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What does FDA approved mean?

It’s approved by the FDA, so it’s the best medication for me, right?

Actually, approval by the Food and Drug Administration does not confirm that a drug is the most effective or the safest drug you can take for your illness. It tells you that it has been shown to be effective for its proposed use and that its benefits outweigh its risks. It also tells you that the manufacturer of the drug spent millions to be granted FDA approval because it expects to earn millions more from the sales of its product.

FDA approval does not signify that it is any more effective, or safer or has fewer side effects than other, often less expensive alternatives.

How does a drug gain FDA approval?
Rigorous testing begins with animal studies, followed by a series of trials, each involving a larger group of people, up to about 3,000. Strict research guidelines, including at least two randomized controlled trials, are required. The process takes time and costs the drug maker millions of dollars.

An FDA review team made up of medical doctors, chemists, statisticians, pharmacologists, and other experts evaluates the studies to determine whether they agree with the sponsor’s results or whether they need any additional information to make a decision. Their conclusions and recommendations are then considered by team leaders, division directors, and office directors and sometimes advisory committees made up of outside experts. The FDA also inspects the facilities where the drug will be manufactured

If the FDA decides that the benefits of a drug are clear, and the risks are not excessive, the drug will receive approval and can be marketed in the United States.

Many older drugs are not FDA approved because their patents have expired, allowing affordable generic versions to be made. Many of these drugs have withstood the test of time and are prescribed by doctors who have found them to be effective. No manufacturer will earn substantial profits on these drugs and, thus there is no one to pay the price of gaining FDA approval.

What about off-label uses?
Drugs are approved only for the use studied. “Off-label” use is when the drug is used “for indication, dosage form, dosage regimen, population or other use parameter not mentioned in the approved labeling.” The drug’s manufacturer is not allowed to advertise the drug for off-label use, but doctors may legally prescribe a drug for a use not approved by the FDA, and in fact, the FDA “recognizes that off-label use of drugs by prescribers is often appropriate and may represent the standard of practice.” Within the medical community, prescribers develop, publish and exchange information about the most effective treatments for their patients.

For example, no mood stabilizers have been FDA approved for bipolar II disorder, says author and psychiatrist Dr. James Phelps, only for bipolar I symptoms. Most medications used for bipolar II, such as lithium, valproate (Depakote), lamotrigine (Lamictal), and numerous others, are prescribed off -label.

What else should I know about the FDA?
The Food and Drug Administration is sometimes criticized for its prolonged approval system which delays making drugs available to the people who need them (although in recent years, the review time has been cut in half).

But, they’re also criticized for approving drugs too quickly, without taking time to discover problems that may show up only after long term use.

The $500 million to $800 million price of FDA approval allows only the most well-funded manufacturers to participate in the process, and contributes to high prices for medicines.

Drug makers can pay fees to speed up the approval process. Although the money supports increased FDA staff and upgraded technology, critics question the ethics of the arrangement. Suggestions of conflict-of-interest have been made because of the stock options, grants and consulting fees some FDA advisors receive from drug manufacturers.

Critics question the usefulness of a system that, increasingly in recent years, has approved drugs for narrowly defined and limited uses. For example, lamotrigine (Lamictil®) is approved for “maintenance treatment of bipolar one”, but not for bipolar depression; whereas quetiapine (Seroquel®) is approved for bipolar depression, but not for maintenance treatment. This makes it difficult for consumers to become informed about the medications they take.

The Food and Drug Administration, and the drug approval process, has its flaws and limitations, but it can be counted on to mission is to promote and protect the public health. They also prevent drug makers from making misleading, false and flagrant claims made for drugs. But anyone who takes medications must be an informed consumer. If the drug is approved, that should provide a reliable measure of its effectiveness and safety. But, other drugs may be just as effective, if not more so and may have a lower cost or fewer side effects. Do your own research. And discuss your findings with your doctor.

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