Are All Drugs on the Market FDA Approved?

Are All Drugs on the Market FDA Approved?

You might assume that a drug prescribed by your doctor or available on the shelf at your local store has received approval by the Food and Drug Administration (FDA). However, the reality is that not every drug marketed in the U.S. has been approved by the FDA. That’s right: you can purchase drugs that have not been evaluated for safety and efficacy.

FDA’s Unapproved Drugs Initiative Targets Unsafe Drugs

In 2006, the FDA launched the Unapproved Drugs Initiative to take potentially unsafe drugs off the market. The initiative specifically seeks out drugs with safety risks, those that lack evidence of effectiveness, health fraud drugs, and drugs that are reformulate to evade an FDA enforcement action, among others. Since the initiative began, the FDA has removed roughly 550 unapproved drugs from the market.

How do these drugs make it to market without being FDA approved? Some companies simply bypass the FDA and take their drugs directly to market, according to Dr. Michael Levy, director of new drugs and labeling compliance at the FDA. Sometimes these medications are even prescribed by doctors, as they show up on drug registries just as approved drugs do. These drugs also have inserts that look the same as those of approved drugs and are covered by insurance benefits.

In other cases, some drugs were made available prior to FDA rule changes but no longer meet safety or efficacy requirements.

The FDA database provides details about all FDA approved drug products. You can visit the website to look up any drug to see whether it has been approved.

“If you are taking a medication that has not received FDA approval, you should consult with your healthcare provider about the safety of the drug,” said Attorney Walter Clark, founder of Walter Clark Legal Group.

Our firm has been handling personal injury cases throughout the California Low Desert and High Desert communities for over 30 years. With a 95% success rate, the California personal injury attorneys at Walter Clark Legal Group will fight to hold those responsible for your loss accountable and win compensation to cover medical bills, lost wages, and pain and suffering. If you have been injured by a drug and want to discuss your legal options, contact us today at (760) 777-7777 for a free consultation with an experienced personal injury lawyer. We have offices in Indio, Rancho Mirage, Victorville, and Yucca Valley and represent clients through the entire California Low Desert and High Desert communities.

DISCLAIMER: The Walter Clark Legal Group blog is intended for general information purposes only and is not intended as legal or medical advice. References to laws are based on general legal practices and vary by location. Information reported comes from secondary news sources. We do handle these types of cases, but whether or not the individuals and/or loved ones involved in these accidents choose to be represented by a law firm is a personal choice we respect. Should you find any of the information incorrect, we welcome you to contact us with corrections.