FDA Overview

The Center for Drug Evaluation and Research (CDER) is the division of the US Food and Drug Administration (FDA) that is responsible for evaluating and approving new prescription, generic and over-the-counter drugs before they can be sold. It is the CDER's job to ensure that these drugs work correctly and that their health benefits outweigh known risks. CDER is also responsible for overseeing the research, development, manufacture and marketing of drugs; ensuring that advertisements for prescription drugs are truthful; and monitoring drugs that have been approved for unexpected health issues. If health risks are discovered after a drug is approved, CDER informs the public of the risk, ensures that changes are made to the drug's label and, if it is necessary, removes the drug from the market. If you have questions about the approval or removal of a particular drug from the market, health risks related to a drug or litigation regarding those risks, talk to an attorney.

Drug Approval Process

Neither FDA nor CDER test, manufacture or develop drugs. Drug manufacturers submit studies of their drugs so that CDER can evaluate the data in determining whether the drug works for its intended purpose and whether its benefits outweigh its risks. If a drug is approved, it does not necessarily mean that it is completely 100% safe. If a drug is approved, it generally means that the benefits and risks have been evaluated by CDER and that the benefits outweighed the risks and it is generally safe and effective. All drugs have side effects, most of them not serious or harmful. A drug's label must list the known benefits and risks.

Drug Recalls

Most recalls are voluntarily made by manufacturers or distributors of drugs regulated by FDA. A company may discover that one of its drugs has a defect and recall the drug on its own. FDA can also tell a company that it found one of its drugs to be defective and suggest or request that the company recall the product. Usually, the company will comply with FDA's request. If the company does not recall the product, FDA can seek legal action to seize available product or seek a court order requiring the company to recall the product. There are three categories of recalls:

• Class I: for dangerous or defective products that predictably could cause serious health problems or death
• Class II: for products that might cause a temporary health problem or pose only a slight threat of a serious nature
• Class III: for products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing regulations

Reasons for Recalling a Drug

Many complex factors go into deciding whether a drug should be taken off the market. One consideration is if the drug has caused rare, unpredictable problems. Drugs are typically tested in several thousand subjects, allowing for the detection of relatively common, serious adverse events. The practical size of clinical trials means we cannot know everything about a drug when it enters the market. Rare but serious side effects may only become known when much larger numbers of people use the drug.

There are also times when a drug's toxicity is known, but the drug turns out to be more toxic than the clinical trials suggested, which again may only be seen when the drug is used in larger numbers or in different ways.

Sometimes there may be a serious adverse reaction if the drug is combined with another drug or even certain foods. The discovery of harmful drug interactions may lead to changes in labeling or even a recall.

Other Risk Management Options

The main risk management tools employed by the FDA are education, through letters to health care professionals (known within the FDA as "Dear Doctor" letters), and labeling changes, such as new warnings, sometimes boxed in black for emphasis. FDA can also require the use of Medication Guides, which are labels specifically for patients that emphasizes significant risks and advises patients how to detect or avoid them.

MedWatch

MedWatch is FDA's program for reporting adverse events, serious reactions and quality problems with drugs. If you or a loved one has experienced a serious, adverse reaction to a prescription or over-the-counter medication, you can fill out a report online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm. Doctors and other health care professionals are also able to submit reports.

If you were harmed by a drug that has been pulled off the market, contact a personal injury attorney to discuss your claim.

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