FDA Recall Essay

Pharmaceutical drugs and medical devices are regulated by the Food & Drug Administration (FDA). Before a new drug or medical device enters the market, the manufacturer must complete clinical tests to prove the safety and effectiveness of the product. Those tests are then submitted to the FDA for review. Only when the FDA approves the product can it be placed on the market.
Once a drug or medical device has received FDA approval, manufacturers are still required to report any problems that arise to the FDA. Consumers are also encouraged to report problems or side effects through the MedWatch program.
What Prompts A Recall?
After investigating reported problems or negative side effects of a particular drug or medical device, the FDA may choose to

• Manufacturer recall – This is the most common way recalls are initiated. If the manufacturer becomes aware of a potential safety hazard, it can choose to voluntarily recall the product.
• FDA request – The FDA can ask the manufacturer to issue a voluntary recall if it feels a drug or medical device is unsafe.
• FDA order – If a manufacturer does not comply with a FDA recall request, the agency can seek court authority to order a recall or seize the drug.
Once a determination has been made to initiate a recall, consumers are notified in a number of ways.
• Direct notification – The manufacturer will notify any resellers of the product about the recall. The resellers will then stop distributing the products and, if necessary, contact any consumers that purchased the product from them.
• Public notification – The FDA posts information about all recalls on its website that is free for the public to check.
• Media coverage – Many times the public is notified through the media. Recalls – particularly for products that are widely used – usually draw heavy media coverage from online and television news organizations.
What Can I Do If I Have Been Injured By A Recalled Drug Or