Consumer Safety Information

Before any drug or medical product can hit the U.S. market, it must receive approval from the FDA. There are several ways a product can be approved. Typically, a product requires clinical testing and a review process to confirm that the product meets the need intended by the manufacturer without causing significant harm in the process. A standard FDA review takes roughly ten months.

Other forms of FDA approval are intact for particular products, such as those that accomplish an unmet need. Programs such as the FDA Fast Track, Accelerated Approval, and Priority Review may apply to these products so that they can be released onto the market more quickly. The 510(k) Premarket Notification process allows a drug or device to be approved if the manufacturer can prove substantial similarity to an existing drug or product.

In 1992, the FDA enacted the Prescription User Drug Fee Act (PDUFA). Under PDUFA, the FDA collects fees from drug companies that file new drug applications. These fees help to fund the resources required to approve new drugs and medical devices. However, many feel that this act puts the FDA inside the pockets of the U.S. drug industry and creates a conflict of interest.

Before taking a drug or receiving a medical treatment, patients should be prepared to ask questions to ensure that they fully understand the process and the potential side effects. In many cases, patients who become injured feel that they were not adequately informed of the possibility of harm prior to beginning the treatment.

Patients should ask the following questions: What side effects may occur? What are the associated risks, and do they outweigh the benefits? Will this medication interact with other medications? Can any pre-existing medical conditions cause complications?

Consumers should be aware of the basic rights they are entitled to when making purchasing decisions in the United States. In March 1962, President John F. Kennedy gave a speech to the U.S. Congress. During this speech, he discussed four basic rights of the consumer. This became known as The Consumer Bill of Rights. Later, the four tenants were expanded to eight through the United Nations Guidelines for Consumer Protection.

The Right to Safety

This right states that consumers should never be harmed by products if the products are used as recommended. In 1972, the Consumer Product Safety Commission (CPSC) further formalized this right. The CPSC has jurisdiction and powers allowing it to establish standards of performance and require warning labels and product testing.

The Right to Be Informed

Under this right, businesses are obligated to provide consumers with adequate information to make informed and intelligent product choices. Businesses should always be truthful and complete when providing product information. This right pertains to areas of advertising, financing, labeling, and packaging of products.

The Right to Choose

Consumers should have several options by different companies before they make a purchasing decision. To ensure this right, the federal government takes several steps to ensure a healthy environment that is open to competition. This is achieved by legislation that limits concept ownership, prevents monopolistic practices, and outlaws gouging and price cutting.

The Right to Be Heard

Consumers should be able to voice product concerns and complaints so that issues can be handled in an efficient and responsive manner. State and federal Attorney Generals can help aid consumers who have been victims of law violation by a business. The Better Business Bureau is intact to lobby and inspire action on behalf of consumers.