How does a drug recall work?

| Jun 8, 2018 | Medical Product Liability

As many residents of Georgia may already know, the federal Food and Drug Administration, or FDA, approves most all drugs, medications and the like that come on to the market before they are given to customers.

However, this does not mean that the FDA is infallible when it comes to approving or disapproving drugs. Many times, it turns out that after further investigation and additional experience with a drug, the drug has some serious hazards associated with it that make it simply not worth keeping on the market.

To make this decision, the FDA and manufacturers monitor the drug’s performance on an ongoing basis and also review complaints about the drug. In most cases, when it turns out a drug is causing unanticipated medical problems, either on its own or when used with other drugs, the manufacturer and FDA will agree to a voluntary recall of the drug. This means the manufacturer needs to collect the drugs that are still on the market and offer customers refunds, replacements or a fix for the problem.

Recalls should not be confused with a “withdrawal” of a drug from the market. In the lingo of the pharmaceutical business, a “withdrawal” is simply a manufacturer’s decision not to distribute the drug and to allow its supply to gradually dwindle.

It is important for Georgia residents to remember that a recall is not intended to compensate victims of a dangerous drug. The only hope for compensation one might have following a recall is, as mentioned, a refund of the price of the drug. To get compensation for an injury, one would need to file a medical product liability lawsuit.