drug. This helps in post-withdrawal spin, and permits the company to announce that it has voluntarily taken measures in the interests of patient safety, and was not ordered to do so by the FDA.

If you or a loved one has been harmed by a defective drug or a defective medical device, please call or email our experienced pharmaceutical injury and product liability lawyers today. We'll evaluate your claim for free and help you get the justice you deserve.